A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.
Open-label Study of Androgen Receptor Inhibition With dArolutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Men With Metastatic Hormone-Sensitive Prostate Cancer Using an External Control Arm
Sponsor: Bayer
This PHASE2 trial investigates Metastatic Hormone-sensitive Prostate Cancer and is currently ongoing. Bayer leads this study, which shows 42 recorded versions since 2021 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Change History
42 versions recorded-
Feb 2026 — Present [monthly]
Active Not Recruiting PHASE2
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Jan 2026 — Feb 2026 [monthly]
Active Not Recruiting PHASE2
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Dec 2025 — Jan 2026 [monthly]
Active Not Recruiting PHASE2
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Nov 2025 — Dec 2025 [monthly]
Active Not Recruiting PHASE2
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Oct 2025 — Nov 2025 [monthly]
Active Not Recruiting PHASE2
▶ Show 37 earlier versions
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Sep 2025 — Oct 2025 [monthly]
Active Not Recruiting PHASE2
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Aug 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE2
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Jun 2025 — Aug 2025 [monthly]
Active Not Recruiting PHASE2
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May 2025 — Jun 2025 [monthly]
Active Not Recruiting PHASE2
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Apr 2025 — May 2025 [monthly]
Active Not Recruiting PHASE2
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Mar 2025 — Apr 2025 [monthly]
Active Not Recruiting PHASE2
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Feb 2025 — Mar 2025 [monthly]
Active Not Recruiting PHASE2
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Jan 2025 — Feb 2025 [monthly]
Active Not Recruiting PHASE2
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Dec 2024 — Jan 2025 [monthly]
Active Not Recruiting PHASE2
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Nov 2024 — Dec 2024 [monthly]
Active Not Recruiting PHASE2
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Oct 2024 — Nov 2024 [monthly]
Active Not Recruiting PHASE2
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Sep 2024 — Oct 2024 [monthly]
Active Not Recruiting PHASE2
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Aug 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2
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Jul 2024 — Aug 2024 [monthly]
Active Not Recruiting PHASE2
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May 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE2
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Apr 2024 — May 2024 [monthly]
Active Not Recruiting PHASE2
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Feb 2024 — Apr 2024 [monthly]
Active Not Recruiting PHASE2
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Jan 2024 — Feb 2024 [monthly]
Active Not Recruiting PHASE2
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Nov 2023 — Jan 2024 [monthly]
Active Not Recruiting PHASE2
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Oct 2023 — Nov 2023 [monthly]
Active Not Recruiting PHASE2
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Sep 2023 — Oct 2023 [monthly]
Active Not Recruiting PHASE2
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Aug 2023 — Sep 2023 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Jul 2023 — Aug 2023 [monthly]
Recruiting PHASE2
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Jun 2023 — Jul 2023 [monthly]
Recruiting PHASE2
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May 2023 — Jun 2023 [monthly]
Recruiting PHASE2
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Apr 2023 — May 2023 [monthly]
Recruiting PHASE2
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Mar 2023 — Apr 2023 [monthly]
Recruiting PHASE2
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Feb 2023 — Mar 2023 [monthly]
Recruiting PHASE2
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Jan 2023 — Feb 2023 [monthly]
Recruiting PHASE2
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Dec 2022 — Jan 2023 [monthly]
Recruiting PHASE2
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Nov 2022 — Dec 2022 [monthly]
Recruiting PHASE2
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Sep 2022 — Nov 2022 [monthly]
Recruiting PHASE2
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Jul 2022 — Sep 2022 [monthly]
Recruiting PHASE2
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Mar 2022 — Jul 2022 [monthly]
Recruiting PHASE2
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Feb 2022 — Mar 2022 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Nov 2021 — Feb 2022 [monthly]
Not Yet Recruiting PHASE2
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Oct 2021 — Nov 2021 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Bayer
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Albuquerque, United States, Ann Arbor, United States, Atlanta, United States, Bala-Cynwyd, United States, Baltimore, United States, Chicago, United States, Cincinnati, United States, Clifton, United States, Detroit, United States, Fairfax, United States and 17 more location s