From the Office of Disease Prevention and the Office of Medical Applications of Research, National Institutes of Health, Rockville, MD
Author's disclosure of potential conflicts of interest are found at the end of this article.
Address reprint requests to Barnett S. Kramer, MD, MPH, Associate Director for Disease Prevention and Director of the Office of Medical Applications of Research, National Institutes of Health, 6100 Executive Boulevard, Room 2B03, Rockville, MD 20892-7517; e-mail: kramerb{at}od.nih.gov
Overview: The Prostate Cancer Prevention Trial (PCPT) reported a relative reduction in period prevalence of prostate cancer of approximately 25%, compared with placebo, for men treated for up to 7 years with the 5-alpha-reductase inhibitor finasteride. Concerns were raised at that time about the observed increase in high-grade tumors (Gleason scores 7 to 10) in the finasteride arm. This led to physicians being reluctant to discuss prostate cancer chemoprevention of with their patients. Subsequent analyses of the PCPT raised the possibility that the observed increase in high-grade tumors may have been spurious. Therefore, the American Society of Clinical Oncology (ASCO) and the American Urological Association (AUA) convened a joint panel to update the evidence and give guidance to physicians and the public on the balance of the benefits and risks of 5-alpha-reductase inhibitors for prostate cancer prevention. The panel felt that the increased risk of high-grade tumors associated with finasteride was more likely because of increased sensitivity of prostate-specific antigen (PSA) in detecting prostate cancer in men receiving finasteride rather than the initiation or promotion of high-grade tumors. However, the data are not definitive. The panel concluded that asymptomatic men with a PSA of 3 or less who are regularly screened with PSA could benefit from a discussion of the benefits of 5-alpha-reducatase inhibitors, as well as the potential risks (including the possibility of high-grade prostate cancer) of prostate cancer prevention. This manuscript will summarize the rationale for the conclusions recently published in detail elsewhere.
