Saturday, January 22, 2005

A Randomized Clinical Trial may tell us what to do... or not

Since it is believed that testosterone is involved in prostate cancer it seemed reasonable-biologically plausible-that a drug that inhibits the conversion of testosterone to dihydrotestosterone could decrease prostate cancer risk. So the Prostate Cancer Prevention Trial was instituted.18,000 men studied for seven years with the treatment group taking finasteride. Happily, there did seem to be a decrease in prostate cancer (a 24.8%decrease in prevalence in the seven year period of the trial) in the group given 5 mg. finasteride daily. However, there was an increased risk of high grade cancers in the finasteride group.37% of the tumors in the treatment group were Gleason grade 7 or higher versus 22% in the placebo group. The increase in high grade tumors was, of course,an unexpected finding.A decreased prostate cancer risk was expected-or hoped for- and occured. But now what advice would you give someone in regard to taking finasteride? Previously we could say finasteride could decrease prostate size and might decrease cancer risk.But now ...
"We have a drug that will decrease your risk of prostate cancer a bit but if you do get prostate cancer it may be a more malignant kind". Not a great offer.
For those who think RCTs give us clinical truth (and sometimes they probably do) the PCPT is a good example of how RCTs can make the clinical waters even more opaque.
Urologic science is undaunted. A new trial is planned (or possibly now underway). The REDUCE trial (J Urol.2004 oct:172 (4 pt 1) 1314-7) will enroll 8,000 men to take either placebo or a different 5 alpha reductase inhibitor,dutasteride for a projected 4 years.After the PCPT results what would you be able to say to eligible trial participants that would induce them to sign up? Well you do get free prostate biopsies and maybe this time there will be no surprises.

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