Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

Official Title

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)


The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.

Trial Description

Primary Outcome:

  • Radiological progression-free survival (rPFS)
Secondary Outcome:
  • Overall survival (OS)
  • Time to castration-resistant prostate cancer (CRPC)
  • Time to initiation of subsequent antineoplastic therapy
  • Time to PSA progression
  • PSA undetectable rates (<0.2 ng/mL)
  • Time to pain progression
  • Number of participants with adverse events as a measure of safety

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society