CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,306 enrolled
Drug / intervention
BAY1841788 / darolutamide (ODM-201) +3 moredrug
Likely dose
Darolutamide 1200 mg daily (600 mg twice daily with food)AI-extracted
Key inclusion· 6
  • ✓Histologically or cytologically confirmed prostate adenocarcinoma
  • ✓Metastatic disease present
  • ✓Candidate for ADT and docetaxel treatment
  • ✓ADT started ≤12 weeks before randomization (with or without first-generation anti-androgen)
Key exclusion· 9
  • ✕Prior LHRH agonist/antagonist use
  • ✕Prior second-generation AR inhibitors (enzalutamide, ARN-509, darolutamide, other investigational AR inhibitors)
  • ✕Prior CYP17 enzyme inhibitors (abiraterone acetate, ketoconazole) for prostate cancer
  • ✕Prior chemotherapy or immunotherapy for prostate cancer

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

Search/NCT02799602
NCT02799602Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

Bayer·interventional·Posted Jun 15, 2016·Updated Dec 4, 2025

In Brief

A Phase 3 clinical trial evaluating BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), and 2 other interventions for Metastatic Hormone-sensitive Prostate Cancer. Completed, enrolled 1,306 participants across 322 sites in 23 countries.

Detailed Summary

The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Hormone-sensitive Prostate Cancer
CountriesAustralia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Finland, France, Germany, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
CollaboratorsOrion Corporation, Orion Pharma

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 15, 2016
Enrollment StartNov 30, 2016
Primary CompletionOct 25, 2021
Study CompletionApr 11, 2023
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 10.0 years ago

Interventions

BAY1841788 / darolutamide (ODM-201)drug

600mg (2 tablets of 300 mg) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total a daily dose of 1200 mg in addition to standard ADT (luteinizing hormone releasing hormone (LHRH) agonist/antagonist or orchiectomy) and 6 cycles of docetaxel

Standard ADT (androgen deprivation therapy)drug

As prescribed by the treating physician.

Docetaxeldrug

As prescribed by the treating physician.

Placebodrug

Placebo matching darolutamide (ODM-201) tablets in appearance, bid orally with food, in addition to standard ADT (luteinizing hormone releasing hormone \[LHRH\] agonist/antagonist or orchiectomy) and 6 cycles of docetaxel.