Sunday, May 27, 2007

How to play the game with numbers!

How To Play The Game:

1. SCARDINO AND HIS FIGURES
2. GAME PLAYING AT ITS BEST
3. THE ACTUAL PROVEN NUMBERS


1. SCARDINO AND HIS FIGURES
In addition the only reason that Scardino figures are better than Walsh is the simple fact that he used a definition of failure that would give him better results. He has used 0.4 vs. Walsh 0.2. In addition he has used " Treatment failure was recorded when there was either clinical evidence of disease recurrence, a rising serum prostate-specific antigen level (two measurements of 0.4 ng/mL or greater and rising), or initiation of adjuvant therapy. "

But for discussion purposes let use just the difference in numbers between 0.2 and 0.4.

In the Mayo study:"DEFINING PROSTATE SPECIFIC ANTIGEN PROGRESSION AFTER RADICAL PROSTATECTOMY: WHAT IS THE MOST APPROPRIATE CUT POINT?"
Using the identical cohort of men they found that using a definition of failure of 0.2 they arrived at a 5 year figure of 62% and a ten year figure of 43% freedom from disease progression - with the same cohort they found that using 0.4 would give them a 76% freedom at 5 years and 61% at 10 years. Therefore by using this definition to equally the scores based on 0.2 as Walsh uses we would have to subtract 14 points off of Scardino scores at 5 years and 18 points at 10 years. I now suspect that Scardino is a long way from Walsh.

Now if we use his 2nd convoluted way of defining definition of failure as per the quote above - Mayo found that by that definition (using the first date as time of failure) he arrives at even higher figures 82% at 5 years and 75% at 10 years BUT lets go one step further if he uses the second date as the failure date the figures are 86% and 61%. Lets see if we can get that in a chart:

Modification Factor Disease Freedom 5 Year 10 Year.
1. Nadir of 0.2 or less 62% 43%
2. Nadir of 0.3 or less 72% 54%
3. Nadir of 0.4 or less 76% 58%
4. Nadir of 0.5 or less 78% 61%
Nadir of 0.4 with 2 rises
5. Using 1st date of rise 82% 75%
6. Using 2nd date of rise 86% 61%
ASTRO (Official)
7. Official date of failure (1) 78% 78%
8. Modified date of failure (2) 85% 59%

2. GAME PLAYING AT ITS BEST
Now lets play games:

Assume I am a surgeon and I am about to make a report of my results at 5 years. I look at the chart above and decide that at 5 years the best definition for me to use is number 6 above and I can show a disease freedom rate of 86%. Now I accumulate data for another five years and decide to make another study and I again look at the data above and decide that this time I can get the best figures out of the ASTRO definition number 7 or even use a nadir with 2 rises (used that before) and this time use the 1st date of rise - line 5.

This is the manipulation that doctors go through - except for Walsh/JH (and some others) who more correctly uses anything over 0.2 is by definition a failure. No Mickey Mousing around - pure and simple. If you are doing a study with a minimum of 5 years of follow-up if you have a PSA over 0.2 than you have failed.

And now - compare Scardino against Walsh using adjusted figures so that we are comparing apples and apples.

3. THE ACTUAL PROVEN NUMBERS
What is really amazing and something that all should understand when reading studies or being told by a doctor his results - what is the definition of failure. In the chart above using the identical cohort of men one can achieve a range of 61% to 85% at 5 years and a range of 43% to 78% at 10 years. One can even get a 10 year figure that is better than a number of five year figures. It is a travesty of the medical doctors and there playing of statistical games for their benefit - and not for the patients benefit.

It is a game of numbers and you must understand the game. Read http://www.cancer.prostate-help.org/download/studies1.pdf for clarification. (This is a paper I have written trying to clarify how these numbers are used and what they mean. It is a rather lengthy paper - be prepared to spend some time in reading and understanding.)

In my estimation any doctor that does not use what the leading medical institutions (Johns Hopkins) for surgery uses - they are simply playing the game to get the best results they can - even though it may prove deadly for the patient. One can be slipshod and get excellent results by picking the right definition of failure. But who cares the doctors get great numbers!!! Maybe the patient should care - I did and understood this in 1997. I see no reason for differing definitions of failures for differing treatments. They all should be the same in the long term (at least 5 years minimum follow-up or even longer). All treatments will continue to fail 5, 10 and more years out. But the continuation of failure should be about the same using the same definition when you are looking at 5 and 10 year minimum follow-up.

