The Influence of Finasteride on the Development of Prostate Cancer

This chapter describes the design, main findings, relevance, and limitations of the landmark Prostate Cancer Prevention Trial (PCPT), which randomized men to finasteride versus placebo and followed them for 7 years. It found a major reduction in prostate cancer incidence but also a higher proportion of high-risk cancer in men diagnosed with prostate cancer. The study did not address the more important oncological outcomes of disease-specific and overall survival. Secondary analyses of PCPT outcomes favored the finasteride arm and suggested that the risk of high-risk cancer is not increased. Linkage analysis of participants from PCPT to Medicare claims data suggested no adverse long-term cardiac, endocrine, or sexual effects.