An important statement from the prostate cancer advocacy community


Prostate Cancer International, the parent of The “New” Prostate Cancer InfoLink, is one of several major US prostate advocacy organizations that came together to issue a joint statement this morning. The statement is in response to the publication of two articles on screening for prostate cancer, which appeared last week in the New England Journal of Medicine.

A JOINT STATEMENT FROM AMERICA’S PROSTATE CANCER
ADVOCACY, EDUCATION, AND SUPPORT ORGANIZATIONS

Since 1993, when the PLCO trial was started, we have awaited the results of this trial with eager anticipation, as have others. The initial report of the results of this study — and those of a comparable European trial — published last week in the New England Journal of Medicine have told us two things:

  • The studies offer conflicting evidence about the possibility of a prostate cancer-specific survival benefit associated with the regular use of prostate specific antigen (PSA) testing and digital rectal examination (DRE).
  • These studies provide no convincing evidence that mass screening of men over 50 or 55 years of age will lead to a prostate cancer-specific survival benefit within 10 years.

We have come together to make two clear statements about these trials:

  • Above all we thank the patients, the investigators, and the national authorities that funded these two trials for their efforts. The development and implementation of these trials over the past 16 years has been an enormous commitment by all concerned.
  • We enthusiastically support the continued follow-up of patients in the prostate cancer arm of the PLCO study for at least a further 5 years, through 2014, as originally envisaged.

In addition, in the long-term interests of the health of every man in the USA, and with health reform recognized as a national priority, we wish to state the following:

  • Every man, regardless of his age, has the right to know whether he is at risk from prostate cancer, a disease that still kills over 28,600 American men every year, and many more around the world. We encourage all men to be proactive, and to seek out information and support in regard to their health.
  • We shall continue to encourage every man to discuss his individual risk for prostate cancer with his doctors, and to request the appropriate use of PSA and DRE tests until better options are available. Further clinical action based on results of these tests is also a matter for serious discussion between each patient and his physicians.
  • We call upon the federal government to emphasize the need for more research into early detection technologies and methods that will lead to better and more accurate diagnosis of prostate cancer.
  • We call upon Congress to increase funding for the Prostate Cancer Research Program at the Department of Defense.
  • We call upon the National Institutes of Health to increase funding for prostate cancer research through the National Cancer Institute.
  • We call upon the medical research community to place greater emphasis on the development of new clinical tests that can differentiate between those men at greatest need for aggressive prostate cancer treatment and those with indolent forms of the disease who can be well managed without invasive treatment.

The statement above was approved by Prostate Cancer International and by the other following US-based prostate cancer advocacy, education, and support organizations:

29 Responses

  1. The above statement was also approved by George A. Brown, a prostate cancer survivor.

  2. I applaud your statement. In clinical research, failure to reject the “null” hypothesis does not imply that it has been proven. They authors have not proven that there is no value in these early detection tests; they merely have found that their methods failed to detect such benefits. This does not mean that the benefits do not exist. The results can only be used to refine the methods of investigation. The fact is that undetected prostate cancer is a killer and early detection can save lives and life styles. Better research is warranted to find effective methods for early detection.

    Thank you for your advocacy work.

    A friend of prostate cancer survivors and fatalities.

  3. Men deserve to know what they getting themselves into. Great to see that the statement includes:

    “Further clinical action based on results of these tests is also a matter for serious discussion between each patient and his physicians.”

    By the same logic, shouldn’t the statement also include provision that ‘Every man, regardless of his age, before beginning regular DRE exams and PSA testing, has the right to know that the latest studies:

    ” … offer conflicting evidence about the possibility of a prostate cancer-specific survival benefit associated with the regular use of prostate specific antigen (PSA) testing and digital rectal examination (DRE).
    … provide no convincing evidence that mass screening of men over 50 or 55 years of age will lead to a prostate cancer-specific survival benefit within 10 years.”

    Is there a reason that the statement does not call upon medical practitioners to do anything at all, but aren’t they the ones who are going to have to do things differently for anything to really change?

    Has anything changed at all since Dr. Carroll published an editorial in the Journal of Urology in 2005 under the heading, “Early Stage Prostate Cancer: Do We Have a Problem with Over-detection and Overtreatment or Both?