There is no surgeon that we are aware of through published peer reviewed studies that can match the results of Walsh when figures are adjusted to a common definition of failure.

This adjustments can be made through studies like Mayo above and several others that I put online in my PDF file above. They are not made up - they are real figures as published in leading peer reviewed medical journals.

NOTE from Don Cooley - May 27, 2007:
The above was written some years ago and needs to be updated. However an updating would not change the actual figures to any great extent - if at all. In addition the PDF paper referred to is also in need of some updating and corrections.

Friday, May 25, 2007

Diagnosis - is it?

This is another one of those "the longer I have been involved with the groups and PCa, I have some strong feelings" type posts.

This one is about mono treatment of any kind, surgery, radiation, seeds, HDR, Cryo, etc., etc. I do not believe there is ever a time to risk mono treatment in the fighting of this disease. Let me list the reasons why.

1. To begin with the diagnosis itself is so uncertain in terms of the cancer in the gland, the Gleason. PSA and the staging - all very inaccurate.
A.
We get 6 or more needles put into a gland that may be anything from 20cc to 160cc in size. If we are talking about a 25cc gland then 12 needles cover it much more than 12 needles in a 100cc Gland. If 12 needles is sufficient for a 25cc gland then we should use 4 times that many needles for a 4 times larger gland to get the same coverage.
B. In addition there are areas of the Gland that a normal biopsy will not cover with even 12 or more needles.
C. Not all doctors are able to see the cancer in the gland and they put the needles in with a predetermined pattern. A skilled doctor looking at the gland will see areas that are suggestive of cancer and he will stick a needle in those areas. Then we have doctors who use a Color Doppler along with a Black and White that gives them an even better chance of seeing any cancer and sticking a needle in it. Now when we look at the totally needles and total positive the doctor who sees the cancer will have more positives and may do less other needles. Thus our guidelines may not apply to the biopsies done by that doctor.
D. Some tumors are so small that they can not be seen and a small chance of ever having a needle passing through them.
E. In any positive needle that maybe shows a Gleason grade of 3 - a fraction of an inch away may have been a 4 or even a 5.

The result of all this is uncertainty and confusion. Even with the very best doing biopsies we really do not know exactly what we have. So we begin this journey with something that may be just the tip of the iceberg.

2. There is a great deal of confusion about Stage.
What we usually want to know is what was the "clinical stage" - this is the stage when the doctor does the DRE and it is what he feels. The "pathological" stage is commonly thought to be the stage that is found when the gland is removed in surgery. About 50% of the time these will be different. Also the amount of the cancer that is found following surgery will be higher. And if you had 10 doctors doing a DRE they may feel 10 different things. So at best this is very iffy. Read about stage at Reference: 5 below.

3. And now for the Gleason score.
We know that better than 50% of the time the Gleason as given at your local clinic is wrong and it is usually lower than reported. Why is this - simply local pathologists do not have the experience in looking at prostate cancer slides and assigning a Gleason score. Then if we look at the gland following surgery we also find a large difference in what was reported from the biopsy. There is little chance that the Gleason that was assigned at the local level is, in fact, the Gleason you have. This is why we always insist the slides be sent to an acknowledged expert for review. Information at Reference 3, 4 and 5 below.

4. And then we have PSA.
PSA is caused by many things. When a biopsy decision is made base on the level of PSA it is wrong as much as 75% of the time - this means that they cannot FIND cancer in 75% of the men - does not mean it is not there just that they missed it! In prostate cancer PSA is almost a "fools paradise" because so many thing by controlling the PSA they are controlling the cancer - simply not true. We have studies that show the cancer continuing to grow as the PSA gets lower. For a better understanding of PSA and all of its ins and outs read the pages on PSA in the reference #5 below.

ARE YOU CONFUSED?
So we have a rather bleak and dismal look above at diagnosis and how inaccurate it can be and how unreliable the numbers you are given may be. The result of all of the above simply tells me that most are understaged and therefore should get treated as if they had a higher grade of disease.

The other thing that I so frequently see is those who have failed their initial treatment and the cancer has come back and they are in the fight for their lives - of which many will lose. As I view those who have advanced disease I note that an overwhelming majority of them has a mono treatment at the time of diagnosis. There are a few who were diagnosed with advanced disease and they go along and get treated and if it is a mono treatment - it is sure to fail.

