Dutasteride reduces prostate cancer incidence in men at high risk

Dutasteride reduces the risk of biopsy-detectable prostate cancer by approximately one-fourth in men at high risk for the disease without increasing the risk of high-grade cancers, said Gerald L. Andriole, Jr, MD, at the American Urological Association (AUA) 2009 Annual Meeting.

These were some of the findings derived from the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial, a 4-year, international, multicenter, parallel-group study in which 8,200 men aged 50 to 60 years and with PSA levels of 2.5 to 10.0 ng/mL or aged >60 years and with PSA levels of 3.0 to 10.0 ng/mL were randomized to dutasteride or placebo. All men had a single negative prostate biopsy (6–12 cores) within 6 months before study enrollment, and prostate volume was restricted to 80 cc or less.

Over the 4 years of the study, treatment with dutasteride resulted in a 23% RR reduction in biopsy-detectable prostate cancer versus placebo (P
“One very reassuring part of the REDUCE trial; there was no increase in the high-grade tumors in the dutasteride arm, irrespective of whether we consider high grade to represent Gleason 7 to 10 or 8 to 10,” said Dr Andriole, chair of the REDUCE steering committee and chief, division of urologic surgery, Washington University School of Medicine, and director of the Prostate Study Center at Barnes-Jewish Hospital, St. Louis.

The rates of Gleason score 7 to 10 cancers were 6.8% in the placebo group and 6.7% in the dutasteride group; the rates of Gleason score 8 to 10 prostate cancers were 0.6% and 0.9% in the placebo and dutasteride arms, respectively.

More patients assigned to dutasteride experienced drug-related adverse events than those assigned to placebo (22% vs 15%; P
The study was funded by GlaxoSmithKline. Dr Andriole is a consultant for the company.