  4. Perhaps the most important omission from this statement is the fact that PrCa is a slow growing cancer — even in its aggressive form; for that reason we often see close to 100% 5-year survival rates for most forms of treatment.

    The original study was designed for 15 years — as the statement does indicate. The danger of releasing these intermediate results is that the medical community, particularly primary care physicians, will draw the wrong conclusions.

    Early detection DOES save lives as the European study correctly indicates. It is no coincidence that US experience reflects the same 20% reduction in the annual death rate from prostate cancer since the introduction of widespread PSA testing in the mid-1980s.

    As prostate cancer advocates, we need to press for continued testing while still researching better indicators of aggressive forms, and continue to stress the benefits of active surveillance.

  5. It was so refreshing to see a “Joint” statement by many of our prostate cancer support organizations. We need even more such joint working together to bring awareness of our men’s disease and encouragement for increased funding for prostate cancer research. The only added statement that I had hoped to see but was absent in the above would have been:

    “We call on physicians who determine the presence of low grade prostate cancer to thoroughly explain to patients all treatment options including active surveillance to preclude an unnecessary rush to more invasive treatment.”

    Or words to that effect. In my opinion, the “over-treatment” that has been so emphasized in recent media reports is the result of urologists and radiation oncologists urging men with low grade (Gleason 6, only one or two biopsy tissue samples evidencing low percent prostate cancer) to immediate surgery or radiation with no explanation/recommendation for active surveillance.

  6. The PSA is a biomarker and does not determine whether there is prostate cancer. The DRE and PSA combined do not tell you if you have prostate cancer. ONLY the biopsy identifies PCa.

    We need better imaging so the biopsy needles can be directed to tumors. Most other cancers would love to have a simple blood test as a biomarker.

    There is no such thing as over-diagnosis. You either have cancer or you don’t. Men deserve to know.

    There is a issue of over-treatment. Once we learn to discriminate between a “tiger” and a “pussy cat,” we can better direct treatment.

    I would not be here today if it were not for the PSA!

  7. The numbers that result from the whole course — testing to treatment — need to make sense, and these studies just provide more data that show that they don’t. Sorry, but this is just a subset of the conclusions that the USPHTF drew last year.

    Until our doctors can image and treat early stage cancers in less morbid ways, they will continue hurt more men than they help.

  8. This survivor also approves of the Statement. I do not agree that a man considering being tested should be told about conflicting results from a complex, confusing and incomplete project. The average man is not equipped to make a judgment on such a research project. I would hope that the doctor would be a filter for the results and inform that particular man in a way that he can absorb and understand the options open to him.

    To repeat what has already been said: “over-diagnosis” is a meaningless word and “over-treatment” is a result of faulty decision-making, not of the test itself. There is old adage in the trades: “It is a poor workman who blames his tools.”

  9. “The average man is not equipped to make a judgment on such a research project.”

    … and the average advocate has no right to make that man’s decisions for him after withholding information.

  10. I agree wholeheartedly that PSA testing and DRE are the only tools we have at this time to help us screen men for prostate cancer. And although most forms of prostate cancer are slow growing and not an immediate threat to most men’s health, what about those men who have aggressive forms of the disease? Do we eliminate the only way to screen them because one or even two studies give conflicting or inconclusive results? That would be ridiculous and irresponsible. Even if the tests are not the most reliable or accurate, they are the only tools we have at this time, therefore, we need to continue using them for screening purposes.

    My father was recently diagnosed with a very aggressive form of prostate cancer. Why was he diagnosed? He was having DREs and PSAs done every year because his father had prostate cancer that may have contributed to his death. My father’s cancer was found through these screening methods and he has started treatment due to this. I am sure he would have died within a year or two at the most had he not been screened, because he wouldn’t have known he had this aggressive cancer until he began having symptoms and by then it would have been too late to treat the cancer and hope for a cure. At this point, it is still early enough in the disease and he has no metastasis and can be treated and hopefully cured. This is why I support men continuing to be screened with PSA and DRE on a yearly basis after the age of 40!

