Increased risk of prostate cancer

The FDA has issued a somewhat controversial warning regarding an increased risk for high-grade prostate cancer associated with the 5-alfa reductase inhibitors finasteride (Proscar, Propecia) and dutasteride (Avodart, Jalyn). Ironically, the new warning stems from studies designed to evaluate whether the drugs offer protection against prostate cancer. Both drugs are marketed to treat benign prostate hypertrophy and both are known to significantly decrease the prostate-specific antigen levels. In separate studies, both drugs were investigated to see if they reduce the incidence of prostate cancer. FDA experts reviewed the results of the Prostate Cancer Prevention Trial (PCPT), which evaluated finasteride vs placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events trial (REDUCE), which compared dutasteride to placebo for 4 years. Prostate cancers were significantly reduced in both trials; however, the reduction was limited to low-grade prostate cancers with a Gleason score of 6 or lower. The rate of cancers with a Gleason score of 8-10 was increased in both studies. Previous analyses of these data have suggested that finasteride did not increase the risk of high-grade prostate cancers, but rather made them easier to diagnose by decreasing the volume of the prostate (Clin Cancer Res 2009;15:4694-4699; J Natl Cancer Inst 2007;99:1366-1374). The FDA panel, however, disagrees and feels it prudent to add a warning to labeling of both medications regarding increased risk of high-grade prostate cancer associated with use of the drugs. The guidance further recommends that prior to initiating therapy patients should be evaluated to rule out other urologic conditions, including prostate cancer, that might mimic benign prostatic hypertrophy.