Background

While there have been dramatic changes in treatment options for patients with advanced prostate cancer over the past 5 years, perhaps the greatest change has been for patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Prior to February 14, 2018, there were no agents approved by the United States Food and Drug Administration (FDA) for men with nmCRPC. Since then, three agents have been approved (apalutamide, enzalutamide, and darolutamide, in chronologic sequence of approval). While approval was initially based on improvements in metastasis-free survival, the seminal phase III trials for each of these agents have now reported overall survival data.

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