Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
Phase 3
Completed
NCT04736199
| Condition | Prostatic Neoplasms |
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| Phase | Phase 3 |
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| Sponsor | Bayer |
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| Status | Completed |
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| Enrollment | 669 participants |
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| Interventions | Darolutamide (Nubeqa, BAY1841788), Androgen deprivation therapy (ADT) |
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| Start date | Feb 23, 2021 |
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| Completion date | Jun 7, 2024 |
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| Results posted | Aug 8, 2025 |
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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.
Radiological Progression-free Survival (rPFS) Assessed by Central Review
From randomization to the date when 222 rPFS events were observed, approximately 36 months · Months
| Darolutamide+ADT | NA Months |
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| Placebo+ADT | 25.0 Months |
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| p-value | <0.0001 |
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| Hazard Ratio (HR) | 0.541 (95% CI 0.413–0.707) |
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Open in BENITIONS
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