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Introduction

Over the past 30 years, Dr. Frank Critz and the other physicians of Radiotherapy Clinics of Georgia (RCOG) have treated more than 12,000 men for prostate cancer with a procedure called ProstRcision^® (pronounced PROS-ter-si-shun). The foundation of the ProstRcision treatment program has been long-term research focused on CURE of prostate cancer. From this research, over 80 research papers have been published in peer-reviewed medical journals or presented at medical conferences. RCOG has the oldest and largest seed implant program for prostate cancer in the United States. In fact, men have come to RCOG from all 50 states and from over 40 countries around the world to be cured by ProstRcision.

Based on our extensive experience managing this disease, we have developed this website to provide men diagnosed with prostate cancer and their families information they need to make an informed decision on how to be treated. This section of the website is written in a question-and-answer format, as if a man and his wife are speaking with an RCOG physician. These are questions that we hear from men every day, and they cover a wide range of topics, including how prostate cancer works, the prostate biopsy pathology report, the definition of cure, and how the 10 different treatment methods (see Table 1) compare in terms of overall cure rates.

Ultimately, we want to provide a decision-making process for selecting the best treatment for CURING prostate cancer. After all, the first question any man diagnosed with prostate cancer will ask is, “What is my chance for CURE?” You can click here to view a list of the 10 ways to treat prostate cancer listed by Overall Cure Rates. Following this introduction, you will find 136 Questions with Answers provided by RCOG physicians.

If you would like to speak directly with an RCOG physician, click here.

Frank A. Critz, M.D.
Mark L. Merlin, M.D.
James B. Benton, M.D.
Chad A. Levitt, M.D.
Frederick J. Schnell Jr., M.D.
Phillip D. Shrake, M.D.
Gary B. Stillwagon, M.D.

Table of Cure Rates

Cure of prostate cancer: What Treatment Is All About

There are 10 different ways to treat localized prostate cancer. Table 1 provides overall cure rates according to the 10 different treatment methods. Overall cure rate is the 10-year cure rate for all men (typically 1,000 or more), regardless of PSA, prostate biopsy pathology report findings or other medical data.

The purpose of Table 1 is to give men an Apples-to-Apples comparison of cure rates with a standard definition of cure, PSA cutpoint 0.2 ng/ml. To be cured of prostate cancer by any treatment, your PSA must become undetectable, which means it must fall to PSA 0.2 ng/ml or lower after treatment and remain at PSA 0.2 ng/ml forever, which is measured 10 years after treatment.¹ Table 1 shows the percentage of men, by treatment method, who have PSA 0.2 ng/ml or lower 10 years after treatment. For example, if 100 men are treated with ProstRcision, 83 will have PSA 0.2 ng/ml or lower 10 years later. The cure rates in Table 1 are from peer-reviewed prostate cancer research papers published in medical journals. If research papers were not calculated with PSA 0.2 ng/ml, the results were converted to this PSA level. More details on the 10 treatment methods are described in Questions 59–117.

The two methods with the highest cure rate for prostate cancer are ProstRcision and radical prostatectomy. Surgery and ProstRcision are both used for men with early and intermediate cancer, but ProstRcision is also used for advanced cancer. To give an equal comparison, Table 1 shows the cure rate of ProstRcision for early and intermediate cancers only, which is 88%, compared with 76-80% with surgery.

Personal Research

Question 1:
My name is John, and I am 64 years old. I had a routine physical and I’m in excellent health, except my internist discovered my PSA was 6.3 ng/ml. He sent me to a urologist who biopsied my prostate gland and a few days later told me I have stage T1c prostate cancer. He also told me that one of the 12 biopsy needle cores showed Gleason score 6 cancer, involving 10% of the needle with no perineural invasion.

I do not know what any of this means. All my wife and I know is that I have cancer, and we are very scared. My urologist wanted to schedule me for a robotic radical prostatectomy. I saw another urologist for a second opinion, and he recommended freezing my prostate gland through cryosurgery. I also met with two different radiation doctors. One recommended IMRT accelerator radiation, and the other said that seed implant would be the best treatment. Finally, I saw a fifth doctor who said I could be treated by any method and choose my own treatment. None of these doctors said anything about curing my prostate cancer; they talked only about treatment. After seeing all of these doctors, I am now both confused and frightened. I don’t know anything about prostate cancer or how to choose a treatment method. I just want to be cured of this cancer with the least problems.

Answer:
Your experience is typical of what men find when they are newly diagnosed with prostate cancer. The single most important thing you and your wife should do is perform your own research on prostate cancer and, above all, focus on curing your disease. There are three important reasons why you should do this:

You usually get only one chance to be cured of prostate cancer. Some men can be successfully treated after a recurrence, but most cannot. Therefore, you need to be certain that the treatment method and the doctor are the right choices for you.
Most doctors will recommend the treatment that they perform, but this may not be best for you. Urologists, who are surgeons, typically recommend a radical prostatectomy, and radiation doctors will recommend some type of irradiation. Unfortunately, it’s like buying a car. When you go to a Ford dealership, you will be told about Fords, and only Toyotas will be sold at a Toyota dealership. You should be aware that the treatment recommended by your doctor may not be best for your individual case of prostate cancer.
Doctors usually only talk about treatment of prostate cancer. They rarely discuss how well they cure this disease. This is because doctors rarely keep up with all the patients they treat. Your focus should be on cure, not just treatment. Any doctor can treat you, but the real question is “can a doctor cure you?”

These are the basic reasons why you should perform your own research. This section of the website will educate you about prostate cancer, but more importantly, it will empower you with an informed decision-making process that enables you to determine treatment based on cure rates for your own case of cancer.

Question 2:
How can I perform my own research? I am not a doctor.

Answer:
You do not have to be a doctor to understand prostate cancer. Learning about cures is easy. Here are things you should do:

(a) When speaking to your urologist or radiation oncologist, always ask these four key questions:

How many men with prostate cancer have you personally treated?
Do you have a computerized database of all the men you have treated?
Of the men you have treated, how many have PSA 0.2 ng/ml 10 years after treatment?
If you were to treat my particular case of prostate cancer, what is my 10-year Individual Cure Rate?

(b) Get a second opinion from both urologists and radiation oncologists.
(c) Perform an Internet search for “prostate cancer” and “prostate cancer treatment” on Google™, Yahoo™ or other search engines.
(d) Speak with friends and neighbors who have been treated for prostate cancer.
(e) Read medical research papers from peer-reviewed medical journals.
(f) Study this website.

Evaluating Your Cancer

--Prostate Specific Antigen, PSA--

Question 3:

Help me understand my own cancer. My PSA is 6.3 ng/ml, but what is PSA?

Answer:
PSA is an enzyme that is produced only by prostate cells, both normal and cancerous, and secreted into the semen to keep it liquefied. Additionally, a small amount of PSA is continually leaked into the blood stream by prostate cells. The PSA in the blood is measured by the PSA test.

Question 4:
How much PSA is produced by a normal prostate?

Answer:
The amount of PSA is generally related to prostate size, and the prostate typically enlarges as men age. Overall, a PSA level of up to 4.0 ng/ml is considered normal for men older than 60, and 2.5 ng/ml is the upper normal range for men age 60 or younger. These are rough guidelines because some younger men will have enlarged prostates and some older men will have normal-sized glands. Furthermore, prostate cancer can occur with PSA less than 2.5 ng/ml.

Question 5:
How much PSA is produced by prostate cancer?

Answer:
Prostate cancer cells leak a lot more PSA into the blood stream. On average, one prostate cancer cell will produce 10 times more PSA than one normal prostate cell. Consequently, a man with prostate cancer will usually, but not always, have a PSA level above 4.0 ng/ml or 2.5 ng/ml for men age 60 or younger.

Question 6:
What is the average PSA level of men with prostate cancer?

Answer:
The average PSA level is 7.2 ng/ml, but there is a wide variation. We have treated men for prostate cancer with a PSA as high as 430 ng/ml and as low as 0.3 ng/ml.

Question 7:
If a man has prostate cancer, does the amount of PSA measure how much cancer he has?

Answer:

The amount of PSA is our best measurement for the amount of prostate cancer in a man. For example, a man with 100 prostate cancer cells would typically have a higher PSA than a man with 10 cancer cells. Based on a man’s PSA level, we classify men with prostate cancer into four PSA groups, shown in Table 2.

Question 8:
Does the PSA level always measure the amount of prostate cancer?

Answer:
Unfortunately, no. Some prostate cancers make very little PSA and are called low-PSA producing cancers. Often, these are men with high Gleason scores indicating more aggressive cancers. Low-PSA producing cancers can be advanced and fool doctors. We discover low-PSA producing cancer based on digital rectal examination through palpation of a cancer. Additionally, these cancers can be discovered by measuring PSA velocity. Even though a man’s PSA may be within normal limits, if the PSA is progressively rising, for example 0.5 ng/ml to 1.0 ng/ml to 1.8 ng/ml in less than a year, this rise should alert doctors to the possibility of prostate cancer.

Question 9:
Is PSA produced only by prostate cancer cells located in the prostate?

Answer:
No. This is a common misconception. Prostate cancer cells found in any place in a man’s body produce PSA whether they are located in bone, lung, prostate, lymph nodes or any other area. A prostate cancer cell in a man’s left shoulder makes the same amount of PSA as one in his prostate. For this reason, a PSA test checks for prostate cancer throughout a man’s body, but PSA gives no information about where the cancer cells are located.

Question 10:
Do all men with a PSA above normal levels have prostate cancer?

Answer:
No. Another cause for PSA elevation is a prostate disease called benign prostate hyperplasia (BPH) or enlarged prostate. BPH is the most common prostate disease in men and is present in half of men age 60 or older. BPH, not cancer, is the reason men have difficulty with urination, such as a weak, slow urine stream because the urethra tube is squeezed by the enlarged prostate. Inflammation of the prostate, called prostatitis, can also cause elevated PSA levels.

--Stage--

Question 11:
My cancer stage is T1c. What is cancer stage?

Answer:
Clinical stage of cancer is determined by physical examination of the prostate called a digital rectal examination (DRE). The eight different stages are in Table 3:

Question: 12:
How accurate is staging of prostate cancer?

Answer:
The purpose of staging is to locate the cancer, but this is often inaccurate. In fact, compared to the PSA and Gleason score, staging of prostate cancer is the most inaccurate measure of the extent of your cancer. The biggest area of inaccuracy concerns stages T1 and T2 disease, the stages that most men have. In reality, one-third or more of men with stage T1 or T2 prostate cancer actually have stage T3 prostate cancer, cancer outside the prostate due to microscopic capsule penetration of cancer cells, which cannot be detected before treatment. For more information on microscopic capsule penetration, refer to Questions 32 – 41.

--Prostate Biopsy Pathology Report--

Question 13:
Why is a prostate biopsy pathology report important?

Answer:
Your prostate biopsy pathology report is the key to understanding your particular case of prostate cancer. It is far more important than PSA, stage, bone scans or anything else. The information in the pathology report tells doctors how fast your cancer is growing, how extensive it is within the prostate, and the likelihood of capsule penetration (leakage of cancer cells outside the prostate). The pathology report is the cornerstone to tailoring treatment to the extent and aggressiveness of your prostate cancer, as well as to the calculation of your 10-year Individual Cure Rate (ICR).

Question 14:
What’s a prostate biopsy pathology report? (See Figure 1 and Table 4.)

Answer:
As noted in Question 1, when your physician found your PSA of 6.3 ng/ml, you were referred to a urologist. Your urologist performed a prostate biopsy, which is an outpatient office procedure in which 12 small needles were inserted into your prostate and tiny cores of tissue were removed from all areas of the gland.^16,17 The prostate is divided into halves and needles were inserted into the top (base), middle and bottom (apex) of each half of the prostate. Two biopsies were obtained from each of these six areas, the medial and the lateral (inside and outside). Each of the needle cores should be placed in a separate container and labeled by its location within the prostate. All of the prostate cores were sent to a pathologist who processed the material and examined the biopsy needle cores under a microscope. The pathologist’s findings were described in a written report called the prostate biopsy pathology report. You should get a copy of your biopsy report from your urologist and carefully study it.

Question 15:
What does a prostate biopsy pathology report look like? (See Table 4.)

