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Darolutamide in nonmetastatic, castration-resistant prostate cancer

New England Journal of Medicine Apr 01, 2019

Fizazi K, et al. - In men with nonmetastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less, researchers assessed the effectiveness of darolutamide (a structurally unique androgen-receptor antagonist that is under development for the treatment of prostate cancer) for delaying metastasis and death. A total of 1,509 patients were randomly allocated to treatment, with 955 to the darolutamide group and 554 to the placebo group. According to this randomized, double-blind, placebo-controlled, phase 3 trial, metastasis-free survival was significantly longer with darolutamide among men with nonmetastatic, castration-resistant prostate cancer vs placebo. For darolutamide and placebo, the incidence of adverse events was comparable. There was no association between darolutamide and a higher incidence of seizures, falls, fractures, cognitive disorder or hypertension vs placebo.

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