OncRef

Clinical Trial: NCT02200614

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Bayer
Information Provided By:Bayer
Last Update Posted:2022-06-28

Study Overview

Brief 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.

Official Title

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

Conditions

Prostate Cancer Non-Metastatic, Castration-Resistant

Intervention / Treatment

  • Drug: Darolutamide (Nubeqa, BAY1841788)
  • Drug: Placebo

Other Study ID Numbers

  • 17712
  • 2013-003820-36

Start Date (Actual)

2014-09-12

Primary Completion Date (Actual)

2018-09-03

Study Completion Date (Actual)

2021-06-14

Enrollment (Actual)

1509

Study Type

Interventional

Phase

Phase 3