Answer:
A copy of an RCOG Second Opinion Prostate Biopsy Pathology Report is shown in Table 4. Do not be alarmed if this report seems too complicated; it was written for doctors who specialize in prostate cancer. However, you can easily learn the basic points of this report. Learning the basic points is critical, because the pathology report is the key to a man’s particular case of prostate cancer. This report was written by our consulting pathologists, Dr. Aileen O’Neill, Dr. Joanne Piratzky and Dr. Charles Andrews. They have been reviewing outside biopsies and writing Second Opinion Prostate Biopsy Pathology Reports for RCOG for 15 years.

Question 16:
Please explain the pathology report. (See Table 4.)

Answer:

The urologist inserted 12 needles into this man’s prostate, and each was labeled according to needle location within the prostate. See Figure The needles were evaluated by our consulting pathologist.^17,18 A written report was made, which is Table 4. Needle core #1 was taken from the medial side of the base of the right half of the prostate (the inner right half of the prostate at the top) and showed no cancer. Needle core #2 also had no cancer; however, needle cores 3-7 and 9-12 had cancer. Altogether, of the 12 biopsy needle cores from this man’s prostate, 10 had cancer of different Gleason scores. This is important information because the overall percent of positive needle cores (in this case 83%) is directly related to the best treatment for this man and his chance of cure.¹⁷More needle cores with cancer means more extensive cancer.

Question 17:
What is Gleason score? (See Table 5.)

Answer:
Gleason score predicts how fast your cancer is growing.¹⁹ It is the most important measurement in a pathology report. Gleason score consists of two numbers called grades, which range from 1–5. Grade 1 indicates slow growth, and grade 5 is a rapidly growing cancer. The predominant grade seen in a needle core is the first number of the Gleason score. The second number is the next most common grade. In needle core #3 of Table 4, the most common grade is grade 3 and the next most common is grade 4 (40%), which indicates a total Gleason score of 7. In contrast, needle core #5 primarily has grade 4 (70%) and, thus, 30% in grade 3. The cancer in needle core #5 is more aggressive than the cancer in core #3 because it has more grade 4. Men are classified by their highest Gleason score, which in this case is Gleason score 8 (needle cores #7 and #9).¹⁸

Question 18:
What does needle core length mean? (See Figure 1 and Table 4.)

Answer:
This measurement is the total length of the needle core. For example, needle core #3 was 16mm long, which means that a core of prostate 16mm long was removed from this man’s prostate.

Question 19:
What does cancer length mean? (See Table 4.)

Answer:
This is a measurement of the length of the cancer in the needle core. Of the 16mm of core #3, 4mm was cancer.

Question 20:
What does TLTL/CSLCSLCSL ratio mean? (See Table 4.)

Answer:
This is the percent of cancer in the needle core. Four mm, or 25%, was cancer in the 16mm core #3. A higher percentage cancer in a core lowers the chance of cure.²⁰

Question 21:
What does percent grade 4 or 5 mean? (See Table 4.)

Answer:
This shows the percentage of grade 4 or 5, which are the most aggressive grades of prostate cancer. The percent grade 4 in core #3 was 40% (thus, 60% was grade 3). This is an important measurement because an increasing percent of grade 4 or 5 indicates a more aggressive cancer with an increased chance of additional cancer cell leakage outside the prostate and reduces the chance of cure.²¹ The amount of grade 4 or 5 you have greatly impacts how you should be treated, as well as your chance of cure.

Question 22:
What does perineural invasion mean? (See Figure 2 and Table 4.)

Answer:
The finding of perineural (meaning “around the nerve”) invasion, as in core #5, helps identify a greater chance of cancer cell leakage through the capsule to outside the prostate (called microscopic capsule penetration) and a lower cure rate.^22,23,24,25 A man has two sex nerves. One runs along the right side of the prostate, and the other along the left. Branching off these two large nerves are many smaller nerves that go through the prostate capsule (which surrounds the prostate like a shell around an egg) and enter the prostate. The smaller nerves have a space around them called the perineural space. Cancer cells in the prostate can get in the perineural space and use it as a “tunnel” to travel and escape through the capsule and grow and spread outside the prostate.^26,27 Perineural invasion was found in two needle cores in this man – core #5 and #11.

Biopsy Pathology Report

Question 23:
What is a Second Opinion Prostate Biopsy Pathology Report from RCOG? (See Table 4.)

Answer:
When a man has a consultation at RCOG, we ask the pathologist who originally examined his biopsy material to send us the needle cores removed from the prostate by his urologist. We then send the cores to Dr. O’Neill and her group to review them by taking a second look at the cores using their microscope and provide us a written second opinion of their review. Table 4 is a review for a patient. We will not treat a patient at RCOG until we have the biopsy material reviewed and have obtained your Second Opinion Prostate Biopsy Pathology Report.

Question 24:
Why do you get a second opinion of the biopsy cores?

Answer:
We want to double-check your biopsy cores. An accurate interpretation of your biopsy cores correlated with our computerized database is the key to deciding which treatment technique to use as well as to accurately calculate your 10-year Individual Cure Rate (ICR).

Question 25:
Do you find differences between the second opinion report by Dr. O’Neill and her group and the original outside pathology report?

Answer:
Yes. In 90% of cases, we get more information from the second opinion report than from the original report. Most outside pathology reports have no information about perineural invasion, the percentage of grades 4 or 5 in each needle core or the percentage of cancer in each needle. We also find that 25% of men have the Gleason score in the outside report changed to a new Gleason score in the Second Opinion Prostate Biopsy Pathology Report.²⁸ Since we tailor treatment and calculate your 10-year ICR primarily according to the pathology report findings, we want as much information from the pathologist as possible, and we want it to be accurate.

Question 26:
Can any man with prostate cancer get a Second Opinion Prostate Biopsy Pathology Report from Dr. O’Neill’s group?

Answer:
Yes. All you need to do is give us your permission to review your biopsy cores. We will get your prostate biopsy slides from your original pathologist and send the material to Dr. O’Neill. Within five days, we will receive the Second Opinion Prostate Biopsy Pathology Report from Dr. O’Neill’s office and send the results to you. You can also send RCOG your PSA and the stage of your prostate cancer, and we will calculate a 10-year ICR graph for you using the second opinion report. Then, we will mail your 10-year ICR graph and Second Opinion Prostate Biopsy Pathology Report to you. You can call RCOG for details on how to send this material. If you do not understand and would like to discuss your Second Opinion Prostate Pathology Report, you can talk to any RCOG doctor, or we can put you in contact with Dr. O’Neill, Dr. Piratzky or Dr. Andrews. Click here to contact us for your 10-year ICR.

Question 27:
Should I be treated for my prostate cancer quickly? Do I have time to get a second opinion of my pathology report and a 10-year ICR from different doctors?

Answer:
The worst thing you can do is make a hasty decision, be treated and later learn that another treatment or doctor was better for you. Prostate cancer is generally a slow growing disease, so you can take several weeks to decide what to do. In fact, some men manage this disease with “watchful waiting.” However, if you do have an aggressive cancer, such as Gleason score 4+3 or higher, you might want to make a decision on treatment within two months of diagnosis.

Question 28:
If my urologist did not perform the prostate biopsy correctly or the pathologist did not interpret my biopsy cores accurately, should I have a repeat prostate biopsy?

Answer:
A repeat prostate biopsy is rarely needed. Our consultant pathologists almost always give us the necessary information from the original biopsy cores to plan treatment and predict cure.

Curing Prostate Cancer

--The Normal Prostate and How Prostate Cancer Works--

Question 29:
Tell me about a normal prostate gland. (See Figure 3.)

Answer:
The prostate is located behind the pubic bones in a man’s pelvis and is sandwiched between the bladder on top and the rectum underneath (see Figure 3). A normal-sized prostate is about the size of a walnut. Similar to a shell around an egg, a capsule covers and contains the prostate except at the apex (bottom). The tube called the urethra, which empties the bladder, runs through the middle of the prostate and out of the penis for urination. Very small tubes, the ejaculatory ducts, run from each testicle into the prostate and empty into the urethra in the middle of the gland. Two sex nerves for erection of the penis are adjacent to both the right and left sides of the prostate. About two-thirds of the prostate are normal prostate cells, and the remaining part is the urethra, muscles that act like valves to prevent leakage of urination, fibrous tissue that holds the prostate together, blood vessels and the ejaculatory ducts. The purpose of normal prostate cells is to produce seminal fluid, which when mixed with the sperm from the testicles, is called semen – the white-colored fluid visible upon ejaculation. Prostate cells also secrete various proteins into the blood stream, one of which is called Prostate Specific Antigen (PSA).

Question 30:
What causes prostate cancer?

Answer:
No one really knows. We do know, however, that the chance of developing prostate cancer increases as a man ages and that it is rare in men younger than 40 years old. Probable cause is related to a man’s environment and diet. For example, men from Western industrialized countries have a higher incidence of prostate cancer than men from Asia. African-American men have a higher incidence of more aggressive prostate cancer than Caucasian men. Additionally, the incidence of prostate cancer is significantly increased in men who have a family history of this disease, meaning their father, brother, uncles or grandfather had prostate cancer.

Question 31:
How does prostate cancer work? (See Figure 4.)

Answer:
There are three basic steps in the growth of prostate cancer. The first step is the development of prostate cancer and growth inside the prostate gland. For reasons we do not understand, one or more normal prostate cells transform into prostate cancer cells and begin to grow. The hallmark of any cancer is cancer cell growth – reproduction, or making more cancer cells. For a long period of time, prostate cancer grows only inside the prostate and is contained by the capsule that surrounds the prostate. Eventually, the second step occurs – cancer cell leakage through the capsule outside the prostate, which is officially called microscopic capsule penetration. Depending upon the treatment method, prostate cancer can still be cured in either Step 1 or Step 2. If left alone, Step 3 will eventually occur. The third step is the spread of prostate cancer (metastasis) beyond the area of the prostate such as lymph nodes, bones, lungs or any other place in the body. Step 3 is incurable prostate cancer.

Question 32:
Please explain more about microscopic capsule penetration – step 2 of cancer growth. (See Figure 5.)

Answer:
Microscopic capsule penetration is one of the most important concepts to understand about prostate cancer and has been extensively studied at Johns Hopkins University.²⁹ Prior to surgery (radical prostatectomy), between the years 2000 and 2005, a group of 5,730 men had a prostate biopsy, PSA and were staged either T1 or T2 based on DRE (digital rectal exam). Surgical removal of the prostate was performed on these men, and the entire prostate was given to the pathologist for microscopic examination to determine, among other things, if cancer cells had leaked through the capsule and were outside the prostate, which means that men were really stage T3. The chance of cancer cell leakage was then correlated with Gleason score, stage and PSA in the Partin tables.²⁹ The chance of microscopic capsule penetration ranged from 7% to 89%. Microscopic capsule penetration is important to understand because it will determine your chance of cure. However, it is impossible to know whether or not you have microscopic capsule penetration before any treatment. Cancer cell leakage through the capsule cannot be detected before treatment because the DRE, prostate biopsies, CAT scans or MRI scans cannot detect cancer that can ONLY be found with a microscope.

Question 33:
How do cancer cells leak through the capsule and outside the prostate? (See Figure 6.)

Answer:
Cancer cell leakage can occur in four basic ways. The first way is through development of cancer adjacent to the capsule with the cancer simply destroying the capsule (eating a hole in the capsule) and leaking out. A second way is through perineural invasion, which means cancer cells travel along branches of the sex nerve and “tunnel” through the capsule to escape the prostate (see Question 22). The third method of microscopic capsule penetration occurs at the bottom (apex) of the prostate because the prostate capsule thins out and does not exist in this location, which makes it easy for cancer cells to escape the prostate in this area. Check your pathology report to see if you have cancer at the apex because this is the most common place for positive surgical margins, meaning cancer cells cut across and left behind after radical prostatectomy. (See Questions 86, 87 and 96). The fourth method is invasion into the seminal vesicles, which are attached to the top of the prostate.

--Cure: An Undetectable PSA (PSA 0.2 ng/ml) and Microscopic Capsule Penetration--

Question 34:
How do you determine if someone is cured of prostate cancer? (See Figure 7.)

