Author(s): Wilt TJ, Macdonald R, Hagerty K, Schellhammer P, Tacklind J, , Wilt TJ, Macdonald R, Hagerty K, Schellhammer P, Tacklind J,
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Abstract OBJECTIVE: • To estimate the benefits and harms of 5-α-reductase inhibitors (5-α-RIs) in preventing prostate cancer. MATERIALS AND METHODS: • We searched MEDLINE and the Cochrane Collaboration Library through June 2010 to identify randomized trials. • We included articles if they examined 5-α-RI vs control, were ≥ 1 year in duration and provided clinical outcomes. • Our primary outcome was prostate cancer period-prevalence 'for-cause'. RESULTS: • Eight studies met inclusion criteria but only the Prostate Cancer Prevention Trial and the Reduction by Dutasteride of Prostate Cancer Events were designed to assess the impact of 5-α-RIs on prostate cancer period-prevalence. The mean age of enrolees was 64 years, 92\% were White, and mean PSA level was 3.1 ng/mL. For-cause prostate cancers comprised 54\% of all cancers detected in placebo-controlled studies. • Compared with placebo, 5-α-RI resulted in a 25\% relative risk (RR) reduction in prostate cancers detected for-cause [RR 0.75, 95\% confidence interval (CI) 0.67-0.83; 1.4\% absolute risk reduction (3.5\% vs 4.9\%)]. One BPH trial reported that the risk of prostate cancers detected for-cause was significantly reduced with dutasteride and combined dutasteride plus tamsulosin compared with tamsulosin monotherapy. • Six trials vs placebo assessed prostate cancers detected overall. There was a 26\% RR reduction favouring 5-α-RI [RR 0.74, 95\% CI 0.55-1.00; 2.9\% absolute risk reduction (6.3\% vs 9.2\%)]. There were reductions across categories of age, race and family history of prostate cancer. • One placebo-controlled trial of men that investigators considered at greater risk for prostate cancer (based on age, elevated PSA level and having a previous suspicion of prostate cancer leading to a prostate biopsy) reported that dutasteride did not reduce prostate cancers detected for-cause based on needle-biopsy but did reduce risk of overall incident prostate cancer detected by biopsy by 23\%[RR 0.77, 95\% CI 0.70-0.85; absolute reduction 16.1\% vs 20.8\%]. There were reductions across age, family history of prostate cancer, PSA level, and prostate volume subgroups. • Incidences of erectile dysfunction, ejaculate volume, decreased libido, and gynaecomastia were greater with 5-α-RI vs placebo. CONCLUSIONS: • 5-α-RIs reduce the risk of being diagnosed with prostate cancer among men who are screened regularly for prostate cancer. • Information is inadequate to assess the effect of 5-α-RIs on prostate cancer or all-cause mortality. • 5-α-RIs increase sexual and erectile dysfunction. © 2010 THE AUTHORS; BJU INTERNATIONAL © 2010 BJU INTERNATIONAL.
This article was published in BJU Int
and referenced in Journal of Cancer Science & Therapy