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Based on the results of recent randomized trials, three novel antiandrogens — enzalutamide, darolutamide, and apalutamide — have been approved by the FDA for management of men with nonmetastatic castration-resistant prostate cancer (NMCRPC), defined as a prostate-specific androgen doubling time (PSA DT) of <10 months and the absence of metastases on CT imaging and bone scan. At the initial reports, all of the trials demonstrated highly significant improvements in the primary endpoint of metastases-free survival (MFS).
The prior industry-sponsored, double-blind, randomized, phase III PROSPER trial (NEJM JW Oncol Hematol Oct 2018 and N Engl J Med 2018; 378:2465), showed that, among 933 NMCRPC patients continuing to receive androgen-deprivation…