Men under active surveillance for low-risk prostate cancer benefit from adjunct dutasteride
TUESDAY, Jan. 24 (HealthDay News) -- For men with low-risk prostate cancer who undergo active surveillance, treatment with dutasteride delays the time to cancer progression, according to a study published online Jan. 24 in The Lancet.
Neil E. Fleshner, M.D., M.P.H., from the University of Toronto, and colleagues conducted a randomized, double-blind, placebo-controlled study to investigate the safety and efficacy of dutasteride, a 5α-reductase inhibitor, for men with low-risk prostate cancer. Participants with low-volume, Gleason score 5 to 6 prostate cancer, who chose to be followed with active surveillance, were enrolled and randomly allocated to receive once-daily dutasteride (144 men) or matching placebo (145 men). The time to prostate cancer progression was the primary end point.
The researchers found that, by three years, significantly fewer men in the dutasteride group (38 percent) had pathologic or therapeutic prostate cancer progression compared with those in the control group (48 percent) (hazard ratio, 0.62; 95 percent confidence interval, 0.43 to 0.89). Adverse event incidence was similar between the groups. Sexual adverse events, breast enlargement, or breast tenderness were seen in 24 percent of the dutasteride group and 15 percent of controls, and 5 percent in each group had cardiovascular adverse events. No prostate cancer-related deaths or cases of metastatic disease were observed.
"Findings from our study show that dutasteride could be a beneficial adjunct to active surveillance for men with low-risk prostate cancer, delaying their time to pathological progression and initiation of primary therapy," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including GlaxoSmithKline, which funded the study and manufactures dutasteride.
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