Level-1 Data From the REDUCE Study and the PCPT Data

Given the high incidence of prostate cancer in men undergoing prostate-specific antigen (PSA)-based screening, two large prospective randomized double-blinded studies have been conducted for the purpose of evaluating the ability of 5-alpha-reductase inhibitors to reduce the risk of prostate cancer in these men. The Prostate Cancer Prevention Trial was conducted in men with low baseline PSA levels to evaluate the efficacy of finasteride versus placebo. Results demonstrated an overall significant risk reduction of the detection of prostate cancer, but there was an increased diagnosis of higher-grade disease in the treatment group. Subsequently, the Reduction by Dutasteride of Prostate Cancer Events trial (REDUCE) assessed the effect of dutasteride, a dual 5-alpha-reductase inhibitor, on the risk of detecting prostate cancer in men with elevated baseline PSA levels. Results demonstrated significant risk reduction for the development of prostate cancer with dutasteride use. There was no statistical difference in the development of higher-risk disease between men taking dutasteride and placebo.