Clinical Trial: NCT02799602
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Bayer |
| Information Provided By: | Bayer |
| Last Update Posted: | 2025-12-04 |
Study Overview
Brief Summary
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
Official Title
A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer
Conditions
Metastatic Hormone-sensitive Prostate Cancer
Intervention / Treatment
- Drug: BAY1841788 / darolutamide (ODM-201)
- Drug: Standard ADT (androgen deprivation therapy)
- Drug: Docetaxel
- Drug: Placebo
Other Study ID Numbers
- 17777
- 2015-002590-38
- 2015
Start Date (Actual)
2016-11-30
Primary Completion Date (Actual)
2021-10-25
Study Completion Date (Actual)
2023-04-11
Enrollment (Actual)
1306
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Bayer |
| Information Provided By: | Bayer |
| Last Update Posted: | 2025-12-04 |
Study Overview
Brief Summary
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
Official Title
A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer
Conditions
Metastatic Hormone-sensitive Prostate Cancer
Intervention / Treatment
- Drug: BAY1841788 / darolutamide (ODM-201)
- Drug: Standard ADT (androgen deprivation therapy)
- Drug: Docetaxel
- Drug: Placebo
Other Study ID Numbers
- 17777
- 2015-002590-38
- 2015
Start Date (Actual)
2016-11-30
Primary Completion Date (Actual)
2021-10-25
Study Completion Date (Actual)
2023-04-11
Enrollment (Actual)
1306
Study Type
Interventional
Phase
Phase 3