Answer:
To be cured of prostate cancer, any treatment must destroy all the prostate cancer cells, which is possible if your cancer is located only inside the prostate contained by the capsule (Step 1) or if you have microscopic capsule penetration through the capsule (Step 2). We also want to destroy all the normal prostate cells to prevent you from getting another cancer. Cure, both destruction of all your prostate cancer cells and normal prostate cells, is determined by using the PSA test. As mentioned, the PSA test is used to find prostate cancer. An equally important use of the PSA test is to find out if men are cured of prostate cancer. To be cured of prostate cancer, your PSA must fall to an undetectable level after treatment and remain there forever.

Question 35:
What number is an undetectable PSA? (See Figure 7.)

Answer:
An undetectable PSA is PSA 0.2 ng/ml or lower, which essentially means a “zero” PSA. PSA 0.2 ng/ml means undetectable because PSA tests are unreliable below 0.2 ng/ml. Thus, to be cured of prostate cancer using any treatment, your PSA must fall to 0.2 ng/ml or lower and remain at 0.2 ng/ml or lower forever. This PSA definition is based on medical studies of the PSA found in men cured of prostate cancer after radical prostatectomy and ProstRcision.^1,5,6

PSA 0.2 ng/ml: the only definition of cure

Question 36:
What is the connection between PSA 0.2 ng/ml and cancer localized in the prostate? (See Figure 8.)

Answer:
The best way to understand this connection is to discuss treatment with radical prostatectomy or surgical removal of the prostate, which is where we first learned about both of these issues. Let’s assume you have 100 prostate cancer cells, all 100 are contained by the capsule inside the prostate and you have no microscopic capsule penetration (this is Step 1 in cancer cell growth). If you had a radical prostatectomy, the entire prostate would be cut out. Consequently, all your normal prostate cells, as well as the 100 prostate cancer cells, would be removed. Because you would no longer have any prostate cells in your body to make PSA, your PSA would fall to an undetectable level (PSA 0.2 ng/ml). PSA 0.2 ng/ml after your radical prostatectomy would mean that you had been potentially cured of prostate cancer.

Question 37:
If my PSA were to be 0.2 ng/ml or lower after radical prostatectomy, why am I only considered “potentially cured” instead of cured? (See Figure 9.)

Answer:
This is because you must not only achieve PSA 0.2 ng/ml, but your PSA must stay undetectable forever. To illustrate this point, let’s assume you have 100 prostate cancer cells and were stage T1c before radical prostatectomy, which means, as far as we know, all your 100 prostate cancer cells were contained inside the prostate by the capsule prior to your surgery. However, since microscopic capsule penetration CANNOT be detected before any treatment, including surgery, let’s realistically assume that of your 100 prostate cancer cells, 95 are actually inside the prostate and five cancer cells penetrated the capsule and leaked into the area surrounding the prostate, which includes the rectum, bladder, sex nerves and muscles that control urination. With a radical prostatectomy, your prostate would be removed along with all normal prostate cells and the 95 cancer cells inside the prostate. Some of the five cancer cells that leaked out of the prostate would also be removed, but typically not all of these cancer cells can be cut out since they are around your normal adjacent organs. Doctors are not going to cut out your rectum or bladder, nor do they want to cut out the muscles that control urination or the sex nerves (where microscopic cancer cells can leak through the perineural space). Let’s assume that four of the five cancer cells that leaked out of the prostate are removed at surgery, but one cancer cell was left behind. This single cancer cell would not make enough PSA to be detectable. Consequently, your PSA after surgery would be PSA 0.2 ng/ml; however, you still have one cancer cell and would not be cured.

Cancer cell leakage over time leads to rising PSA levels

Question 38:
What would happen with the one cancer cell left behind? (See Figure 9.)

Answer:
Over time, this one cancer cell would multiply and make more cancer cells. Eventually, the increasing number of cancer cells would produce enough PSA to make your PSA level rise above 0.2 ng/ml.¹ Any rise in PSA above 0.2 ng/ml after radical prostatectomy guarantees that you were not cured. Your cancer is regrowing because the only other cells that make PSA are normal prostate cells, but they were all removed during surgery.

Question 39:
Is that what you mean when you say to be cured of prostate cancer, my PSA has to stay at 0.2 ng/ml forever?

Answer:
Yes. Remember, there are two PSA steps to cure: 1) you must achieve PSA 0.2 ng/ml, 2) you must stay at 0.2 ng/ml forever. From a practical standpoint, almost all prostate cancer that is going to grow back will do so within 10 years of treatment.

Question 40:
What would it mean if I had surgery and my PSA nadir was above 0.2 ng/ml, for example 0.6 ng/ml? (See Figure 10.)

Answer:
After radical prostatectomy, a PSA above 0.2 ng/ml guarantees that you have not been cured. Let’s revisit our example of 100 cancer cells. This time, let’s assume 90 cancer cells are inside the pr

Failure to destroy all cancer cells causes PSA to rise over time

ostate and 10 are microscopic capsule penetration cancer cells. With surgery, the 90 cancer cells in the prostate would be removed, plus all normal prostate cells. Now, let’s assume seven out of the 10 leaked cancer cells are removed, for a total of 97 of the 100 cancer cells (three cancer cells were left behind). Let’s also assume that these three cancer cells produce a total PSA of 0.6 ng/ml. Therefore, when you remove the normal prostate and the 97 cancer cells, your PSA would fall, but the three leaked cancer cells left would produce 0.6 ng/ml. In this instance, you did not achieve PSA 0.2 ng/ml, which means you still have cancer.

Question 41:
Why is it important that I learn about PSA 0.2 ng/ml?

Answer:
Because the cornerstone to understanding treatment and cure of prostate cancer is this: after any treatment, your PSA must fall to PSA 0.2 ng/ml or lower and remain at 0.2 ng/ml forever. A PSA of 0.3 ng/ml or more, or a later rise above 0.2 ng/ml, means you have not been cured.

Individual Cure Rate

Question 42:
What does cure rate mean?

Answer:
Cure rate refers to the percentage of all men treated for prostate cancer who have an undetectable PSA (PSA 0.2 ng/ml or lower) after 10 years. For example, a cure rate of 64% means that if 100 men are treated, 64 have PSA 0.2 ng/ml or lower after 10 years, which is the standard calculation time.

Question 43:
Why is 10 years following treatment the standard time to calculate cure rates for prostate cancer?

Answer:
This is the standard because almost all men who are not cured will have regrowth of their prostate cancer within 10 years of treatment or they will not achieve an undetectable PSA. Their PSA will fall to 0.2 ng/ml and later rise above 0.2 ng/ml. (See Figure 8). Recurrences are rare more than 10 years after treatment.³⁰ Thus, the percentage of men with a PSA 0.2 ng/ml 10 years after treatment is the standard time to measure cure rate for any treatment. Cure rates are displayed in 10-year graphs.

Question 44:
What does a graph of a cure rate look like? (See Figure 11.)

Answer:
A graph showing the cure rate of men, ranging from early to advanced prostate cancer and treated at RCOG with ProstRcision, is given in Figure 11. The vertical line on the left-hand side of the graph is the percentage of men free of cancer after treatment with ProstRcision. The horizontal line at the bottom of the graph is the time, in years, following treatment. The line at the top, which intermittently drops and shows 87% five years after treatment and 83% at 10 years, is the cure rate calculated with the Kaplan-Meier method. This means that for every 100 men treated with ProstRcision at RCOG, 87 had PSA 0.2 ng/ml five years after treatment, but a few more men had recurrence after five years, which leaves 83 with PSA 0.2 ng/ml or lower 10 years after treatment. Also note that the curve flattens after eight years, which indicates few recurrences after this time. Thus, the overall 10-year cure rate is 83%. See Table 1.

Question 45:
What is a 10-year Individual Cure Rate or ICR?

Answer:
The overall cure rate curve shown in Figure 11 is for all men treated at RCOG, regardless of their PSA or prostate biopsy pathology report findings. A 10-year ICR is the cure rate graph for only one of these men (an individual). For your own case of cancer, you do not want to look at the overall 10-year cure rate graph; instead, you want to see the cure rate graph for your particular case of prostate cancer. This is extremely important because prostate cancer varies from one man to another. Consequently, cure rates vary widely from one man to another, from 7% to 99%, all of which depends on the extent and aggressiveness of your prostate cancer.

Question 46:
Explain how you’d calculate my 10-year Individual Cure Rate. (See Figure 12.)

Answer:
We’d use our database, which is comprised of the 12,000 men we have treated with ProstRcision. For all 12,000 men, we receive a PSA every six months after treatment, and we have data on patients that goes back more than 25 years. We’d analyze the after-treatment PSA levels only of those men who match your pretreatment medical findings and calculate the percentage with PSA 0.2 ng/ml 10 years after ProstRcision. For greater accuracy, instead of using only PSA, Gleason score and stage, we’d match your six cancer findings mentioned in Question 1 with all previously treated men in our database who have similar medical findings. These cancer findings are:

1.) PSA 6.3
2.) Stage: T1c
3.) Gleason score: 6
4.) Cores with cancer 1 of 12
5.) Percent cancer in core: 10%
6.) Perineural invasion: No

Your 10-year ICR graph is shown in Figure 12. This means that if we treat you with ProstRcision, your chance of cure (PSA 0.2 ng/ml or lower 10 years later) will be 97%.

Question 47:
Can you give me another example of a 10-year ICR but with a more advanced case of prostate cancer? (See Figure 13.)

Answer:
Let’s assume your PSA is still 6.3
ng/ml and you have Stage T1c disease, but your prostate biopsy report shows you have Gleason score 4+3=7, involving three of 12 needle cores, 40–70% cancer in the three 4+3=7 cores and 60–70% Gleason grade 4 in the involved cores, plus perineural invasion. Again, we matched these prostate cancer findings to all previously treated men in the RCOG database who had similar findings. The 10-year ICR for this particular case of prostate cancer would be 71%, as shown in Figure 13. As you can see from these two examples, a 10-year ICR can vary from one man to another and depends upon the extent and aggressiveness of his particular case of prostate cancer.

Question 48:
Why is a man’s 10-year ICR important?

Answer:
Your goal is to be cured of prostate cancer. A 10-year ICR provides you with a precise chance of being cured by a given doctor using a particular method of treatment. A 10-year ICR is the single most important piece of information you can get from your urologist or radiation oncologist.

Question 49:
What can I do with my 10-year ICR from RCOG?

Answer:
Compare it with your 10-year ICR from other doctors. Ask your urologist for a copy of your 10-year ICR if he were to perform a radical prostatectomy on you. You can also explore the other eight treatment methods listed in Table 1 by asking other doctors for their 10-year ICR if they were to treat you. Then, you and your family can compare the 10-year ICRs from each doctor for your particular case of prostate cancer and make an objective decision about which treatment method and doctor gives you the best chance of cure. The 10-year ICR should determine the best treatment and doctor for your case of prostate cancer.

Question 50:
How can a man with prostate cancer get a 10-year ICR from RCOG?

Answer:
Send a copy of your PSA, stage, prostate biopsy pathology report and other medical records to us. We will match your findings to men with similar medical records from our database and calculate your 10-year ICR. These 10-year ICR calculations will be done at no charge, and your 10-year ICR graph will be mailed to you so that you will have your precise chance of being cured by ProstRcision in writing. Contact Us for more information on how to receive your ICR.

Question 51:
Will the 10-year ICR for my case of prostate cancer vary with the 10 treatment methods listed in Table 1?

Answer:
Yes. Each of the 10 treatment methods will usually produce a different 10-year ICR for your particular case of prostate cancer. Additionally, the 10-year ICR will vary from doctor to doctor, even though he may perform the same treatment. For example, medical studies have documented that the cure rates of urologists who perform radical prostatectomy will vary from one doctor to another depending on their skill levels.³¹ The same will apply to doctors who perform seed implants, cryosurgery or IMRT only. This makes common sense. Ask yourself: Do all golfers have the same skill level? The obvious answer is no. There is an elite group of golfers, such as Tiger Woods, Phil Mickelson and others on the pro circuit who are far better than the average golfer in the United States. The same observation applies to doctors. This is why you should do your own research and focus on a doctor’s 10-year ICR for you.

Question 52:
Is there any difference among ICRs for the doctors at RCOG who perform implants?

Answer:
No. Overall ICRs are calculated for each of the RCOG doctors, and the results are compared. These results indicate that there is no difference among the ICRs of RCOG doctors.

