Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer.

ABSTRACT:

Background

Darolutamide is a potent androgen-receptor inhibitor that has been associated with increased overall survival among patients with nonmetastatic, castration-resistant prostate cancer. Whether a combination of darolutamide, androgen-deprivation therapy, and docetaxel would increase survival among patients with metastatic, hormone-sensitive prostate cancer is unknown.

Methods

In this international, phase 3 trial, we randomly assigned patients with metastatic, hormone-sensitive prostate cancer in a 1:1 ratio to receive darolutamide (at a dose of 600 mg [two 300-mg tablets] twice daily) or matching placebo, both in combination with androgen-deprivation therapy and docetaxel. The primary end point was overall survival.

Results

The primary analysis involved 1306 p

SUBMITTER: Smith MR 

PROVIDER: S-EPMC9844551 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature