CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 669 enrolled
Drug / intervention
Darolutamide (Nubeqa, BAY1841788) +2 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically or cytologically confirmed adenocarcinoma of the prostate
  • ✓Metastatic disease at baseline
  • ✓ADT (LHRH agonist/antagonist or orchiectomy) started within 12 weeks before randomization, with or without first-generation anti-androgen
  • ✓ECOG performance status 0, 1, or 2
Key exclusion· 11
  • ✕Prior use of second-generation AR inhibitors (enzalutamide, darolutamide, apalutamide, or investigational AR inhibitors)
  • ✕Prior CYP17 enzyme inhibitor (abiraterone acetate or oral ketoconazole) for prostate cancer
  • ✕Prior chemotherapy (including docetaxel) or immunotherapy for prostate cancer
  • ✕Systemic corticosteroid dose >10 mg prednisone equivalent per day within 28 days before randomization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04736199
NCT04736199Phase 3Completed
CompareCT.gov

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)

Bayer·interventional·Posted Feb 3, 2021·Updated Feb 27, 2026

In Brief

A Phase 3 clinical trial evaluating Darolutamide (Nubeqa, BAY1841788), Placebo, and 1 other intervention for Prostatic Neoplasms. Completed, enrolled 669 participants across 131 sites in 15 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms
CountriesAustralia, Brazil, Canada, Chile, China, India, Latvia, Lithuania, New Zealand, Peru, Russia, South Africa, Spain, Taiwan, Ukraine
CollaboratorsOrion Corporation, Orion Pharma

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedFeb 3, 2021
Enrollment StartFeb 23, 2021
Primary CompletionJun 7, 2024
Study CompletionJan 23, 2026
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.4 years ago

Interventions

Darolutamide (Nubeqa, BAY1841788)drug

Coated tablet, oral administration

Placebodrug

Coated tablet matching Darolutamide in appearance, oral administration

Androgen deprivation therapy (ADT)other

Luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or orchiectomy