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

> **NCT02200614** · PHASE3 · COMPLETED · sponsor: **Bayer** · enrollment: 1509 (actual)

## Conditions studied

- Prostate Cancer Non-Metastatic
- Castration-Resistant

## Interventions

- **DRUG:** Darolutamide (Nubeqa, BAY1841788)
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT02200614
- **Lead sponsor:** Bayer
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2014-09-12
- **Primary completion:** 2018-09-03
- **Final completion:** 2021-06-14
- **Target enrollment:** 1509 (ACTUAL)
- **Last updated:** 2022-06-28

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02200614

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02200614, "Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT02200614. Licensed CC0.

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