Words of wisdom. Re: Effect of dutasteride on the risk of prostate cancer. Andriole GL, Bostwick DG, Brawley OW, et al. REDUCE Study Group. N Engl J Med 2010;362:1192-202.

Author(s): Madersbacher S

Affiliation(s): Department of Urology and Andrology, Donauspital, Vienna, Austria. stephan.madersbacher@wienkav.at

Publication date & source: 2010-08, Eur Urol., 58(2):312.

Publication type: Comment

In this 4-yr, multicenter, randomized, double-blind, placebo-controlled study (REDUCE), the authors compared dutasteride 0.5 mg daily to determine the risk reduction of biopsy-detectable prostate cancer (PCa). Eligible men were 50-75 yr old, had a PSA between 2.5 and 10 ng/ml, and had one negative prostate biopsy (6-12 cores) within 6 mo before inclusion.Subjects underwent a 10-core transrectal biopsy at 2 yr and 4 yr. Dutasteride resulted in an absolute risk reduction of 5.1%and a 23% relative risk reduction with no increased risk for high-grade tumors. Men on dutasteride had a 77% risk reduction for acute urinary retention and a 73% risk reduction for benign prostatic hyperplasia (BPH)-related surgery but had higher rates for erectile dysfunction (3.3%), decreased libido (1.7%), and loss of libido (0.6%) and compared to placebo.