- Conditions
- Metastatic Hormone-sensitive Prostate Cancer
- Interventions
- BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel, Placebo
- Drug
- Lead sponsor
- Bayer
- Industry
- Eligibility
- 18 Years and older · Male only
- Enrollment
- 1,306 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2016 – 2023
- U.S. locations
- 58
- States / cities
- Chandler, Arizona • Tucson, Arizona • Beverly Hills, California + 52 more
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- Conditions
- Prostate Cancer Non-Metastatic, Castration-Resistant
- Interventions
- Darolutamide (Nubeqa, BAY1841788), Placebo
- Drug
- Lead sponsor
- Bayer
- Industry
- Eligibility
- 18 Years and older · Male only
- Enrollment
- 1,509 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2014 – 2021
- U.S. locations
- 55
- States / cities
- Homewood, Alabama • Anchorage, Alaska • Tucson, Arizona + 48 more
- Conditions
- Biochemically Recurrent Prostate Cancer
- Interventions
- Darolutamide (BAY1841788, Nubeqa), Placebo matching darolutamide, ADT
- Drug · Other
- Lead sponsor
- Bayer
- Industry
- Eligibility
- 18 Years and older · Male only
- Enrollment
- 985 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2023 – 2030
- U.S. locations
- 25
- States / cities
- Phoenix, Arizona • Duarte, California • Los Angeles, California + 18 more