And something else that has to be taken into consideration is the fact that the insurance companies have a set of rules that may dictate only a mono treatment because they simply will not pay for the combination. A practice that I believe is very short sighted on their part - in the long run it will cost them more. Since the doctors knows the insurance will not pay for it he/she has to convince you that the mono treatment is the best for you. They may be just signing your death warrant - especially if you might have a more advanced stage of this disease.

Therefore as I see it if you feel and your stats are such that you are convinced that you need treatment try always to get a combination for example surgery and radiation, seeds and external beam, and you can always add some kind of hormonal ablation therapy to any of them.

Now about that "do you need treatment" bit.
I believe there are times that one can get by without having any immediate treatment and perhaps some changes in the lifestyle and the addition of some supplements and meds may keep some control. This low grade cancer is sometimes referred to as "insignificant cancer". It is further defined as a low PSA, low Gleason, high %free PSA, very low stage, and someone past 65 with no family history of prostate or breast cancer.

If you have been given these numbers and you have checked and double checked them for accuracy (sent slides to an expert) and if you are willing to take a biopsy every year and be ready to move to an active treatment at any time those numbers change (and confirmed) - then you can consider Watchful Waiting.

The strange part of this is that frequently when one is diagnosed with "insignificant cancer" the doctor makes a recommendation for a mono treatment - WHY!!!! I personally believe that if your doctor recommends a mono treatment - you must check everything out carefully and see if you meet the qualifications of having no immediate treatment at all. If you do not meet these qualification then you need a combination treatment.

Even when we see men diagnosed with "insignificant cancer" we do see them start to fail and sometime, but rarely, quickly so you must be vigilant. For more information see References: 1 and 2 below.

Take Home
The take home of this long dissertation is simply that if you need treatment you should go all the way and have a combination of treatment. And if you think you qualify for a mono treatment - maybe you don't need treatment at all at this time!!!!

Now doctors are not going to like me for the above as it means loosing patients. They will simply say "what do you expect on the Internet". But remember that the survival rate for those who are diagnosed with localized cancer (including nodes and seminal vesicles) have a 100% success rate at 5 years. Other studies tell us that one can be as successful with WW out 15 years and at that time those who chose early treatment begin to be better off.

To successfully attack this disease and win the battle there are a number of steps that you need to go through and a lot of things you need to know about your history and your diagnosis. For more details go to the web site in Reference: 6 below and go through the step by step procedures. Then and only then will you have your full suit of armor on and ready to fight the battle.

References:
1. http://tinyurl.com/2apd97
2. http://tinyurl.com/2dm4oy
3. http://www.cancer.prostate-help.org/caglegr.htm
4. http://www.cancer.prostate-help.org/canames.htm
5. http://www.diagnosis.prostate-help.org/pcdiag.htm
6. http://www.diagnosis.prostate-help.org
And for everything prostate cancer start at:
7. http://www.prostate-help.org/




It is the patients decision!

I would like to discuss this disease as it gets into the advanced stage. This is a patient diagnosed with metastatic cancer or high Gleason, PSA, Stage that might indicate metastatic cancer - or at least possible micro-mets. Or a person who has failed his initial treatment and has a rising PSA. In both of these cases the prognosis is not good.

The question arises in both of these cases as to whether the treatments for this stage will lengthen the life of the patient and at what physical or mental costs. We have conflicting data on this but we believe that at least Hormonal Ablation Therapy (HT) will extend one's life but we have no long term studies comparing patients using or not using HT. But enough that has convinced us that this is the first treatment of choice in advanced disease.

We have to assume at some point in time the advanced patient will become refractory to HT and move on to secondary Hormonal Ablation Therapy and on to Chemotherapy. In this case, unless something else kills the patient first, prostate cancer will take the life of this patient at some time. For example we have few studies that show that any chemotherapy has an effect on the extension of life for anything other than a few months. Often times we go on a treatment protocol that keeps our PSA down for a few months and we look at that as an extension of our life - but is it really? Or is it just a few months that we might have had anyway. I don't think we know.

So now we have a question that only the patient should answer - not the wife, not the girl friend, not the doctor, not a friend - only the patient. That question would be how long do I want to stay alive and at what cost to my quality of life - is quality more important than quantity. When that answer has been made by the patient after deep thought and with full truthful knowledge as to where he is in terms of the disease - it is a killer disease. Whatever the answer is at that time may be changed later - the patient should not be pressured into sticking to that first decision. It is his body, mind and soul that we are talking about - no one else.

