A Message from Dr. Alan E. Shapiro, President
All good medical studies are prospective, that is, they start with a hypothesis, and treatment or no treatment are randomly assigned at the beginning of the study without bias, and no deviation is permitted, unless the study is discontinued due to an OBVIOUS benefit to switching a patient from the non-treatment arm to the treatment arm of a given study.
Though a classically trained urological surgeon, I have been an outspoken critic of treatment of Gleason grade 7 or less prostate cancer discovered on the basis of the PSA test alone. This blood test has limited value in that can uncover truly advanced prostate cancer. Conversely, the PSA blood test is unproven by any prospective study to be a prostate cancer diagnostic test or especially to be a test to direct treatment in men in their 40’s, 50’s and 60’s. What makes this fact especially tragic is that accepted radiation or surgical treatments renders ALL men sexually less than they were before treatment and many men significantly incontinent of urine, which is even a bigger disaster. Johns Hopkins surgeons have shown that 35% of their own surgically treated patients with this commonly treated level of cancer are in fact not really cured but are “controlled.” Does this justify treatment or does it beg the question did they need to be operated upon in the first place?
There is an unproven global bias that early discovery of ALL cancer is the only way to save lives. This MAY be true in some few cancers, but I submit that it is patently unproven in prostate cancer.
I have been gratified to see a shift to making the PSA “normal” number increasing to 10-15 instead of the widely accepted 4 number used for the last 20 years which ridiculously low commonly found “normal value” in men has led to much impotency and incontinence in men treated “too early” for Gleason grade 7 or less prostate cancer. A well- meaning researcher has advocated deciding on who gets treatment based on a PSA of 10-15 and Gleason grade 6 cancer and thereafter the rate of PSA doubling time with a minimum of 3 determinations over 6 months to help make the decision. Certainly this is a step in the right direction and a tacit assumption on his part, that early treatment is NOT NECESSARY in many or even most cases.
Remember, when the doctor comes out of the operating room and says, “we got it all” it is an assumption that we have the power to say that no “spread” will occur. This is also an unproven assumption. Control of something that doesn’t need to be controlled is overtreatment. I submit that most of the time, this is the case. We like to think that we, patients and doctors, have much more control of outcomes than we usually do.
In my 40 years of experience as a urological surgeon, almost all of those who have died of prostate cancer have horrible feeling prostate cancers the first time I examine them. These are ones whose lives we are prolonging not by surgery or radiation, but by hormone manipulation, i.e. medical or surgical castration which has been used for 70 years. It is, in my opinion these men who have benefited by the press barrage about prostate cancer, rather than those men who have early detection of early disease that has lowered the number of overall deaths from cancer. These latter men until we have a true prospective study of the kind I propose, (and I fear we will never get due to economic and legal incentives) will continue to lose their manhood and their urinary continence.
Please, understand, I am not advocating hormone treatment except for those whose PSA is 25-50 or more or whose prostate is obviously cancerous on rectal examination. What I am advocating is skillful neglect of a PSA (confirmed!!) of less than 20 or better yet, refusal of the patient with PSA in the 10-25 range to have a biopsy if the urologist, after referral for a confirmatory rectal exam does not feel something that he is SURE is cancer.