  11. Dear Ms Lehmann: I don’t think for one moment that anyone would even want to suggest the elimination of regular testing of any man who has a clear and well-identified risk factor for prostate cancer, such as your father (and any brothers you may also have). That isn’t even an issue in my mind. What the controversy is about is the mass screening of men who have no known risk factors for prostate cancer.

  12. When I was diagnosed I was 44, Caucasian, and had no family history, but my PSA, taken by chance, was a tick below 20. After surgery I was pT3bN0Mx and Gleason 4 + 3. I ask just don’t subscribe to the “no testing” thought. I guess my timing was good after all. And to think I thought we got there late.

    Where there is such controversy, there is valid argument on both sides. Thus the need for more information is heightened. It is my hope that such controversy leads to better knowledge, understanding, and treatment.

    Until then, I side completely with this statement. Refreshing to see the teamwork that went into it.

  13. What the controversy IS about is what this web site is about: information.

    Men deserve to know what the facts are before they make decisions. Right now, in most states, you probably are obligated to be told more about a used car before you buy it than a doctor is required to tell you before he removes or destroys your prostate. Step one in the process leading up to that is usually a rather innocuous blood test that they’ve been doing for years — PSA — no big deal?

    I support PSA screening, but I think I and all other men deserved to know the big picture of the risks of prostate cancer screening, testing, and treatment before the first blood was drawn. If we then decline to deal with the information positively, then the outcome is on us. If the prostate cancer advocacy community continues to support organized denial of the known state of the medical art and scientific knowledge, then the onus is on them and their paternalistic attitudes.

  14. Dear Steve: I am confused by this statement, so I think others must be too. Most of us would discriminate very carefully between the prostate cancer advocacy community (meaning those whose primary intent is to act in the best interests of a man at risk for or with prostate cancer) and the prostate cancer diagnosing and treating community (i.e., physicians of different types). You seem to be lumping everyone into one bucket — but I don’t believe that was your intent!

  15. Mike,

    I understand what you’re saying and that’s an important distinction, but when the “JOINT STATEMENT FROM AMERICA’S PROSTATE CANCER ADVOCACY, EDUCATION, AND SUPPORT ORGANIZATIONS” failed to call upon medical practitioners to do anything at all, they weren’t acting in the best interests of men (all of whom are “at risk for or with prostate cancer”). Sorry, but the only conclusion I am able to draw is that they are supporting their own needs and those of the mainstream “diagnosing and treating community”.

    Alternate explanations would be welcome…

  16. Perhaps someone else would be so kind as to explain to Steve why the advocacy community is in no position to be able to tell physicians how to practice medicine. And even if we were, given the data from these trials, I have no idea what anyone could tell them to do except help each individual patient to come to the best possible decision for that patient. They should be doing that anyway!

    And Steve … I am very sorry but you are wrong when you suggest that all men are at risk for prostate cancer. The problem is that we don’t have to tools to tell who is and who isn’t! Just because I may have some cancer in my prostate does not place me at risk for prostate cancer (which is a clinical condition, not a pathological finding).

  17. I, too am a bit confused by Steve’s remark, “If the prostate cancer advocacy community continues to support organized denial of the known state of the medical art and scientific knowledge, then the onus is on them and their paternalistic attitudes.” Somewhere I must have missed something that would indicate the “advocacy community” …. “support organized denial….” of anything.

  18. “And even if we were, given the data from these trials, I have no idea what anyone could tell them to do except help each individual patient to come to the best possible decision for that patient. They should be doing that anyway!”

    And if that is what physicians were doing then I would understand confusion about Steve’s statement. But they are not, and that has been admitted numerous times even on this page, particularly regarding over-treatment (“the real problem”). Most physicians have far too much personal involvement to rationally respond to this controversy, not only financial, but emotional. No one wants to admit that they have likely done considerable harm with much less benefit than they realized. This is reflected in the reactions on the web to these studies from physicians. External oversight is needed in any profession to ensure that biases and self-interest do not negatively affect the practice of that profession. That includes medicine.

  19. Hi,

    A friend forwarded this info. I am a cancer survivor since October 2008. Would like to help people in Spanish or English.

    When it happened to me I was looking for months on the web and was abl;e to find nothing. Now I have the possibility to help people in similar conditions.

    Congratulation for the job done.

    I will be at the meeting on May 9th.

