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NCT05794906 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Biochemically Recurrent Prostate Cancer, sponsored by Bayer.
- Active
- Registry status
- Phase 3
- Development phase
- 985
- Enrollment target
- 20
- Study locations
NCT05794906: Active Phase 3 study of Biochemically Recurrent Prostate Cancer, sponsored by Bayer.
NCT05794906 is a Phase 3 study of Biochemically Recurrent Prostate Cancer that is active but no longer recruiting, run by Bayer. The registered enrollment target is 985 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05794906, a Phase 3 study of Biochemically Recurrent Prostate Cancer, is active but no longer recruiting, sponsored by Bayer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 985 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen \[PSMA\] positron emission tomography \[PET\]) /computed tomography \[CT\]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death du
Conditions Studied
Interventions
- DRUG Darolutamide (BAY1841788, Nubeqa)
- OTHER Placebo matching darolutamide
- OTHER ADT
Study Locations (20)
California
- City of Hope - Duarte Cancer Center - Duarte
- USC Norris Comprehensive Cancer Center - Los Angeles
- Tower Urology - Los Angeles
- UCLA Clark Urology Center - Los Angeles
- UCSF Bakar Precision Cancer Medicine Building - Genitourinary - San Francisco
Maryland
- Chesapeake Urology Associates - Towson - Baltimore
- Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins - Baltimore
New York
- NYU Langone Health - Mineola
- Icahn School of Medicine at Mount Sinai - Oncology - New York
Arizona
- Mayo Clinic Hospital - Phoenix - Cardiology - Phoenix
Colorado
- Colorado Urology - St. Anthony Hospital Campus - Lakewood
Illinois
- Northwestern Medicine - Urology - Chicago
Kansas
- The University of Kansas Cancer Center - Richard and Annette Bloch Radiation Oncology Pavilion - Kansas City
Massachusetts
- Dana-Farber Cancer Institute - Oncology Department - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 985 participants |
| Start Date | 2023-04-03 |
| Est. Completion | 2030-03-29 |
| Phase | Phase 3 |
What the registry record for NCT05794906 still lists
NCT05794906 is an interventional study that assigns participants to a tested intervention. The registered 985 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% higher).
The record links to 1 condition, with Biochemically Recurrent Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Darolutamide (BAY1841788, Nubeqa) is the first listed.
NCT05794906 names 20 study sites across 14 states, led by California, Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT05794906 about?
NCT05794906 is a clinical study titled "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". Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker ...
What is the current status of trial NCT05794906?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 985 participants. The study started on 2023-04-03. Estimated completion is 2030-03-29.
What conditions does trial NCT05794906 study?
This clinical trial studies the following conditions: Biochemically Recurrent Prostate Cancer.
What interventions are being tested in trial NCT05794906?
The interventions under investigation include: Darolutamide (BAY1841788, Nubeqa) (DRUG), Placebo matching darolutamide (OTHER), ADT (OTHER).
Who is sponsoring clinical trial NCT05794906?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05794906 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05794906's enrollment target sits among peer trials
985 320th of 2000 higher than 1,680 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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