Dutasteride taken for two years may prevent biochemical progression of prostate cancer (PCa) in men who experience PSA failure after radical therapy, according to a study.
In a double-blind trial, Fritz H. Schröder, MD, of Erasmus Medical Center in Rotterdam, The Netherlands, and colleagues randomly assigned 294 PCa patients who had PSA relapse after radical therapy to receive dutasteride—a dual 5-alpha reductase inhibitor approved for treating benign prostatic hyperplasia—or placebo (147 participants in each study arm). A total of 187 patients (64%) completed 24 months of dutasteride or placebo treatment. Compared with placebo, dutasteride significantly decreased the risk of PSA doubling by 66% for the overall study period, the researchers reported online in European Urology. The drug also significantly delayed disease progression (which included PSA-related and non-PSA-related outcomes) compared with placebo, for an overall relative risk reduction of 59% in favor of dutasteride.
Of the 294 patients enrolled, 107 discontinued treatment prematurely: 71 (48%) in the placebo group, 36 (24%) in the dutasteride group.
The study arms had a similar incidence of adverse events (AEs), serious AEs, and AEs leading to study withdrawal. Investigators were not blinded to PSA levels, which they noted is a study limitation.