  20. These studies speak of survival statistics. Does any one know if they also recorded those who ended up being treated for cancer later and lived?

    I ask because my younger brother, who just had his cancerous prostate removed (in his late 50s), reacted to the studies by saying he would much rather have gone through what he did now than waiting and ending up with a much more aggressive course of treatments 10 to 15 years from now. Even though he would have been counted as “surviving” for the purposes of this study, therefore appearing to confirm the conclusions.

  21. Dear Mr. Symon: The two studies reported last week encompassed all patient treatments over the time frame of the studies, regardless of when the patient may have undergone such therapy. These were not active surveillance studies in which treatment was deferred. Each patient was treated (if he needed treatment) with therapy agreed between doctor and patient, as is customary.

  22. As a doctor (urologist) and a lawyer I learned that statistics in the courtroom regarding PSA and cancer of the prostate are disastrous for the defense. All the plainiff’s lawyer has to do to sway the jury is ask one question: “But it was 100% fatal for this patient, wasn’t it doctor, when he decided not to get a PSA on a routine annual physical examination because it was not recommended following a national study?”

  23. Dr. Demos,

    I don’t think anyone has said that doctors should stop recommending PSA testing for most men. I said that: “Men deserve to know what they getting themselves into” before starting the chain of events that can lead from PSA screening to radical surgery. Currently, I don’t think most men get more than a, We’re adding a PSA to your yearly blood tests now that you’re 50.”

    The Joint Statement thanks those making the referenced studies, and then goes on to essentially endorse “business as usual” and call for further studies. Will they ignore the results of these further studies as well if they don’t particularly like the conclusions drawn?

    Is this just prequel to the release of the results of the PIVOT study? Is the above statement the rough draft of how they will respond to whatever conclusions that study draws?

  24. WHAT’S WRONG WITH THE PSA TEST

    Prostate cancer is much akin to a turtle and a rabbit in an open box. The turtle, the indolent, non-aggressive cancer, wanders around the box, while the rabbit, the potentially aggressiveness cancer, hops around and might at any time jump out of the box. Thus, while we can diagnose prostate cancer, we cannot distinguish which cancer is the turtle and which is rabbit, and which needs treatment. More men die with prostate cancer than die because of prostate cancer.

    PSA is a normal component of the prostate. It is not specific for cancer. Rather it is present in the normal, benign, and cancerous prostate. The PSA test is therefore not the best tool we have for early diagnosis as some of the self-anointed “experts” continue to preach. The ability of the PSA test to identify men with prostate cancer is slightly better than that of flipping a coin. Prostate cancer is an age-related disease; a PSA test merely precipitates a biopsy. Depending on the age of the biopsied individual, and “… how hard [the cancer] is looked for,” (see Welch et al.), he may or may not be found to have cancer; in which case, if he has cancer, we cannot determine if it is a turtle or a rabbit!

    The manufacturers of the PSA test sold the urological community on a test that cannot detect what it purports to detect, i.e., prostate cancer, and the media have conveyed to the average man that current treatments work. If the later is true, why do 25-35% of men with localized prostate cancer have a recurrence within 5 years? We have bought into the cultural myth that doing more is doing better! In the case of prostate cancer, doing less may be better, although men with a family history of prostate cancer or those with symptoms should be more aggressively monitored by their physicians.

    By the way, I discovered PSA in 1970, and while in many cases, PSA is an indicator (“harbinger”) of recurrence of disease following treatment, it is not cancer-specific and cannot, in the manner in which the PSA test is currently used, be a screen for prostate cancer.

  25. No argument from us Dr. Ablin — except that we would suggest that the urology community was highly complicit in the uptake and use of the PSA test.

  26. Interesting that if “25-35% of men with localized prostate cancer have a recurrence within 5 years” one can say that cancer was not worth catching in the first place — possibly with a PSA test. Might the PSA of this cancer have been 10 ng/ml or higher? And if so, would the physician dismiss this elevation as not worthy of concern? If treatment failed, that must have been some aggressive cancer.

