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Recently, two large trials of the next-generation androgen-receptor antagonists enzalutamide (PROSPER; NEJM JW Oncol Hematol Oct 2018 and N Engl J Med 2018; 378:2465) and apalutamide (SPARTAN; NEJM JW Oncol Hematol Apr 2018 and N Engl J Med 2018; 378:1408) demonstrated a significant and clinically meaningful delay in the development of metastatic disease in men with nonmetastatic castration-resistant prostate cancer (nmCRPC) associated with relatively short prostate-specific antigen PSA doubling times (PSA DT). These results led the FDA to approve both agents in men with nmCRPC and to accept metastasis-free survival as a new approval endpoint.
Now, investigators have conducted an industry-funded, international, randomized, double-blind, plac…