Question 53:
Can my urologist or radiation oncologist give me a 10-year ICR?

Answer:
Yes. He should be able to give you a 10-year ICR graph for your case of cancer if your doctor follows all his patients after treatment. A doctor must have a database to calculate a 10-year ICR for you. A database should have at least 2,000 men in it, and a substantial number of these men should have more than 10 years of follow-up. However, according to men we have treated, urologists and radiation oncologists who treat prostate cancer rarely follow their patients after treatment and do not have a database.

Question 54:
If urologists and radiation oncologists do not track or follow-up with the men they treat and do not have a database, how do they know if they are curing prostate cancer?

Answer:
Unfortunately, they don’t know. Most doctors basically tell men, “Trust me” and guess at a cure rate. This is something that you should be aware of and why you must carefully question doctors, using the four questions mentioned in Question 2.

Question 55:
Is this why doctors will not talk about their cure rates with men?

Answer:
Yes. Urologists and radiation oncologists talk almost exclusively about treatment — radical prostatectomy, beam radiation with IMRT, seed implantation, etc. They rarely talk about their own cure rates because they do not have a cancer database, which means they cannot calculate cure rates.

Question 56:
What is a prostate cancer database?

Answer:
A prostate cancer database is a collection of information about all men previously treated by a doctor for prostate cancer using any of the 10 treatment methods listed in Table 1. For example, at RCOG, we have treated 12,000 men with prostate cancer using ProstRcision during the past 30 years. Before treatment, data is entered for each patient such as PSA, age, prostate biopsy pathology report findings, etc. The second set of information concerns the treatment technique, which includes the number of seeds, radiation dose from the seeds, as well as the subsequent IMRT beam radiation for each patient — all of this is also entered. Then, every six months after treatment, PSA data, urinary and rectal symptoms, and other information is entered into the computer for each of the 12,000 men. This information is entered year after year. We currently have 25 years of data. For more information, contact us to receive the RCOG Computerized Database brochure.

Question 57:
How important is a doctor’s database to men with prostate cancer?

Answer:
A database is the foundation of any urologist’s or radiation oncologist’s practice. The importance of a database to a man with prostate cancer can be summarized by these questions:

How does a doctor know how many men he cures of prostate cancer? Unless the doctor keeps up with all men he has treated and enters this information into a database, a doctor cannot calculate his own cure rates.
How can a doctor improve his treatment technique and cure rates? With a database, a doctor can examine how he has treated men, compare cure rates and refine his technique accordingly. Without a database, the doctor cannot make any improvements.
Since prostate cancer varies from patient to patient, how can a doctor vary his treatment according to the extent of a man’s cancer? Depending upon how aggressive and how extensive it is, using RCOG’s database, treatment is tailored to each man’s disease. Unfortunately, a doctor cannot tailor treatment to a particular case without a database.
How can a urologist or radiation oncologist calculate an ICR graph for men newly diagnosed with prostate cancer? The doctor cannot unless he has a database. A database is the key to the management of prostate cancer by any urologist or radiation oncologist.

Question 58:
My urologist does not follow his patients and does not have a database. He has recommended robotic radical prostatectomy. What should I do?

Answer:
Men often face this situation. Again, ask yourself, “Why do I want to be treated?” Your answer is, “To be cured.” We will give you a graph of your 10-year Individual Cure Rate with ProstRcision. Ask your urologist for your 10-year ICR graph with radical prostatectomy. If he will not or cannot give you a 10-year ICR graph, you must decide whether you want a proven cure rate with ProstRcision for your own particular case of prostate cancer or if you want to blindly trust your urologist and let him perform surgery on you. Without a 10-year ICR graph, you do not know if radical prostatectomy is the best treatment for you, nor do you know how well your urologist cures prostate cancer with radical prostatectomy. Since you will typically get only one chance for cure, you should ask yourself this question, do I want to gamble with my ONE chance for cure or do I want a proven cure rate?

ProstRcision^®

Question 59:
What treatment is given at RCOG?

Answer:
We provide a treatment method called ProstRcision, which was developed at RCOG. ProstRcision (pronounced PROS-ter-si-shun) means destruction (excision) of prostate cells, normal and cancerous, with irradiation instead of with a knife (surgery). In other words, we kill all normal and cancerous prostate cells with ProstRcision, but, in contrast to radical prostatectomy, ProstRcision leaves behind the sex nerves and muscles that control urination. ProstRcision is based on the integration of two separate methods of irradiation in an attempt to get the best cure rate possible with the least complications. The two methods of irradiation are:

Radioactive iodine (I-125) prostate seed implant, followed by,
Linear accelerator irradiation using either the conformal beam or intensity modulated radiotherapy technique (IMRT).

Question 60:
What is an I-125 seed?

Answer:

A radioactive I-125 seed has radioactive iodine (125) attached to a very tiny bar of silver, all of which is placed in a small titanium capsule that is 1/5–inch long (4.5 mm) and 1 mm wide. Each seed produces a tremendous amount of low energy gamma radiation (28 KEV) within 2 – 4 mm of the seed, but then radiation drops off rapidly. Thus, each seed will irradiate an area about the size of a very small marble. Each radioactive I-125 seed slowly gives off clinical radiation for about one year and then is effectively “dead.” However, the silver bar and the titanium capsule will remain in the prostate forever.

Question 61:
What is an I-125 prostate seed implant? (See Figure 14.)

Answer:
A prostate seed implant is a minor surgical procedure, performed in an outpatient surgical center by a team of a urologist and radiation oncologist. After the patient is placed under general anesthesia, his legs are placed in stirrups and an ultrasound probe, which is connected to a television monitor, is inserted into the rectum. While watching the prostate on the television monitor, an average of 21 hollow, 8-inch long needles are inserted through the perineum (the area located between the anus and the testicles) into the prostate. Some needles are inserted into the seminal vesicles (an organ attached to the top of the prostate). Needle insertions are performed by a urologist while discussing the needle position with the radiation oncologist. The entire prostate seed implant takes 35-45 minutes to perform.

Question 62:
What happens after needle insertion?
(See Figure 14.)

Answer:
The radiation oncologist inserts a cartridge of I-125 seeds into a seed implant device. Then, he attaches the seed implant device to one of the needles and injects a seed out of the end of the 8-inch long needle starting at the top of the prostate. After injection of the first seed, the needle is pulled back and another seed is injected. Seeds are continually injected until reaching the bottom of the prostate, after which the needle is pulled out of the patient. The radiation oncologist then goes to the next needle and repeats the same process until seeds have been injected through all needles. A different number of seeds are injected through each needle, depending on where the needle is located within the prostate. Additionally, seeds are injected into the seminal vesicles. Seeds are typically placed closer together to increase the amount of radiation in the prostate sections that have cancer, especially if there is a large amount of cancer or if the cancer is Gleason score 3+4 or higher. Thus, a radiation doctor can vary the amount of radiation within the prostate based on where the cancer is actually located, while covering all of the prostate with a low dose of radiation to destroy any cancer that may have been missed at biopsy, as well as to destroy all normal prostate cells to prevent the patient from getting a new cancer.

Question 63:
What happens next?

Answer:
After all seeds are inserted and all needles are removed, a cystoscope examination is performed by the urologist. To perform this procedure, the urologist inserts a tube, similar to a submarine periscope, through the urethra, which enables him to look inside the prostate and inside the bladder to check on these organs. After the cystoscope exam, a urinary catheter is inserted through the urethra into the bladder, and the patient is sent to the recovery room. After one to two hours, and when he is fully awake, the patient goes home. The patient can then eat, drink or do anything he wishes.

Question 64:
Following the procedure, when does the patient see a doctor?

Answer:
The morning after the seed implant, the patient returns to RCOG, and the urinary catheter is removed. X-rays and CAT scans of the seeds are made and shown to the patient, and questions are answered. The patient may resume normal activities the day after the implant, which include eating a normal diet, playing golf, going to the gym, as well as sexual activity. The only medication required is antibiotics. This is not a painful procedure, and pain medication is rarely required.

Question 65:
How many seeds are injected at each prostate I-125 seed implant?

Answer:
An average of 74 seeds, but this can range from 45 to 230. Each implant is tailored for each prostate cancer patient depending on the size and shape of his prostate, location, aggressiveness and extent of the cancer based on the prostate biopsy pathology report as well as any pre-existing bladder or rectal problems.

Question 66:
The radiation from the seeds helps destroy the cancer cells and normal prostate cells inside the prostate. Do the seeds have any other use?

Answer:
Yes. The seeds have another very important function — they serve as a TARGET for the subsequent beam radiation since the seeds are actually tiny pieces of metal. To understand this you should know that the prostate is not visible on X-rays. However, by placing an average of 74 metal seeds throughout the prostate, you can “see” the prostate outlined by these pieces of metal. To see the prostate even better, we inject three non-radioactive gold seeds during the seed implant. The combination of the silver in the iodine seeds and the gold seeds serves as a perfect target for precise IMRT beam radiation later delivered with the linear accelerator.

Question 67:
How long do you wait after the prostate seed implant before starting the follow-up IMRT beam radiation?

Answer:
The IMRT (Intensity Modulated Radiation Therapy) beam radiation is started three weeks
(21 days) after the seed implant. We wait three weeks to allow some reduction of the swollen prostate, which is traumatized when the 8-inch long needles are inserted. The half-life of radioactive iodine is 60 days. By beginning the beam radiation 21 days after the implant, the beam radiation is still given during the first half-life of the radioactive iodine seeds.

Question 68:
How do you give the follow-up linear accelerator irradiation?

Answer:
First, we make X-ray pictures to document where the seeds, gold and iodine, are located. Then, we calculate the radiation dose coming out of the iodine seeds to each area in and around the prostate, including the urethra, rectum, bladder and sex nerves. With the seeds as a target, we plan the follow-up accelerator irradiation. Thus, we are logically integrating both forms of radiation to get the maximum cure rate with the least complications. Accelerator irradiation treatments are given daily, Monday through Friday, and not on weekends. Patients are administered 30 to 35 treatments, depending on the extent and location of their cancer.

Question 69:
What is IMRT beam radiation?

Answer:
IMRT is a more advanced technique of linear accelerator beam irradiation due to the greater use of computers to determine the irradiation dose. The primary effect of IMRT is to reduce the amount of radiation to the adjacent organs, such as the rectum and bladder, while increasing the amount of radiation within the prostate by shaping the beam of irradiation to a man’s prostate.

Question 70:
How do you shape the radiation to a man’s particular prostate?

Answer:
Using the gold and I-125 seeds to outline the prostate, we cross-fire the prostate from five or more different angles with beam irradiation so that the surrounding normal organs — hips, bladder, rectum and sex nerves — receive a relatively small amount of radiation. Using computers to calculate irradiation doses and to adjust blocks inside the linear accelerator to shape the beam radiation to a particular man’s prostate and seminal vesicles based upon the gold and iodine seeds, the IMRT beam radiation is delivered precisely to the prostate and the surrounding tissue for possible microscopic capsule penetration.

Question 71:
How is the daily IMRT given with the linear accelerator?

Answer:
Treatment is similar to getting a pelvic X-ray each day. After a patient is placed on the table under the linear accelerator, the gold and I-125 seeds are targeted. The accelerator is turned to the correct angle, and the computers inside the accelerator shape the X-ray beam according to the patient’s prostate shape and size from that angle. After treatment is given through one location, the accelerator is turned to a different angle, and this process is repeated until the prostate gland has been cross-fired from multiple directions. Daily adjustments to the position may be needed because the prostate can move within a man’s pelvis. This is easily detected using the gold and iodine seeds. After the patient’s treatment is finished, which usually takes less than 10 minutes, he may go back to his normal daily activites such as work, golf, the gym or anything else he would like to do. The patient returns the next day, and the process is repeated.

Question 72:
How much radiation do you give with the seeds?

Answer:
On average, 9,000 cGy are administered. Additionally, we place extra seeds, which means increased radiation, in the cancerous areas within the prostate. The middle of the cancer may receive as much as 20,000 to 25,000 cGy of radiation from the seeds. Thus, we tailor the irradiation to each man’s cancer, which goes back to the importance of the Second Opinion Pathology Report. See Questions 23–28.

Question 73:
How much radiation do you give with the accelerator treatment after the seed implant?

