Long-term consequences of finasteride vs placebo in the prostate cancer prevention trial

Joseph M. Unger, Cathee Till, Ian M. Thompson, Catherine M. Tangen, Phyllis J. Goodman, Jason D. Wright, William E. Barlow, Scott D. Ramsey, Lori M. Minasian, Dawn L. Hershman

Research output: Contribution to journalArticlepeer-review

28 Scopus citations


Background: Finasteride has been found to reduce the risk of low-grade prostate cancer but to have no impact on overall survival. The long-term adverse and beneficial consequences of finasteride have not been examined. Methods: We used a linkage between data from the Prostate Cancer Prevention Trial (PCPT) and Medicare claims. Patients were examined by randomized study arm (finasteride vs placebo for 7 years) for long-term consequences of the intervention, including cardiac, endocrine, and sexual dysfunction, depression, diabetes, and benign prostatic hyperplasia (BPH)-related events. To examine time to events, we used cumulative incidence and Cox regression, adjusting for covariates. All statistical tests were two-sided. Results: A total of 13 935 of 18 880 participants (73.8%) in the PCPT were linked to Medicare claims, withmedianMedicare follow-up assessment time of 16 years fromtrial registration. There were no differences between finasteride and placebo participants with respect to important baseline factors or amount of Medicare follow-up assessment time. Finasteride patients had a 10% higher risk of new claims for depression (hazard ratio [HR] = 1.10, 95% confidence interval [CI] = 1.01 to 1.19, P = .04) and a 6% lower risk of procedures for BPH-related events (primarily lower urinary tract symptoms; HR=0.94, 95% CI=0.89 to 1.00, P = .03). No other differences were found in rates of long-termconsequences of intervention in the two study arms. Conclusions: Finasteride use is associated with reduced need for procedures for relief of BPH-related events and a modest increase in depression. Overall, there is little need to worry about long-termnoncancer consequences of finasteride use in those who use it for treatment of symptomatic BPH, hair growth, or prevention of cancer.

Original languageEnglish (US)
Article numberdjw168
JournalJournal of the National Cancer Institute
Issue number12
StatePublished - Dec 1 2016

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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