Study
| International, multicenter, phase 3 trial (ARASENS) |
| Metastatic, hormone-sensitive prostate cancer |
| Darolutamide (n=651) or placebo (n=654) with androgen-deprivation therapy and docetaxel. |
Efficacy
| Median treatment duration: 41 m vs 16.7 months |
| 4-year OS: 62.7% vs 50.4%, HR: 0.68 [0.57-0.80, p<0.001] |
| Time to develop castration-resistant disease: HR: 0.36 [0.30-0.42, p<0.001] |
Safety
| Grade 3 or 4 AE: 66.1% vs 63.5% |
| Neutropenia: 33.7% vs 34.2% |
N Engl J Med 2022; 386:1132-1142
Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer
http://doi.org/10.1056/NEJMoa2119115
Reviewed by Hasan Cagri Yildirim, MD on May 20, 2022