Answer:
We administer from 4,500 to 5,250 cGy. Thus, the total amount of radiation we give to the prostate is at least 15,000 to 15,750 cGy. More importantly, by performing an I-125 implant first, which has a 60-day half-life, and starting accelerator irradiation 21 days after the implant, both methods of irradiation can be given simultaneously. This produces a dose intensification or synergistic effect (instead of 1+1=2, think 1+1=5). The effect of radiation with dose intensification or seed activation (synergy) is more intense than simply adding the amount of radiation from each method.

Question 74:
Doesn’t giving two forms of radiation mean twice as much radiation?

Answer:
No. With ProstRcision, we reduce the seed implant dose to 9,000 cGy, as compared to the dose of 16,000 cGy typically given when men are treated only with seeds. Likewise, we reduce the accelerator radiation dose to 4,500 cGy, as compared to the 7,500 to 8,600 cGy men are given when treated only with accelerator irradiation. By reducing the dose of both seed and accelerator radiation, you can combine both treatment methods and compensate for the disadvantages of either, producing dose intensification or dose synergy (seed activation).

Question 75:
Explain dose intensification (or synergistic effect). (See Figure 15.)

Answer:

I-125 seeds have a 60-day half-life, which means they give off half their radiation during the first two months. The accelerator radiation begins 21 days after the seed implant, and it is administered for six to seven weeks, during the first half-life of the I-125 seeds. Thus, both methods of irradiation are given at the same time, which intensifies the irradiation dose. Although the seeds are already radioactive, the I-125 seeds are activated a lot more with the accelerator irradiation. Dose intensification (or seed activation) is needed because most cancer cells are located inside the prostate capsule, and dose intensification is also required to destroy all normal prostate cells.

Question 76:
To summarize, what is the purpose of the I-125 seeds as a part of ProstRcision?

Answer:

Based on the prostate biopsy, we know cancer cells are located inside the prostate. Even with cancer cell leakage, most cancer cells are inside the prostate capsule. The seeds irradiate inside the prostate but do not effectively irradiate microscopic capsule penetration cancer cells, which would be left untreated with only a seed implant. To summarize:

Advantages of the seeds — Irradiate inside the prostate and act as a target for the beam accelerator irradiation.
Disadvantage of the seeds — Prostate cancer cells that may have leaked outside the prostate capsule are under-treated by seeds alone.

Question 77:
What is the purpose of the follow-up linear accelerator radiation using IMRT or conformal beam?

Answer:
There are two basic purposes:

Dose intensification or seed activation inside the prostate (seeds and accelerator irradiation).
Irradiation of cancer cells that leak outside the prostate (microscopic capsule penetration).

Question 78:
When a prostate biopsy is performed, can cancer cells stick to the needle and be pulled through the capsule and outside the prostate either into the rectum or to the area below the prostate?

Answer:
First, it is unknown whether or not cancer cells can be pulled outside the prostate by either the biopsy needles or the seed implant needles. However, if cancer cells could be pulled outside the prostate by either of these needles, it would make no difference with ProstRcision. A very small part of the rectum adjacent to the prostate gland receives irradiation from the external beam and, thus, would destroy any prostate cancer cells pulled out of the prostate because of a prostate biopsy. Since with ProstRcision beam irradiation is given after the implant, any cancer cells that could be pulled outside the prostate by the implant needles would later be irradiated by the external beam portion. Thus, pulling cancer cells outside the prostate by either the biopsy needle or implant needles would not make any difference with ProstRcision. But this issue could be a problem for men treated with radical prostatectomy, men who were treated with seed implant only, and men given beam radiation before the seed implant.

Question 79:
How would ProstRcision cure a man with these medical findings? Twelve needle cores were taken at prostate biopsy, and four showed cancer — two with Gleason score 3+4=7 and two with Gleason score 6. PSA was 7.5 and stage T1c disease.

Answer:
For discussion purposes, let’s assume there were 100 prostate cancer cells. Based on the prostate biopsy report, we know that most, if not all, of the cancer cells are located in the prostate, but we also know there is at least a 41% risk for having microscopic capsule penetration (Partin tables²⁹), which means leakage of prostate cancer outside the prostate, near the rectum or bladder, because of cancer in four of 12 needles, two with Gleason score 3+4. To cure this man of prostate cancer, we must destroy all 100 prostate cancer cells. We know cancer cells are inside the prostate capsule, and there is a 41% chance of cancer cell leakage outside the prostate.

Question 80:
How does ProstRcision work? (See Figure 16.)

Answer:
Because it is impossible before any treatment to know if a man has microscopic capsule penetration, we always assume that a man may have cancer cell leakage through the capsule; and because you essentially have only one chance to be treated for cure, you do not want to miss or under-treat prostate cancer. Let’s assume that of the 100 cancer cells, 90 are in the prostate and 10 have leaked outside the prostate. Since most cancer cells (90) are inside the prostate, more irradiation is required within the gland. This is accomplished by the irradiation from the iodine seeds combined with the IMRT beam radiation, which creates a synergistic effect on radiation dose intensification. Since there are fewer microscopic capsule penetration cancer cells (10 cells), the IMRT beam radiation (which radiates both inside and outside the prostate) would also destroy cancer cell leakage. Thus, we would destroy all 100 cancer cells, and this man would be cured of his cancer. See Figure 16. This differs from radical prostatectomy. (See Question 94 for further information.) Additionally, the synergistic effect of the seeds and beam radiation inside the prostate would destroy all normal prostate cells to prevent a new prostate cancer. After all, whatever caused prostate cancer the first time could do it a second time. Destroying all normal prostate cells and the seminal vesicles will have no effect on a man, nor will it affect sexual function except that he will produce little or no semen on ejaculation because semen is produced by normal prostate cells.

Question 81:
Do you tailor treatment according to the Second Opinion Prostate Biopsy Report and other cancer findings? (See Figure 17.)

Answer:
Yes. How we treat a man with ProstRcision and the chance of curing his prostate cancer depends on his cancer findings, especially his prostate pathology report, which is why the Second Opinion Pathology Report is so important. For example, a man with an average size prostate, Gleason score 6 cancer and 10% in one of 12 needles with no perineural invasion would receive 68 seeds followed by six weeks of beam radiation. On the other hand, consider a patient who had Gleason score 4+3=7 with five needle cores positive, 40–70% cancer in each needle with 60–70% grade 4 and perineural invasion. This patient would receive an average of 85 seeds with extra seeds implanted in the area of the prostate that had the 4+3=7 Gleason score cancer. This would give extra irradiation to the 4+3 cancer. Additionally, he would receive seven weeks of beam radiation after the implant. As you can see, treatment is different for each patient and is tailored to a man’s individual cancer findings, especially the pathology report.

Question 82:
What would happen to the PSA of 7.5 ng/ml after treatment with ProstRcision?

Answer:
Since PSA is produced only by prostate cells, both normal and cancerous, destruction of all normal prostate cells and the 100 cancer cells would mean there would be no cells in this man’s body to make PSA. Therefore, the PSA of 6.8 ng/ml after ProstRcision would fall to PSA 0.2 ng/ml or lower and remain at this level forever.

Question 83:
What happens to the prostate gland after a man is treated with ProstRcision?

Answer:
We do not precisely know. We speculate that both cancerous and normal prostate cells are destroyed with the prostate shrinking and turning into scar tissue. The debris from the destroyed prostate cells can be either excreted from the body or the prostate cell components be used to make new, normal cells someplace else.

Radical Prostatectomy

Question 84:
What is a radical prostatectomy?

Answer:
Radical prostatectomy is a major surgical procedure performed under general anesthesia in a hospital operating room where the urologist removes the prostate gland and the seminal vesicles (an organ attached to the top of the prostate). There are three methods to perform radical prostatectomy, but all do basically the same thing. The prostate is dissected along with the seminal vesicles away from the bladder and off the rectum. The urethra tube is cut across, both at the top of the prostate where the tube joins the bladder and also at the bottom of the prostate. The bladder is then pulled down into the man’s pelvis and sewn to the lower part of the urethra located below where the prostate used to be. Depending on the extent of the cancer, the surgeon will try to preserve the sex nerves. The pelvic lymph nodes may also be removed. The surgery takes approximately two hours to perform, but may take longer, depending on the skill level of the urologist. Additionally, depending on the skill of the surgeon, a man wears a urinary catheter for an average of one week after the procedure, but some men may require a catheter for a month or longer. Radical prostatectomy is not typically performed on men older than age 70 because of the increased possibility of severe complications.

Question 85:
What are the three techniques for performing a radical prostatectomy?

Answer:
The modern standard technique developed at Johns Hopkins has been an open radical prostatectomy (ORP), where a surgeon makes an incision in a man’s lower abdomen and begins his dissection of the prostate. A variant of the ORP is the perineal approach, in which the incision is made through a man’s bottom; however, this is an uncommon procedure. The second technique is a laparoscopic radical prostatectomy (LRP), where the urologist makes four 1/2-inch incisions in a man’s lower abdomen. Then, the urologist inserts tubes through which he or she manually removes the prostate. The third and newest technique, the robotic radical prostatectomy (RRP), is also a laparoscopic radical, but the instruments are remotely controlled by a device called the da Vinci^® robot.

Question 86:
Of the three techniques for radical prostatectomy, which method has the best cure rate?

Answer:
Cure rates are the same with any radical prostatectomy technique. With highly experienced urologists performing surgery at hospitals such as Johns Hopkins, Memorial Sloan Kettering, Cleveland Clinic or Northwestern University, the overall 10-year cure rate ranges from 70–80% for both the open and laparoscopic method.^3,4,5,6 With lesser skilled urologists, the cure rate may be lower. Dr. Mani Menon and his team in Detroit have the oldest and largest robotic radical prostatectomy (RRP) study (2,766 men), and their five-year cure rate is 84%.⁷ This cure rate will continue to fall, and within 10 years, it should be between 70–80% as with the other techniques. Thus, the cure rate with radical prostatectomy is the same regardless of whether it is open, laparoscopic or robotic. A variation in cure rates among skilled urologists is almost always attributed to patient selection and not technique of radical. A doctor who operates on only early prostate cancer will get better cure rates than one who operates on more advanced disease.

Question 87:
If you cut out the entire prostate, why would you not be cured with radical prostatectomy?

Answer:
You may not be cured due to microscopic capsule penetration through the capsule, and/or spread of cancer (metastases) elsewhere in a man’s body, which is not detectable at the time of surgery. A study from the Southwest Oncology Group documented that the most common reason for men with advanced cancer not to be cured with radical prostatectomy is because cancer cells were left behind in the prostate bed where the prostate gland was originally.³² The reason for this is cancer cell leakage, which prevents all cancer cells from being removed at the time of prostatectomy.⁶ The 10-year cure rates significantly decrease when microscopic capsule penetration is discovered.³¹ This happens with any of the techniques, open, laparoscopic or robotic.³³ See Questions 31–41 on how prostate cancer works.

Question 88:
What is the most common location for microscopic capsule penetration that causes cancer cells to be left behind after radical prostatectomy?

Answer:
Microscopic capsule penetration can occur at any location around the prostate and result in radical prostatectomy failure. However, the most common location for cell leakage is at the bottom of the prostate (the apex).^34,35,36 For any of the three techniques, the most critical and difficult part of a radical prostatectomy is removing the apex of the prostate, where the urethra is also cut across. There are several reasons for this difficulty. First, it is common for prostate cancer to be located at the bottom of the prostate. According to RCOG’s database, 67% of men on biopsy have cancer at the bottom of the prostate. The second reason is that there is no capsule to contain prostate cancer at the apex, which means that prostate cancer can easily leak out of the prostate in this area (see Question 33 and Figure 6). Third, one of the large muscles that controls urination, the external sphincter muscle, is located at the apex of the prostate. A surgeon has a difficult decision when dissecting the apex. If the surgeon tries to cure a man of his prostate cancer, the procedure may remove too much of the muscle that controls urination, causing a man to leak urine. On the other hand, if the surgeon tries to ensure that the man will not leak, he can leave cancer cells behind. To further complicate the procedure, the right and left sex nerves converge at the apex of the prostate. As with the muscles that control urination, if the surgeon tries to preserve these sex nerves, he may leave cancer behind; conversely, the surgeon may also leave the man without sexual function if he removes too much tissue in his attempt to cure the cancer. Although cancer cells can be left at any location, leaving cancer cells behind at the apex is the most common reason for surgery to fail to cure men with prostate cancer. Despite this problem, it is remarkable that highly experienced surgeons can successfully dissect the apical area and cure many men with microscopic capsule penetration, if it is a small amount.

