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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
NCT05794906 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05794906
The ClinicalTrials.gov registry entry for NCT05794906 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 985 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05794906 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Maryland, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05794906?
The interventions under investigation include: Darolutamide (BAY1841788, Nubeqa) (DRUG), Placebo matching darolutamide (OTHER), ADT (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05794906?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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