Trials / Completed
CompletedNCT04736199
Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 669 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Darolutamide (Nubeqa, BAY1841788) | Coated tablet, oral administration |
| DRUG | Placebo | Coated tablet matching Darolutamide in appearance, oral administration |
| OTHER | Androgen deprivation therapy (ADT) | Luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or orchiectomy |
Timeline
- Start date
- 2021-02-23
- Primary completion
- 2024-06-07
- Completion
- 2026-01-23
- First posted
- 2021-02-03
- Last updated
- 2026-02-27
- Results posted
- 2025-08-08
Locations
131 sites across 15 countries: Australia, Brazil, Canada, Chile, China, India, Latvia, Lithuania, New Zealand, Peru, Russia, South Africa, Spain, Taiwan, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04736199. Inclusion in this directory is not an endorsement.