(ChemotherapyAdvisor) – In men undergoing active surveillance for low-risk prostate cancer, dutasteride delayed disease progression, according to a study in The Lancet published online January 24, 2012.
“Dutasteride could provide a beneficial adjunct to active surveillance for men with low-risk prostate cancer,” wrote Neil E. Fleshner, MD, MPH, of the University of Toronto and colleagues in interpreting the results of the first randomized study to investigate the potential benefits of a 5α-reductase inhibitor to delay time to treatment or pathological progression in men undergoing active surveillance for low-risk prostate cancer.
The double-blind, placebo-controlled, multicenter REDEEM (Reduction by Dutasteride of Clinical Progression Events in Expectant Management) trial randomly allocated 302 men to once daily dutasteride 0.5mg or matching placebo. Men were aged 48–82 years with low-volume, Gleason score 5–6 prostate cancer who had opted to be followed up with active surveillance. Each had 12 core prostate biopsy samples obtained after 18 months and 3 years.
Primary analysis included 289 men with at least one biopsy procedure after baseline. Primary end point was time to prostate cancer progression, defined as number of days between initiation of dutasteride or placebo and the earlier of pathological progression or start of medical therapy, considered surrogate markers of progression. By 3 years, 54 (38%) of 144 men who received dutasteride and 70 (48%) of 145 controls had prostate cancer progression (HR=0.62; 95% CI 0.43-0.89; P=0.009).
Sexual adverse events (AEs) or breast enlargement or tenderness was reported by 35 men (24%) in the dutasteride group and 23 (15%) in the control group; 8 (5%) and 7 (5%) had cardiovascular AEs, respectively. No prostate cancer-related deaths or metastatic disease were observed.
“A greater proportion of men who received dutasteride rather than placebo had subsequent prostate biopsies that were no longer positive for cancer, and dutasteride-treated patients had less prostate-cancer anxiety and fear of recurrence,” the investigators wrote.