The prostate cancer prevention trial (PCPT) was a randomized, double- blind, placebo-controlled trial (n = 18,880) performed to evaluate the efficacy of the 5-alpha-reductase inhibitor finasteride (FIN) for prevention of prostate cancer. At the end of 7 years, the good news was a 25% reduction in total prostate cancer; the bad news was that there was a 27% increase in higher-grade prostate cancers, intimating that although the total amount of prostate cancer was reduced, overall outcomes could possibly be worsened by the increase in more aggressive cancers. Mitigating explanations for the increased risk of higher-grade tumors included alpha-reductase inhibitor-induced shrinkage of healthy prostate tissue (thereby increasing the likelihood of biopsy-positive results) and alteration of tissue architecture induced by FIN; insufficiently reassured by these explanations, most primary care clinicians have opted not to use FIN for prostate cancer prevention.
The outcomes of this population in very long-term follow-up can better answer the question of whether the risk-benefit balance was indeed unfavorably tipped by high-grade prostate cancers. Reviewing the outcomes of patients originally enrolled in PCPT, the survival rates at 18 years were essentially identical among men who had been randomized to FIN or placebo. Although FIN treatment did not appear to reduce mortality, the increased incidence of higher-grade Gleason scores among FIN-treated patients did not appear to increase mortality either. In the absence of mortality improvement, unless men are seeking alpha-reductase treatment for symptomatic benign prostatic hyperplasia, FIN treatment for prevention of prostate cancer would appear unwarranted, albeit otherwise safe.
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