At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,509 enrolled
Drug / intervention
Darolutamide (Nubeqa, BAY1841788) +1 moredrug
Likely dose
Darolutamide (Nubeqa, BAY1841788) 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Darolutamide (Nubeqa, BAY1841788) and Placebo for Prostate Cancer Non-Metastatic and Castration-Resistant. Completed, enrolled 1,509 participants across 404 sites in 36 countries.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Colombia, Czechia, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Peru, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsOrion Corporation, Orion Pharma
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartSep 2014
Primary CompletionSep 2018
Study CompletionJun 2021
TodayJul 2026
First PostedJul 25, 2014
Enrollment StartSep 12, 2014
Primary CompletionSep 3, 2018
Study CompletionJun 14, 2021
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 11.9 years ago
Interventions
Darolutamide (Nubeqa, BAY1841788)drug
Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.
Placebodrug
Matching placebo 2 tablets twice daily with food.