Question 89:
Since the operation field is magnified with the robotic radical prostatectomy, can surgeons see microscopic capsule penetration?

Answer:
No, the robotic technique does not help surgeons see microscopic capsule penetration.³⁴

Question 90:
If I had a radical prostatectomy and the pathologists guaranteed that all cancer was inside the prostate with no microscopic capsule penetration, would this guarantee cure?

Answer:
No. Even if the pathologist, based upon examination of the whole prostate under the microscope, reports that all the cancer is contained inside the prostate and no microscopic capsule penetration is present, 14% of men still are not cured and have regrowth of prostate cancer within 10 years of surgery.³⁷ Evidently, microscopic capsule penetration can be missed or cancer can spread by other means such as small veins.

Question 91:
Since removing the apex of the prostate is the most critical part of radical prostatectomy and may cause urinary leakage, how often do men leak after radical prostatectomy?

Answer:
Urinary leakage is defined as men wearing one or more pads per day, and it varies with the skill of the surgeon. With highly-experienced surgeons, the chance of urinary leakage has been reported from 8–17%.^38,39,40,41 The leakage rate is the same regardless of radical prostatectomy technique — open, laparoscopic or robotic.

Question 92:
What is the risk of loss of sexual function following radical prostatectomy?

Answer:
With highly-experienced surgeons, the overall loss of sexual function occurs in approximately one-third of men who have radical prostatectomy, regardless of the technique used.^33,40,42 Some reports say more and others less, which is attributed to patient selection. With less experienced surgeons, the chance of losing sexual function may be 50% or greater.

Question 93:
I understand that more men are choosing the robotic radical prostatectomy technique over the other two methods. Is there any advantage to the robotic method?

Answer:
The cure and complication rates are the same for all three techniques.^33,42 The only documented advantage to the robotic technique is that men are discharged from the hospital within one to two days after the robotic, as compared to four to seven days with the open method. There is also less blood loss and a lower transfusion rate with the robotic technique, but a significant loss of blood is very low with any method of radical prostatectomy if an experienced surgeon performs the procedure. There is one major drawback to robotic surgery. With the open method, the surgeon can not only look, but also feel for cancer with his hand. But with the robotic method, since the surgeon is operating robotic laparoscopic instruments 10 feet away from the patient, there is no palpation of the prostate for cancer, only the ability to look at the prostate. This is a problem for robotic surgery, especially for more advanced cancers.

Question 94:
If there is no improvement in cure rate or fewer complications with the robotic technique, why is it the most common way to perform radical prostatectomy?

Answer:
Knowing that robotic radical prostatectomy does not improve the results over the open or laparoscopic, the only reason for robotic being the most common method currently used is because of men’s perception that the robotic technique is better. Some urologists believe that the robotic radical prostatectomy technique gives better results, but their analysis is typically flawed because the robotic method has been used on men with early prostate cancer and compared with men who have had an open prostatectomy for more advanced disease.⁵ How a doctor selects patients can influence results dramatically. The fundamental key to curing men with radical prostatectomy is the skill and experience of the urologist NOT the radical prostatectomy technique.¹⁷ A highly-skilled urologist performing an open radical prostatectomy can achieve the same results as a highly skilled urologist practicing the robotic technique.

ProstRcision vs. Radical Prostatectomy

Question 95:
Compare ProstRcision with radical prostatectomy, whether open, laparoscopic or robotic. (See Figure 18.)

Answer:
The goal of ProstRcision and radical prostatectomy is the same: destroy all prostate cancer cells and normal prostate cells. The PSA goal of ProstRcision and radical prostatectomy is also the same: achieve PSA 0.2 ng/ml or less after treatment and remain at PSA 0.2 ng/ml forever with cure rates measured 10 years following treatment. However, there is considerable difference in how ProstRcision and radical prostatectomy work to achieve these goals. With radical prostatectomy, the entire prostate gland is surgically removed with critical dissection at the apex, while striving to leave the muscles that control urination and preserve sex nerves. In contrast, ProstRcision destroys all prostate cancer and normal prostate cells without removing the urethra or damaging muscles that control urination. Additionally, the sex nerves often remain intact. A wider area around the prostate is treated with ProstRcision than with radical prostatectomy. Consequently, there is a difference in results, especially with regard to three issues: microscopic capsule penetration (particularly at the apex), urinary leakage and the rate of PSA fall after treatment. See Figure 18.

Comparison of ProstRcision and radical prostatectomy

Question 96:
How does ProstRcision differ from radical prostatectomy when treating microscopic capsule penetration?

Answer:
As stated earlier, a cause for failure of cure after radical prostatectomy is because cancer cells are left behind in the area of the prostate, which is due to microscopic capsule penetration especially if the surgical margins are positive, which indicates the cancer was cut across.⁴³ See Figure 18 where the dotted line shows the cut line of surgery with cancer cells left behind at the apex and one side of the prostate. This is called positive surgical margin. In contrast, with ProstRcision, microscopic capsule penetration and positive surgical margins are a non-issue. The follow-up IMRT beam radiation of ProstRcision destroys microscopic capsule penetration cancer cells.

Question 97:
Since the apex (bottom) of the prostate is the most common location for microscopic capsule penetration, is this location a problem for ProstRcision as with radical prostatectomy? (See Question 88.)

Answer:
No. Although dissection of the apex is the most critical part of surgical removal of the prostate and where prostate cancer is located 67% of the time, the apex is the easiest area to treat with ProstRcision. Seeds can be placed at and below the apex. The beam irradiation can reach even further below the apex, including the sphincter muscle. In fact, the apex is the area that can be irradiated with the widest margin. Thus, cancer at the apex is the worst location for radical prostatectomy but is the best location for ProstRcision.

Question 98:
How would you compare cure rates between ProstRcision and radical prostatectomy? (See Table 7.)

Answer:
Radical prostatectomy is an excellent way to treat men with early stage prostate cancer. Most men with early stage prostate cancer do not have microscopic capsule penetration, and men with very small amounts of cancer cell leakage can still be cured with surgery. Therefore, the cure rates with radical prostatectomy are high (76–80%, refer to Table 1). However, a substantial number of men who have radical prostatectomy have significant microscopic capsule penetration to the point that 11–27% (depending on how well patients are selected for surgery) will have microscopic capsule penetration cancer cut across, leaving positive surgical margins.^33,39,17,44 Unfortunately, a patient cannot know whether he has microscopic capsule penetration or positive surgical margin until three to four days after surgery when the pathologist examines the specimen. Since with ProstRcision, microscopic capsule penetration is not an issue, the overall cure rates should be better than with surgery. The overall 10-year cure rate for ProstRcision is 83% for men with early, intermediate and advanced cancer. Radical prostatectomy is typically performed only on men with early to intermediate prostate cancer. In contrast, with ProstRcision, we treat not only men with early and intermediate cancer, but also men who have advanced cancer who could not be cured with radical prostatectomy. For a more accurate comparison, cure rates after ProstRcision were calculated for men with early and intermediate cancer only. Table 7 compares the cure rate of ProstRcision with radical prostatectomy for men with early and intermediate cancer.

Question 99:
Robotic radical prostatectomies have been performed for less than 10 years. How can a doctor calculate a 10-year ICR for robotic surgery?

Answer:
There is no difference in cure rate between an open radical prostatectomy and robotic radical prostatectomy. Since the cure rate is the same urologists can calculate a 10-year ICR based on all the radical prostatectomies they have performed.

Question 100:
Is there a difference in urinary leakage between ProstRcision and radical prostatectomy?

Answer:
Yes. Since the most critical part of a radical prostatectomy is removing the apex of the prostate where microscopic capsule penetration is most common, and one of the large muscles that control urination is located there, this muscle could be cut out at surgery. This is the primary cause for 8–17% of men experiencing leakage after radical prostatectomy, including the robotic or da Vinci technique.^34,35,36,37 With ProstRcision, there is no urinary leakage because the muscle at the apex of the prostate is not removed. The only exception to this observation is if men, prior to ProstRcision have had a TURP (roto-rooter operation) where the other large muscle (the bladder neck muscle) has been removed, or in men who have severe urinary urgency such that they leak urine before they get to the toilet.

Question 101:
Is there a difference in preserving sexual function between radical prostatectomy, including the robotic technique and ProstRcision?

Answer:
Although difficult to compare, there appears to be approximately the same degree of preservation of sexual function between ProstRcision and radical prostatectomy, when surgery is performed by highly-skilled urologists. However, a study from Duke University showed that 24% of men who had a robotic radical prostatectomy regretted their decision to have this surgery.⁴⁵ The reason for their regret was that men were told sexual function would be preserved, but this did not happen. Instead, many men lost sexual function after robotic prostatectomy.

Question 102:
I have been told that if you are not cured with radical prostatectomy, you can be treated with irradiation; but if you are not cured by irradiation, you cannot have a radical prostatectomy. Is this true?

Answer:
No. Men can receive beam irradiation after radical prostatectomy, which helps some men who are not cured with surgery.⁴⁶ However, you can also have a radical prostatectomy after irradiation, which can also help some men not cured by irradiation.⁴⁷ Either way, a man gets two treatments instead of one; however, the chance of complications is increased, whether you are treated with salvage irradiation or salvage prostatectomy. It is best to make a well-informed, practical decision regarding your treatment method and doctor BEFORE any treatment, rather than counting on salvage treatment where you risk still not being cured and increased chances for urinary, sexual and rectal complications.

Question 103:
An undetectable PSA (0.2 ng /ml) is the goal after both ProstRcision and radical prostatectomy. Is there a difference in how fast the PSA falls after each of these treatments? (See Figure 19.)

Answer:
Yes. Since all normal prostate cells and, hopefully, all cancer cells are suddenly removed with radical prostatectomy, a man’s PSA should fall to 0.2 ng/ml within six weeks of surgery.¹ In contrast, after ProstRcision, the average time to achieve an undetectable PSA is 27 months. The hallmark of cancer is growth — cancer cells reproducing and making more cancer cells. Irradiation primarily kills cancer by preventing cancer cells from reproducing. Thus, cancer cells may live for a period of time and make PSA. However, these cells will not be able to reproduce and will eventually die. This is measured by the slower time for PSA to achieve PSA 0.2 ng/ml after ProstRcision.

Time to reach PSA 0.2 ng/ml with ProstRcision

Question 104:
If you see a man with early prostate cancer in consultation at RCOG, do you recommend ProstRcision over radical prostatectomy?

Answer:
No. We recommend he conduct research and make a personal decision about treatment. After all, this is a decision he will live with for the rest of his life. This brochure is designed specifically to inform men of a decision-making process. If a man is less than 70 years old and has early prostate cancer, we recommend he focus on cure (along with urinary leakage and loss of sexual function), instead of focusing on treatment. He should ask his urologist for a graph of his 10-year ICR with robotic radical prostatectomy, or any radical prostatectomy, and compare that with the 10-year Individual Cure Rate with ProstRcision that we give him. If a man is older than 70 or has advanced prostate cancer, we do the same, but recommend that he consider ProstRcision because it is easier to undergo for older men. Additionally, men with advanced prostate cancer will have a much better chance for cure with ProstRcision than surgery. For the few men who cannot have anesthesia for medical reasons for ProstRcision or radical prostatectomy, we recommend IMRT beam radiation.

Definition of Cure

Question 105:
How do you determine if a man is cured of prostate cancer? (See Figure 20.)