If we try to influence the patient by telling him everything is OK and we will fight it through until we find a cure. Are we doing a disservice to the patient when we know deep down and know that all the studies say that the disease is going to kill hum. Are we doing a disservice to that patient by talking him into Chemotherapy which the treatment may be worse than the disease at times. Are we doing a disservice to the patient telling him that diet and supplements are going to cure him or even help him. Are we doing a disservice to a patient to force him all over the country or even the world trying to find a cure when there is none.

I personally feel that a lot of the time that is exactly what we are doing. We must face reality - good or bad we must face it, live it, accept it and tell it like it is!

What do I feel we should do? Face the facts! Face the inevitable death from this disease in those high risk patients. And live for the moment.

I believe once a patient can honestly say to himself that this disease is going to kill me in time and this fact is accepted by those loved ones around him - a whole new life opens up for him and those loved ones. A new life and happiness that he may have never experienced before, a happiness and satisfaction with his self that sets in to bring many joyful things to him in those remaining years. A true happiness that many me who fight this disease every day of their life never reaches or even understands.

Away with the diet, away with the supplements, away with anything else that does not bring enjoyment to the patient. If none of these help, and we have evidence that they do not at this stage, why burden the patient with a bunch of nonsense and give him false hope. Additional treatment that might be worse than no treatment and with no proof they will extend his life - its his decision and his alone. Let the patient say - no more treatments - I want to enjoy the rest of my days to the fullest. Let the patient do things he always wanted to do but never had a chance. Fishing in Alaska - go for it. Cruise in the Caribbean - take it. Learn to sky dive - get the excitement. Give him the chance along with his loved one to enjoy every minute of his life to the fullest extent possible. Don't say you can't do something - he knows himself and he can make those decisions.

Stop pressing him and let him do what he wants to do to enjoy his remaining years. In the long run the family and loved ones will find they are all ahead in doing so.

Then when the time comes that the family can no longer care for him - get the help of Hospice. If he has gone through the above he will welcome the Hospice for himself and for those that will be helped in the care of him. And when the time comes all gather together in remembrance of all of the happy times together and give his permission to pass so he does so without anguish and regret.

At least this is the way I see it and I believe that this is the best thing we can do for the patient - make his remaining days happy days!

Friday, May 18, 2007

Radiation Burn and Other Cancers

First of all there is a lot of "horror" stories about the damage done to your body and other organs during radiation (of any kind) to the prostate. The prostate is located between the rectum and the bladder - both of which may get radiation. This is where the expertise of the Radiation Oncologist comes to play. With proper mapping and being able to follow the prostate when it moves is important to the overall cure and radiation burn of other organs.

The newer methods of external beam radiation are called IMRT (Intensity Modulated RadioTherapy). There are a number of "offshoots" of this but still in the same category. The fine control the doctor has of the beam is the clue. The doctor can take a wide sweep of the area in the hope of getting all the cancer or he can narrow the beam to include the prostate and exclude the surrounding area. This is not to say the surrounding area does not get radiation but simply to say that it only gets what might have spread from the radiation to the gland. However this is not usually enough to cause radiation burn or problems with urination, etc. But the skill of the doctor is all important here. The higher the skill the less damage to the surrounding area.

A little known fact among patients is that the prostate gland moves. It actually can move up to about 1cm in any direction at any time dependant on breathing, a full bladder, a full colon, etc. In addition to this movement patients frequently have undiagnosed ECP (Extra Capsuler Penetration) or ECE (Extra Capsuler Extension). These are little nubs that are cancer that is pushing out from the prostate gland itself. Now this is not necessarily a spread of the disease outside the local area (metastatic cancer) but it does show a good chance the cancer may have spread.

Therefore when the external beam radiation is done one has to allow for the movement plus any ECE. This means the beam has to spread over an area wider than the prostate gland - and this may mean radiating some of the other organs. This may well be an area where the doctor does not leave adequate beam around the gland and you get recurrence. If the doctor is experienced in giving radiation to the prostate area he knows where he can fudge and not give a full does and where he believes may leave side effects.

