A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies
Public ClinicalTrials.gov record NCT05794906. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer
Study identification
- NCT ID
- NCT05794906
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bayer
- Industry
- Enrollment
- 985 participants
Conditions and interventions
Conditions
Interventions
- ADT Other
- Darolutamide (BAY1841788, Nubeqa) Drug
- Placebo matching darolutamide Other
Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2, 2023
- Primary completion
- Jul 29, 2027
- Completion
- Mar 28, 2030
- Last update posted
- Apr 16, 2026
2023 – 2030
United States locations
- U.S. sites
- 25
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital - Phoenix - Cardiology | Phoenix | Arizona | 85054 | — |
| City of Hope - Duarte Cancer Center | Duarte | California | 91010 | — |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Tower Urology | Los Angeles | California | 90048 | — |
| UCLA Clark Urology Center | Los Angeles | California | 90095 | — |
| UCSF Bakar Precision Cancer Medicine Building - Genitourinary | San Francisco | California | 94143 | — |
| Colorado Urology - St. Anthony Hospital Campus | Lakewood | Colorado | 80228 | — |
| Northwestern Medicine - Urology | Chicago | Illinois | 60611 | — |
| The University of Kansas Cancer Center - Richard and Annette Bloch Radiation Oncology Pavilion | Kansas City | Kansas | 66160 | — |
| Chesapeake Urology Associates - Towson | Baltimore | Maryland | 21204 | — |
| Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins | Baltimore | Maryland | 21231 | — |
| Dana-Farber Cancer Institute - Oncology Department | Boston | Massachusetts | 02215 | — |
| Barbara Ann Karmanos Cancer Institute - Detroit Headquarters | Detroit | Michigan | 48201 | — |
| M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center | Minneapolis | Minnesota | 55455 | — |
| Washington University School of Medicine - Center for Advanced Medicine (CAM) | St Louis | Missouri | 63110-1032 | — |
| XCancer Omaha | Omaha | Nebraska | 68130 | — |
| NYU Langone Health | Mineola | New York | 11501 | — |
| Icahn School of Medicine at Mount Sinai - Oncology | New York | New York | 10029 | — |
| Alliance Urology Specialists | Greensboro | North Carolina | 27403 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Carolina Urological Research Center | Myrtle Beach | South Carolina | 29579 | — |
| University Hospital Simmons Cancer Center Genitourinary Clinic | Dallas | Texas | 75235 | — |
| The University of Texas MD Anderson Cancer Center - Texas Medical Center | Houston | Texas | 77030 | — |
| USA Clinical Trials | San Antonio | Texas | 78229 | — |
| The Urology Place | San Antonio | Texas | 78240 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 201 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05794906, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 16, 2026 · Synced Apr 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05794906 live on ClinicalTrials.gov.