    I thought his interesting:

    I noticed a posting on a support list by a urologist who is also a lawyer who made note that at trial the defense would cringe when the plaintiff’s attorney announced to the jury that his client was not made aware that a simple PSA blood test would have determined that his client had developing prostate cancer and could have saved his life. And by his client’s physician failing to make this test available to his client, his client now has prostate cancer that has metastasized into his system, has caused extreme pain and loss of quality of life, and his client can now anticipate an early and painful death due to his physician failing to offer what could have been a life-saving simple blood test. Can you imagine the sizeable amount of “damages” that would most likely be awarded the plaintiff?

  27. A little-noted aspect of this study would seem to indicate that — in the US — patients who get PSA screening are more likely to die of prostate cancer at 7 years out, and no benefit after 10 years:

    From the New York Times:

    “The American study, led by Dr. Gerald L. Andriole of Washington University, had a single design. It found no reduction in deaths from prostate cancer after most of the men had been followed for 10 years. Every man has been followed for at least seven years, said Dr. Barnett Kramer, a study co-author at the National Institutes of Health. By seven years, the death rate was 13 percent lower for the unscreened group.”

    It seems to me that the inescapable conclusion is that the treatment that prostate cancer patients receive in the US is making their condition worse, at least in the short run. And this is without considering the other life-changing effects of treatment, or measuring the effect on overall mortality.

    I wonder if anyone can interpret this result in a more charitable way. How is it that it seems to have been unaddressed both in the press and in this joint statement?

  28. Dear Mr. Friedlander:

    The problem is that this supposed 13 percent “increase” in the mortality rate at 7 years is not statistically significant. Let me quote exactly what the paper itself states on this subject, from the very first paragraph of the results section:

    “At 7 years there were 50 deaths attributed to prostate cancer in the screening group and 44 in the control group (rate ratio 1.13; 95% CI 0.75 to 1.70). … Through year 10, with follow-up complete for 67% of the subjects, the numbers of prostate-cancer deaths were 92 in the screening group and 82 in the control group (rate ratio 1.11; 95% CI 0.83 to 1.50). At 10 years, the median follow-up time was 6.3 years in the screening group and 5.2 years in the control group.”

    This difference of 6 deaths at 7 years, while numerically equal to 13.6%, is not actually statistically meaningful and cannot be interpreted to be a “real” difference between the two death rates because it could have just occurred by the “law of averages.”

    The statistical analysis of studies like this is complicated, and I certainly don’t mean to imply that I have great expertise in this area, but I do know enough to understand that a “rate ratio” of 1.13 with a 95 percent confidence interval of between 0.75 and 1.70 is nowhere near to statistically significant.

    For the same reason, the “increase” in the number of men dying of prostate cancer in the screening arm of the trial at 10 years (92 – 82 = 10 = 12.2%) is also not statistically significant. This lack of statistical significance relates to the very small numbers of men actually dying of prostate cancer at 7 and 10 years compared to the numbers of men in the trial (nearly 77,000). At 7 years exactly 44/38,383 men in the screening arm (0.13 percent) and 50/38,350 men in the control arm (0.13 percent) had actually died of prostate cancer.

    You should bear in mind that the original trial was designed to run for 15 years before any results were made available. I am still uncertain why the data from the American trial got published at this time — but I have a suspicion that once the results of the European trial were known, it became almost impossible for people not to publish the available data from the US trial simultaneously (a scientifically and medically political decision which was not necessarily in the best interests of those at risk for prostate cancer).

    Finally, if you look at Figure 1B in the actual paper, which tracks the number of prostate cancer deaths against the actual time period for which each patient had been followed, you will see that the curves overlap each other for the first 6.5 years. After that, they actually start to separate, favoring a very slight survival benefit in the screening arm — but it is still not statistically significant at 10 years, when only 67% of the patients had actually been followed for the full 10 years.

  29. The overdiagnosis and overtreatment of prostate cancer continues unabated, and will continue until this very common condition is called by another name. “Cancer” just carries too much emotional baggage to apply to a condition whose prevalence far exceeds its general threat to life and limb. I have suggested “Prostatic tubular neogenesis” as an alternative term, but my letter to the editor of the most prestigious pathology journal has never been published.

    My lab diagnoses about 40 new cases of prostate cancer each day. IMHO, a minority of men are appropriately treated. Active surveillance is underutilized, but is fortunately on the rise, as the new research continues to prove its utility for MOST men.

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