Abstract

In ARASENS (NCT02799602), darolutamide (DARO) + androgen-deprivation therapy (ADT) + docetaxel significantly reduced risk of death by 32.5% (HR 0.68, 95% CI 0.57–0.80; P<0.001) vs placebo (PBO) + ADT + docetaxel in patients (pts) with mHSPC. We investigated clinical outcomes in prespecified stratification subgroups based on extent of disease and alkaline phosphatase (ALP), both known prognostic factors.

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