Prostate Cancer

New Indication: Darolutamide in Metastatic Hormone-Sensitive Prostate Cancer

2022-05-20

  • 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