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ARCHES: A randomized, phase III study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer

Journal of Clinical Oncology Nov 19, 2019

Armstrong AJ, Szmulewitz RZ, Petrylak DP, et al. - Researchers performed a multinational, double-blind, phase III trial, the ARCHES, to test enzalutamide (a potent androgen-receptor inhibitor) with respect to its efficacy and safety in metastatic hormone-sensitive prostate cancer (mHSPC). They randomly allocated (1:1) 1,150 men with mHSPC to enzalutamide (160 mg/day) or placebo, plus androgen deprivation therapy (ADT), stratified by disease volume and previous docetaxel chemotherapy. Findings revealed that a significant reduction in the risk of metastatic progression or death over time was achieved with enzalutamide plus ADT vs placebo plus ADT treatment in men with mHSPC, including those with low-volume disease and/or previous docetaxel. The safety analysis, performed in this study, appeared consistent with the safety profile displayed by enzalutamide in earlier clinical trials in castration-resistant prostate cancer.
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