Answer:
Cure is determined by the PSA test after any treatment. However, instead of one definition of cure for all treatment methods so that you can compare methods, there are three different PSA definitions of disease freedom that doctors use:

PSA cutpoint 0.2 ng/ml. This definition is the only one that defines cure. Cure refers to the fact that a man’s PSA after treatment must fall to 0.2 ng/ml or lower and remain at this level forever. Recurrence, or regrowth, of prostate cancer after treatment is defined by a rise above PSA 0.2 ng/ml, which is For example, a PSA rise to 0.21ng/ml or confirmed by a second rise above 0.2 ng/ml.¹ more that is confirmed by a second PSA of 0.21 ng/ml or more. ProstRcision and radical prostatectomy are calculated with PSA cutpoint 0.2 ng/ml.
The ASTRO definition. This definition does not define cure. In this definition, the PSA does not have to fall to 0.2 ng/ml. Recurrence is defined by three consecutive (the key word is consecutive) PSA rises above the lowest PSA level. For example, consider a man’s PSA that falls to 0.2 ng/ml after treatment, then rises to 0.7 ng/ml, then 1.8 ng/ml, is held at 1.8 ng/ml, then goes to 2.9 ng/ml and finally reaches 4.4 ng/ml. Since there were not three consecutive PSA rises, this patient would still be considered free of prostate cancer according to the ASTRO definition, even though his PSA went from 0.2 to 4.4 ng/ml. If his PSA were to go to 7.3 ng/ml, he would experience three consecutive rises and would be considered as having recurrent prostate cancer.
Nadir+2 (or Phoenix) definition. Like the ASTRO definition, the nadir+2 definition does not define cure. Also, like the ASTRO definition, PSA does not have to fall to PSA 0.2 ng/ml. Recurrence of prostate cancer is defined by a rise of 2.0 ng/ml above the lowest level achieved. If a man’s PSA fell to 0.2 ng/ml, then to 0.7 ng/ml, followed by 1.1 ng/ml, then 1.4 ng/ml, then 1.6 ng/ml, and finally 1.9 ng/ml, this man would still be classified as prostate cancer free even though his PSA is rising. To be classified as having recurrent cancer, the PSA would have to rise to 2.2 ng/ml.

As you can see, there is a marked difference in the PSA cutpoint 0.2 ng/ml definition of cure compared to the ASTRO and nadir+2 definition, neither of which defines cure from prostate cancer. Instead, the latter two definitions only define “control” or “remission” of prostate cancer.^48,49 To document this, a small study of men who received beam radiation for prostate cancer followed years later by prostatectomy revealed that 50% of the men classified as in remission by the nadir+2 definition still had cancer in their prostate when the specimen was examined under the microscope.⁵⁰ All of this is important for you to know because, with two exceptions, all peer-reviewed medical reports on treatment methods for prostate cancer other than ProstRcision and radical prostatectomy have outcomes calculated using either the ASTRO or nadir+2 definition. Doctors using the eight other treatment methods listed in Table 1 refuse to calculate cure rates with PSA cutpoint 0.2 ng/ml because they consider this definition too strict.⁴⁹ See Figure 20.

PSA less than 0.2 ng/ml compared to the two radiation definitions of recurrence

Question 106:
This does not make sense. Why don’t all doctors use PSA cutpoint 0.2 ng /ml, which is the only definition that shows cure from prostate cancer? (See Table 6.)

Answer:
The reason doctors calculate with the ASTRO or the nadir+2 definition is because these two definitions produce a lot better outcomes than calculations with PSA 0.2 ng/ml. This is extremely important for a man with prostate cancer to know, because the purpose of treatment is to be cured and not just to have the cancer controlled or put in remission. If all doctors calculated cure rates with PSA 0.2 ng/ml after all treatment methods for prostate cancer, you would find that many treatment methods have very poor cure rates (see Table 1).

Question 107:
Is there a difference in outcomes if you calculate cure rates with PSA 0.2 ng /ml in a group of men with prostate cancer and then calculate outcomes in the same group of men but use the ASTRO or nadir+2 definition?

Effect of definition of cure on cure rates

Answer:
There is a huge difference. One medical report made this comparison in men treated with external beam radiation with the conformal technique, where 6,500–7,000 cGy was given to the prostate. The study consisted of 4,839 men treated at several major medical centers including M.D. Anderson Hospital, Fox Chase, Cleveland Clinic, Mayo Clinic, University of Michigan and Memorial Sloan Kettering Hospital.⁸ Cure rates were calculated with PSA 0.2 ng/ml in these men, and outcomes were calculated using the ASTRO definition. Table 6 shows the difference in outcomes if the definition is changed. As you can see, there is a big difference in results, and this depends solely on which definition a doctor decides to use. In this report, the doctors claim that 49% of men were free of cancer using the ASTRO definition, when in fact only 3% of these men were actually cured. Had the nadir+2 definition been used, it would have given the same misleading results as the ASTRO definition. Calculations of outcomes after treatment of prostate cancer using either the ASTRO or nadir+2 definition are inflated.50 Further, they do not measure cure of prostate cancer. Consequently, 10-year outcomes between treatment methods cannot be compared unless the SAME PSA definition is used.

Question 108:
Since the ASTRO and nadir+2 definition do not measure cure and produce inflated results, what can a man do to get accurate cure rates from any doctor using any treatment method?

Answer:
Be precise and ask the doctor for the number of men he has treated; ask how many of those same men had PSA 0.2 ng/ml 10 years after treatment (see the four questions for doctors in Question 2). To give men with prostate cancer an apples-to-apples comparison, we estimated the cure rates for the 10 treatment methods listed in Table 1 as if calculations were made with PSA cutpoint 0.2 ng/ml.

Question 109:
Is it fair to estimate cure rates using PSA 0.2 ng / ml for the doctors who use other treatment methods?

Answer:
Doctors who write medical research papers or talk to men about the outcomes of treatment methods for prostate cancer choose whichever definition they want to use for their calculations. Doctors who calculate with the ASTRO or nadir+2 definition chose to calculate with these methods instead of using the standard definition of cure, which is defined as PSA cutpoint 0.2 ng/ml. We suspect that when doctors calculate using PSA 0.2 ng/ml, they find the results to be very low and decide to “improve” them by calculating with the ASTRO or nadir+2 definition, as in Question 104. At RCOG, we could “improve” our outcomes by calculating with the ASTRO or nadir+2 definition rather than using PSA cutpoint 0.2 ng/ml. In fact, we could change approximately one-third of the men in our database who have recurrent prostate cancer to being “free of cancer” which would significantly (but artificially) inflate our results. However, we calculate with PSA 0.2 ng/ml because we want to give men accurate cure rates, which is the same reason urologists calculate with PSA 0.2 ng/ml after radical prostatectomy. The only purpose for estimating cure rates with PSA 0.2 ng/ml for all treatment methods for prostate cancer (Table 1) is to be able to compare cure rates using a standard definition of cure for prostate cancer (apples-to-apples) so that men can make reasonable comparisons between treatment methods and be able to decide for themselves which method to choose.

Comparing Treatments

For questions 110-117, please reference Table 1 below:

Question 110:
What is the cure rate if a man is treated only with IMRT external beam radiation?

Answer:
All IMRT beam radiation cure rates have been calculated with either the ASTRO or nadir+2 definition. The 10-year cure rate with beam radiation of 6,500–7,000 cGy is only 3%.⁸ With IMRT beam radiation, the doses have been increased approximately 20% (7,800–8,600 cGy), and we now find prostate cancer earlier with the PSA test.^53,54 Due to these factors, it is estimated that overall cure rates for IMRT beam radiation would increase from 3% to approximately 25% (Table 1).

Question 111:
What is the cure rate for men treated only with seed implant, either radioactive I-125 or palladium seeds, and no beam radiation?

Answer:
Doctors from several major facilities, including M.D. Anderson, New York Prostate Institute, Mayo Clinic in Scottsdale, the Seattle Center, Cleveland Clinic, Harvard, Memorial Sloan Kettering and University of Michigan, treated 2,693 men with seed implant alone (either iodine or palladium seeds) and calculated their 10-year cure rates with PSA cutpoint 0.5 ng/ml.⁹The overall 10-year cure rate was only 35%. Had the cure rate been calculated with PSA cutpoint 0.2 ng/ml, a stricter definition, the 10-year cure rate would have been less, probably 30% (Table 1). Furthermore, seed implants alone are almost always used for men with very early prostate cancer — pretreatment PSA below 10.0 ng/ml and Gleason score 6. Because of this low cure rate, especially in men with early cancer, treatment with seed implant only for prostate cancer is not recommended.

Question 112:
What is the cure rate if doctors first give beam radiation followed by a seed implant, the reverse of ProstRcision?

Answer:
One group of highly-experienced seed implant doctors did calculate 10-year cure rates with PSA cutpoint 0.2 ng/ml. The 10-year cure rate was 65%.¹⁰ This 10-year cure rate will be much better than those achieved by the average seed implant doctor in the United States. This is an acceptable way to treat men with prostate cancer, but the cure rates are significantly less than those after radical prostatectomy or ProstRcision.

Question 113:
What is the cure rate for cryosurgery for prostate cancer?

Answer:
Cryosurgery is a treatment for prostate cancer that involves freezing the prostate gland. All outcomes published in medical journals have been calculated either with the ASTRO or nadir+2 definition. One medical report did show that only 28% of men treated with cryosurgery had PSA 0.2 ng/ml or less five years after treatment (Table 1).¹¹ Ten-year cure rates will be even lower. Because of poor cure rates, cryosurgery is not recommended as a treatment for men when first diagnosed with prostate cancer. However, it is of use as a salvage treatment for men who have recurrent cancer in the prostate after irradiation.⁵⁵

Question 114:
What is the cure rate for High Dose Rate (HDR) irradiation, using the radioactive isotope called iridium (IR-192)?

Answer:
In contrast to radioactive iodine or palladium seeds, which are both permanent implants, iridium is a temporary implant whereby a patient is taken to the operating room on two or more occasions to have the iridium inserted into the prostate for only a few minutes at a time, later followed by beam radiation. Most medical reports on this method have had outcomes calculated with either the ASTRO or nadir+2 definition. One overall report did show that 72% of men achieved PSA 0.2 ng/ml within five years after treatment.¹² However, whether men maintained PSA 0.2 ng/ml through 10 years of checkups is unknown. Given these factors, it is estimated that the 10-year cure rate for HDR will be approximately 60%. An increased number of complications have resulted from HDR, especially strictures (scarring) of the urethra tube, which leads to urinary blockage and requirement of a catheter or additional surgery. Men with prostate cancer would have a better chance for cure with fewer complications if treated with either radical prostatectomy or ProstRcision.

Question 115:
What is the cure rate with proton beam irradiation for prostate cancer?

Answer:
The doctors at Loma Linda University have treated the largest number of men (1,255) with proton beam irradiation for prostate cancer but calculated their outcome with the ASTRO definition.¹³ Given the degree that ASTRO or nadir+2 definition inflate the results with external beam radiation, it is estimated that the cure rate for proton beam radiation would be approximately 30% if calculated with PSA cutpoint 0.2 ng/ml. Proton beam irradiation is not recommended for men with prostate cancer because the cure rate is one-half of either radical prostatectomy or ProstRcision. The only proven use for proton beam irradiation in the entire field of cancer is for a few rare childhood cancers.

Question 116:
What is the cure rate for High Intensity Focused Ultrasound (HIFU) treatment methods for prostate cancer?

Answer:
All medical studies of cure rates have been calculated for HIFU with either the ASTRO or nadir+2 definition. One report revealed that 42% of men who received HIFU treatment achieved PSA 0.5 ng/ml.¹⁴ If a 10-year cure rate were calculated with PSA cutpoint 0.2 ng/ml, it is estimated the cure rate for HIFU would be approximately 30% (see Table 1). The only known role for HIFU in the treatment of prostate cancer is as salvage treatment.⁵⁶

Question 117:
What is the cure rate for Cyberknife irradiation?

Answer:
Cyberknife is a technique for giving beam irradiation. Although the owners of the Cyberknife Company have claimed that Cyberknife cures prostate cancer with little to no side effects, no medical study has ever been published in a peer-reviewed medical journal showing the results with this technique in comparison with other treatments for prostate cancer. Two highly-respected doctors, Bentzen and Wasserman from the University of Wisconsin School of Medicine and Washington University School of Medicine, respectively, wrote a report in a peer-reviewed medical journal concerning the false claims of success by the owners of Cyberknife. These authors pointed out that Cyberknife is an unproven, experimental treatment for prostate cancer that has only been in use for approximately three years. Men with prostate cancer should not be treated with Cyberknife unless they volunteer in writing to be part of a medical experiment.¹⁵ Since men usually have only one chance to be cured, there are significantly better proven treatment methods for prostate cancer than Cyberknife.