In the terms of Brachytherapy (seed implants, either permanent or temporary) you really have the best most precise radiation to the gland that is possible - radiating from the inside out. Again the expertise of the doctor comes into play. Simply if he does not have the experience to not place seeds in areas that will burn other organs - then he burns. It actually is a very complicated procedure to place adequate seeds where you have cancer and reduce the dose in areas not likely to have cancer. To me it is IMRT at its best but IMRT only applies to External Beam Radiation.

How can you know which doctor has the best (or worse) record of side effects. Unfortunately you can't unless the doctor has published, in a peer reviewed journal, his record along with his side effects. But most doctors will not do this - they simply tell you everything will be OK or they tell you nothing. Simply only take what the doctor says with a grain of salt - knowing that he will make money doing the procedure and that frequently is more important than telling the patient the facts. If he does not trace his patients for studies - he really does not know the facts. I know doctors who have published their results and yet in a meeting with patients they always say their results are around 10 points higher that the published paper. He knows that few will ever question and if they do - he has a canned presentation that would make the best talking salesman you ever met - seem like a novice. Don't ever forget that money drives this business at all levels.

Then you learn the problems after the procedure is done. Some doctors may measure these side effects differently. For example does being impotent mean that you can not get an erection, you cannot hold n erection, it takes Viagra or similar drugs to get an erection. Doctors may use any of these but usually in studies they decide you are not impotent if you can get an erection with Viagra or similar drugs or other mechanical means. To me, at least, my definition would be you are impotent if you cannot get an erection without aids of any kind that last long enough to complete the sex act with you partner. But this figure would be too high and the doctors want to lower the impotency rate so they dig up other definitions.

Only with studies published in peer reviewed journals do you ever know anything about the side effects of any doctor and the same goes for the results. If you are handed a slick brochure or white paper from your doctor giving you his results - ask them where they are published. If they are not peer reviewed published studies - they really are not worth the paper they are published on. Even when you read the full study and really understand the published studies and how they work - you may be mislead. Sometimes it seems the doctors are trying to confuse you with words, etc. to hide the real truth.

Now with all of this said it seems that we have some people who will burn more easier than others. These people may well report burns even with the best and most experienced of docs. Just because someone reports major problems they have had with a procedure does not necessarily mean that the doctor did a bad job. If you could find out how many had this problem you might be able to say "bad doctor" but this kind of doctor will never let you know how often he has bad results. They believe they are all experts on level with anyone else.

As for damage done that may cause other cancers later there is some evidence that this may be so - but the cancers that are caused are created many years out - years that many of us will be gone from other causes. To me this was so far outside that it was not a consideration when I chose to have Brachytherapy followed by External Beam Radiation.

Thursday, May 17, 2007

The "Artist" and who recommends

Let me ask some very simple questions to get a point across:

1. Have you ever had any member of any lists say anything but great things about their doctor and recommended him/her highly?
2. How much do you REALLY know about your doctor who treated you for you initial prostate cancer?
3. Web sites can be very impressive - why?
4. Why would you ever listen to patients that a doctor recommended to you?

1. ANSWER: The answer to the first question is it is VERY rare to have anyone say bad things about their doctor even when they failed the treatment the doctor gave them. There is a real "hero" worship for their doctor - even yet today.
2. ANSWER: The answer to the second question is that you really know very little other than what he/she has told you and very little about the truth of his long term results.
3. ANSWER: The answer to the third question is the websites are prepared by paid professionals who know how to sell any product - if they did not they would not be in business. The website is a SELLING tool first, last and always. It is ADVERTISING and should be given credit as such.
4. ANSWER: The fourth question answer is a no-brained - you should never listen to anyone on a prepared list that any doctor would give to you. Do you think for a minute that the doctor would give you a name of his patient that was unhappy with his treatment - no way!!!

Think about the answers to numbers 1 and 2 above when a patient of a doctor recommends the doctor to you. Think about the answer to number 3 when you are perusing a doctors or clinics or University web site. This is advertising and is no different than any advertising you see when you open your newspaper and see a Macy's ad or visit a website for Ford, General Motors, etc., for example. IT IS ADVERTISING and as such can be and many times is misleading. It tells you only what they want you to know. And question number 4 - not worth a discussion - forget it!!!

Basically all four questions should leave many doubts in your mind when looking for a doctor of substance.

