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In a prior phase II study, the second-generation nonsteroidal antiandrogen agent enzalutamide significantly improved progression-free survival compared with the standard first-generation agent bicalutamide in men with metastatic or nonmetastatic castration-resistant prostate cancer (NEJM JW Oncol Hematol May 2016 and J Clin Oncol 2016; 34:2098).
Now, to test a similar second-generation antiandrogen agent in this setting, international investigators conducted an industry-sponsored, randomized, double-blind, placebo-controlled trial (SPARTAN) of apalutamide in 1207 patients (median age, 74 years) with nonmetastatic castration-resistant prostate cancer and high risk for metastasis. Patients had castrate levels of testosterone (<50 ng/dL) and a …