Watchful Waiting

Question 118:
What about watchful waiting as management for prostate cancer?

Answer:
Watchful waiting (i.e., active surveillance or expectant management) is a unique way to manage cancer and is based on the observation that many men diagnosed with prostate cancer die from other causes before dying from their prostate cancer.⁵⁷ Men receive no treatment for their disease but are followed with PSA levels every six months and have a repeat prostate biopsy every two years. Medical studies have shown that 8–40% of men who initially elect watchful waiting will need to be treated within five years.^58,59 There are two basic problems with watchful waiting. Although most men with early prostate cancer will not have significant progression, you never know which man will have spread of his cancer. Additionally, it is often difficult psychologically for men and their wives to be told they have cancer and then be advised to do nothing except watch it. For this reason, although offered, few men elect watchful waiting unless they are elderly or have other severe medical problems.

Hormones

Question 119:
Do you ever give hormones along with ProstRcision?

Answer:
Hormones are rarely given (less than 1% of men) with ProstRcision and only if men have very advanced disease. However, we have seen a large number of men who received hormones before they came to RCOG for ProstRcision. Almost all these men had side effects and complications from hormones but no benefit.

Question 120:
How do you know these men did not benefit from hormones?

Answer:
Approximately 8% of patients we have treated at RCOG were given hormone shots by their doctor before they contacted us. We compared cure rates of these men with those men treated with ProstRcision and no hormones. Cure rates are the same. In other words, men who got hormones did not have a better cure rate. Consequently, almost all men who received hormones before ProstRcision did so needlessly.

Question 121:
What complications can result from hormones?

Answer:
There are a number of complications. Almost all men get hot flashes, similar to a woman going through menopause, which can last for a year or more with just one hormone shot. Virtually all sexually-active men will lose sexual function for many months — both the ability to achieve an erection and the desire to have sex — after hormone treatment. Furthermore, many of these men never regain sexual function. If given over a long period of time, hormones can also cause thinning of the bones (osteoporosis), which increases your chance of breaking a bone. Additional complications are weight gain, muscle weakness and an overall loss of energy. Recent medical studies have documented that men who receive hormones have increased problems with thought process (making decisions or thinking clearly), as well as an increased chance of diabetes and heart attacks.^{60,61,62,63,64} The degree to which men have these various side effects and complications varies from person to person, as well as how long hormones are given. Consequently, with rare exceptions, hormones, are not used at RCOG.

Question 122:
Why do so many doctors recommend hormones along with irradiation?

Answer:
Medical studies have shown that men with advanced cancer benefit from a combination of hormones and irradiation but only if the irradiation is external beam radiation.^65,66,67 In contrast, medical studies of seed implantation plus hormones show no benefit to men.^68,69 Unfortunately, a lot of doctors wrongly assume that if hormones benefit men who have only beam radiation, then all men who receive radiation would benefit. These doctors make a drastic mistake, causing men who get hormones to have needless complications.

Question 123:
Why would men who have only beam radiation benefit from hormones, but not those men who receive ProstRcision?

Answer:
If men are treated with a method that has a low cure rate (estimate is 25% for IMRT beam radiation), they might benefit from hormones. However, if you give a treatment that has a high chance of cure, such as ProstRcision (cure rate of 83%), the cure rate is not improved (see Table 1). The same is seen with surgery. Men who receive hormones plus radical prostatectomy (cure rate 70–80%) have no improvement in cure rates versus radical prostatectomy alone.⁷⁰

Treatment Effects

Question 124:
What is the most common problem men experience after ProstRcision?

Answer:
The most common side effect seen after ProstRcision is a weak urinary stream with more frequent urination and more urgency. These symptons vary greatly from person to person and are primarily related to the size of a man’s prostate and the amount of urinary symptoms he has prior to the seed implant. For example, men with normal-sized prostates and no urinary problems before the implant have few, if any, symptoms afterwards. Men who have a weak stream after ProstRcision typically find their symptoms gradually resolve over 6-12 months as the prostate shrinks from the trauma and the normal and cancerous prostate cells disintegrate from ProstRcision. The cause of the weak stream is from trauma to the prostate due to the insertion of the eight-inch long needles into the prostate gland through which the seeds are injected. Insertion of these needles causes sudden prostate swelling, which leads to compression (squeezing) of the urethra tube that empties the bladder and runs through the middle of the prostate. The weak stream from ProstRcision has nothing to do with irradiation. In fact, we see very little effect from irradiation, neither seeds nor beam.

Question 125:
Can you do anything for the urethral compression?

Answer:
Yes. Men who have a significantly slow stream are offered medication called alpha blockers, such as Flomax^®, Uroxatral^®, Cardura^® or Hytrin^®. This medication relaxes muscles inside the prostate irritated by the sudden swelling and, in turn, relieves pressure on the urethra, which results in significantly better urination in most men.

Question 126:
Can men develop urinary blockage after the seed implant of ProstRcision

Answer:
Yes. Overall, 2.6% of men will have enough swelling after the implant that they have blockage of the urethra and require insertion of a urinary catheter. The median time to wear a urinary catheter in the few men who have urethral blockage is six days. This is approximately the same length of time (average seven days) that all men wear a catheter after radical prostatectomy.

Question 127:
Do men develop urinary leakage (incontinence) after ProstRcision?

Answer:
No, except for men who have had a prior TURP (roto-rooter operation) or have severe urinary urgency before the seed implant of ProstRcision. This issue was discussed in Question 100.

Question 128:
What about rectal problems after ProstRcision?

Answer:
We rarely see problems of any significance. The most common symptoms we see are irritation of pre-existing hemorrhoids. If a man has hemorrhoids, he may see spotting of blood, especially after a hard bowel movement. Stool softeners usually resolve this problem.

Question 129:
What is the worst complication that can occur after ProstRcision?

Answer:
The worst complication is a rectal fistula, which is extremely rare at RCOG, and no patient has developed a fistula in the past eight years. A fistula means development of a hole between the rectum and the urethra so that urine passes through the rectum. This is a very serious condition that requires surgery and a colostomy bag. Rectal fistulas have occurred after all treatments for prostate cancer, including after radical prostatectomy.

Question 130:
If a man has sexual problems after treatment for prostate cancer, can he use Viagra^®, Cialis^® or Levitra^®?

Answer:
Yes. There are two main factors that determine preservation of sexual function after ProstRcision: a man’s age and the quality of penile erection before treatment. For example, men with normal erection and age 50 or younger have a 94% chance of retaining sexual function, as compared to men age 76 or older with normal erection function, who have a 40% chance of keeping sexual function. If men do have problems with erection, they can use Viagra^®, Cialis^® or Levitra^®. From our database, we find that 38% of all men within five years of treatment use one of these medications at least occasionally, and the majority of these men achieve a better erection with use of these medications.

Question 131:
I have heard that radiation can cause cancer. Is there an increase in cancer, especially bladder or rectal cancer, after ProstRcision?

Answer:
With our database, we monitor development of other cancers in all men who we have treated with ProstRcision. We have not found any increase in cancer in men who have received ProstRcision. And especially, we have not found any increase in bladder⁷² or rectal cancer. Men who have received ProstRcision can develop other cancers including bladder, rectal, pancreas, lung or other cancers. However, the chance of men who have received ProstRcision developing other cancers is no different than what we see in the general population of men who have never been treated for prostate cancer nor received irradiation of any form.

Question 132:
What happens with most men after ProstRcision?

Answer:
ProstRcision has very little effect on most men. The day after the implant, men can travel, work, go to the gym or play golf. The most common effect is a weak urinary stream for a few months after the implant. If bothersome, men can control these symptoms with alpha blocker medication such as Flomax or Uroxatral. This is not a painful procedure, so pain medication is rarely needed except for Tylenol^®. Men typically have no rectal symptoms except for minor irritation if they have pre-existent hemorrhoids. Stool softeners are typically the only medication required for rectal symptoms. Except for men who have had a prior TURP (roto-rooter surgery) or severe urinary urgency, urinary leakage does not occur, and most men who are sexually active retain sexual function. Some men report a mild degree of fatigue for a few months after treatment. On a long-term basis, a few men will develop a temporary increase in urinary symptoms consisting of burning with urination and urinary urgency 18 months after the implant. These symptoms usually resolve within a short time. Problems from ProstRcision are rarely seen after 24 months.

Recurrence

Question 133:
The overall cure rate of ProstRcision is 83%, which means 17% are not cured. Why are they not cured?

Answer:
When we find a man with recurrent prostate cancer after ProstRcision (which means that his PSA did not fall to 0.2 ng/ml or eventually, his PSA rose above 0.2 ng/ml), we then determine where the cancer may be regrowing. Repeat tests are conducted, including bone scan, CAT scan and rebiopsying the prostate. We rarely find regrowth of cancer in the prostate. The recurrence rate in the prostate is less than 1%. Thus, we almost always destroy the cancer inside the prostate and microscopic capsule penetration with ProstRcision. Consequently, the most common reason we fail to cure men is because their cancer had spread elsewhere in their body before treatment and this spread was not detectable with tests before they received ProstRcision.

Question 134:
What do you do for men who develop recurrence of prostate cancer after ProstRcision?

Answer:
In the rare patient in whom we have found recurrence inside the prostate, men have been considered for salvage treatment by either radical prostatectomy⁴⁷ or cryosurgery.^56,57 Only one patient at RCOG has ever had a salvage radical prostatectomy. The cause for recurrence in almost all men after ProstRcision is because cancer spread before treatment with ProstRcision to other areas in the body, such as bone, lymph nodes or other places. If the PSA is rising very slowly, we just observe these men. Eventually, men are treated with hormones. Hormones do not cure prostate cancer but can typically suppress the cancer growth for many years.

Question 135:
Is RCOG the only treatment facility where ProstRcision is performed? If this is correct, why is ProstRcision not performed at other places?

Answer:
Yes, we are the only group in the United States that treats men with ProstRcision. However, we do know of other doctors who tried this approach and have had to stop using this treatment due to severe complications. Doctors have tried this method at the University of Missouri,⁷² in Copenhagen⁷³ and in Staten Island, New York,⁷⁴ but have since stopped using this technique because 3–10% of men developed fistulas requiring colostomies. The reasons these doctors stopped seed implant followed by beam radiation is because they were administering this technique differently than we do at RCOG. In sharp contrast, our rate of developing fistulas (see Question 129) is one of the lowest in the United States using any treatment method. This program, ProstRcision, is successful at RCOG because of the continuous research and study over the past 30 years. Consequently, men who are treated by our program receive the benefit of all the knowledge that has been accumulated at RCOG on these previous 12,000 men.

Summary

Question 136:
Please summarize your recommendations for men newly diagnosed with prostate cancer.

Answer:
The single most important thing to do is perform personal research on prostate cancer before you are treated. We strongly recommend that men employ the decision-making process detailed in this brochure:

Get a copy of your prostate biopsy pathology report and study it. This is the most important information about your own particular case of prostate cancer.
Get a second opinion on your prostate biopsy from a pathologist who is an expert in prostate cancer. If you wish, we can have this done for you.
Understand how prostate cancer works and the definition of cure (PSA 0.2 ng/ml), and focus on cure rates — not on treatment.
Consult with both radiation oncologists and urologists.
- Ask if they have a computerized database on all patients they have treated for prostate cancer.
- Ask for the 10-year ICR in writing for your particular case of prostate cancer from both urologists and radiation oncologists. Make certain the calculations are performed using PSA cutpoint 0.2 ng/ml.
- Ask for calculations of complication rates from their computerized database, especially urinary incontinence and loss of sexual function.

With members of your family, compare 10-year ICRs and complication rates from the different doctors you have visited.
Select the doctor and treatment method that give you the best chance of cure, with the least chance of complications.
Should you have any questions about this information, call or e-mail any of the doctors at RCOG

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Prostrcision

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Table of Cure Rates

Cure of prostate cancer: What Treatment Is All About

Personal Research

Evaluating Your Cancer

Biopsy Pathology Report

Curing Prostate Cancer

Individual Cure Rate

ProstRcision^®

Radical Prostatectomy

ProstRcision vs. Radical Prostatectomy

Definition of Cure

Comparing Treatments

Watchful Waiting

Hormones

Treatment Effects

Recurrence

Summary

References

ProstRcision®