In my "Artist" list (http://www.cancer.prostate-help.org/canames.htm) there are Urologists, Medical Oncologist, Radiation Oncologist, Color Doppler Experts, Cryo, Pathologist - all truly "Artist" by anyone's definition. They are published, they are leaders in their field, they are respected across the board for their knowledge. In some cases I have interviewed them, listened to presentations at national medical society meetings, read most all of their studies, etc. They have earned the right to be called an "Artist" for the work they have done in their medical communities AND the work they have done for their patients. They may not be all the most personable doctor there is nor have the best bed-side manners so you have to make a decision do you want expertise of bed-side manners. Personally the only thing I ever care about is the expertise of the doctor.

Let me note on thing - the writing of a book does not make one an "Artist" or an "Expert". It may be valuable information for the patient - slanted as it will always be but it is never considered when trying to add a doctor to my "Artist" list. I pay very little attention to what the doctors write in books - usually it is quite dated and almost always slanted to their view. Actually I put the books a step below good solid websites that can be updated daily.

It is these lists of "Artist" that everyone should start from and feel comfortable that you have made a wise decision if you decide they are the ones for you. It truly is your life you are playing with so spend you life wisely by making the right choices. If you have to travel - travel. If you have to dig deep in your pockets to pay - dig deep. But get the best available medical team that you can. For example my medical team was in San Francisco, Los Angeles, Atlanta and Detroit and I live in San Jose. This was 9 years ago when their was not a lot of information on the internet, not many groups, and little in the way of websites - none like Prostate-Help (http://prostate-help.org). The study I did then (5 months of study and two file cabinets full of papers and studies) was the beginning of seeking the best "Artist" available. The study continues to this day.

Did I do the right thing with the extent of the disease that I had - which could be classified as advanced localized disease (see http://mystory.prostate-help.org). The answer to that question is the fact that my PSA bounces around from 0.00 to 0.05 now since treatment in 1997.

Over the years I have removed some prominent doctors from these "Artist" list. Let me assure you they were not easily removed nor were they removed because of any patients complaints. They were removed because information came to me, usually from many sources, which made me question the skills, the practice, the procedures, and/or the purported results they may have published (or not published). Their removal was not from one single thing but from a series of things that happened over a period of time (some as long as 3 years) before I was comfortable with my removal decision. Believe me it is much easier to add someone to the list than it is to remove them and admit that I made a mistake. So I am especially careful about any removal - and such removal always creates a series of inflammatory posts from the patients as per number 1 above as well as reactions from the doctors involved.

And sure their may be and probably is many "experts" out there who are not on my lists. But I would say there is none better than those on my lists - and why not go to be best! I do add "Artist" as I make a determination they should be on the list - in itself not an easy decision.

Nuff said!

For the Ladies Who Care

Over the years I have created websites, mailing lists. forums, chats, etc. - but none really for the ladies that we love and who care for us. It always seems they were kind of left out and yet we know that they are a very important part of this disease. It is difficult for some ladies to talk about intimacy between the lady and patient who has prostate cancer and may well be suffering ED because of the disease. Here the Ladies can (and do) talk about everything in a Forum format. If you are a lady or your loved one is a lady - help her help you by having her join this Forum.

A PROSTATE CANCER FORUM FOR LADIES ONLY
Click here for information and joining the Ladies Only Forum. Now we have a Forum dedicated to those ladies who have a loved one with prostate cancer. Here the ladies support each other about the disease and the care for the patient as well as a discussion of various treatments. It is a on-of-a-kind Forum - the only prostate cancer Forum or Group for Ladies Only. If you are a lady and you have now or have had in the past a loved one with prostate cancer - this is the Forum for you. You can ask questions, discuss, hold each others hand, help others and learn about this disease.

Do the Doctors Manipulate Numbers?

Definition of failure: There are many definitions of failure used by different clinics and different definitions on each of their studies. It appears that with computers they can run their numbers with one definition and if the results do not make them happy - try another definition. This goes on until they find something they like and makes their studies look better than what they really are. (Back to our golf analogy: This is like saying that any ball within six inches, or a foot, or three feet, of the cup is in the hole! Most of us could improve our golf scores by changing the definition of "in the cup.")

Simply put, less stringent definitions of failure tend to result in a higher reported "cure" rate. As you read journal articles be aware of what definition of failure is being used, and how that is likely to affect the reported results.

During the past 10 years as I have read hundreds of studies. I decided that there had to be a way that we could find a common denominator in which we could weigh the various treatments and doctors. I researched every paper I could find that had anything to do with definition of failure for prostate cancer. In doing so I found the necessary data for me to come to some logical conclusions. Now I can look at any study and reduce it down, based on a PSA nadir of 0.2 at 10 years, and compare each of them side by side.

