ARASENS is an international phase III trial demonstrating the beneficial role of darolutamide, a novel antiandrogen, when added to docetaxel and androgen deprivation therapy (ADT), with improvement in overall survival in men with metastatic castration-sensitive or hormone-sensitive prostate cancer. Darolutamide is a nonsteroidal androgen receptor antagonist that has been previously shown to improve metastasis-free survival in nonmetastatic castration-resistant prostate cancer. ARASENS showed that the risk of death was 32.5% lower in those who received additional darolutamide compared to ADT and docetaxel alone. Darolutamide also improved other secondary endpoints including time to castrate-resistant disease, time to pain progression, time to first skeletal-related event, and subsequent initiation of therapy. ARASENS, therefore, shows that darolutamide, in addition to ADT and docetaxel, as a form of upfront systemic intensification of “triplet” therapy for patients deemed chemotherapy-fit, represents a new standard of care for men with metastatic hormone-sensitive or castrate-sensitive prostate cancer and is anticipated to further change the landscape of treatment for this population of patients.

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