One of the more interesting developments is the use of the ASTRO definition (3). This definition was developed by the Radiation Oncology Society from data of patients who had prostate cancer and who were treated with radiation. However now other modalities of treatments outside of radiation, having realized the great benefit it makes to their figures, have started using the ASTRO definition. Using it in places where it was never designed for and has never been designed for or even tested for. It is in the process of changing yet today as I write this. I would guess they are looking for a better way yet to give them high scores.

Now we are finding that some studies are coming out with a bastardized manipulation of the ASTRO definition that adds things that were never there - and they still refer to it as the ASTRO definition. Undoubtedly this is being done to make results look better.

Who is included and who is not included in a study: Another way to "manipulate" the results of a study is through the definition of which patients are included in a study. What is an average golf score? If we include only touring professional golfers, we will come up with one answer. If we include All golfers who have ever played a round of golf, we will see quite a different answer. Which is the truth? They are both the truth, but based on a very different group of people. If we publish a prostate cancer paper that is based on men with stage T1c disease and Gleason scores of 5 or below, we will get a very different result than if we include all men that present with prostate cancer. Which is the truth? Which group do you fit into?

Look carefully at who is included in the study. Common things to look for: Including men (or at least too many men) in the study who have not been treated long enough ago to experience failure! Including men that can’t yet have failed is bound to increase the "cure" rate. (This is the main reason that studies of less than five years duration are not very useful, and may be just plain misleading.) Another is including only men who have the highest probability of success: Men with low Gleason scores for instance. That, too, will increase the "cure" rate reported.

There are many games to play, just be aware of who is included, and think critically about how this might affect the reported results. The ideal is a study that includes all comers: That is, all men treated at a facility irrespective of stage, Gleason score, etc. (No study is likely to have all comer’s because some refuse to participate by providing on-going information. Yet, a high percentage of those treated should be included.) Yet, there is even a caution here: Some clinics weed out men who are not likely to benefit from their treatment. That, too, will increase the reported "cure" rate.

Are Vitamins Killing Us?

I have held for a long time, as many may know, that there is scant evidence in long term studies that Vitamins, Supplements or Diet does much of anything once we have been diagnosed with cancer. My recommendations has been simply take one high quality multivitamin to supplement your diet, if your diet is lacking in these things. My recommendation has been to take the Vitamin pill with the largest meal of the day.

In the case of advanced disease it may be as much value to let the patient be happy with what he eats without restricting the diet or forcing pills down him. The happiness may give him just as long as anything else. Besides in this study giving a lot of vitamins may not be the thing to do.

There is some evidence that aspirin or ibuprofen might well be a preventative of prostate cancer if it is taken from the time of a young man until reaching the age that we see prostate cancer. There is some evidence that here may be other things that we can do along this line to prevent or delay prostate cancer. But even here we do not have a lot of long term studies to prove this and little to none where we use a double blind study.

Now comes a study at http://prostate-help.blogs.com/prostatehelp/2007/05/multivitamin_us.html with news articles at http://prostate-help.blogs.com/prostatehelp/2007/05/mega_multivitam.html and http://prostate-help.blogs.com/prostatehelp/2007/05/study_vitamins_.html that throws out the question that more than 7 doses of vitamins a week may well increase the number of deaths of men with prostate cancer. This is one rather well done study and we would like to see it verified by other studies and we will, in time, have these. With that said we have had previous studies showing that Vitamins and supplements have ltttle effect on this disease.

Some will say - listen to your doctor - but in this area the doctor may not be up on the latest studies and probably has no more experience than many of us in the use of vitamins. they have had little to no training in Medical School about diet and vitamins. In addition the thinking has changed so drastically in recent years the training they might have had is seriously out of date.

I believe it is of value to all men with prostate cancer to cut down on their use of Vitamins and supplements until we have more definitive studies in this field. We have had numerous studies that frankly has said that Vitamins are ineffective and a waste of money - but this is the first study that says we may be killing ourselves by taking large doses. I am not sure what the definition is for "large dose" but I would be very careful in taking more than what is needed to fulfill the minimum daily requirements.

Basically my thinking has not changed - but this study makes me more resolute to try to convince patients that Vitamins and Supplements do us any good and may, in fact, cause harm.