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A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described
NCT04122976 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice.
Conditions Studied
Interventions
- DRUG Darolutamide(Nubeqa, BAY1841788)
Study Locations (20)
New York
- Beacon Cancer Care — Beacon
- Integrated Medical Professionals, PLLC — North New Hyde Park
- Premier Medical Group of the Hudson Valley, PC — Poughkeepsie
- Associated Medical Professional Urology — Syracuse
Florida
- Manatee Medical Research Institute — Bradenton
- Advanced Urology Institute — Daytona Beach
North Carolina
- Dukes Cancer Intitute Center for Prostate and Urologic Cancers — Durham
- Associated Urologists of NC — Raleigh
Alabama
- Urology Centers of Alabama — Homewood
Arizona
- Arizona Institute of Urology — Tucson
California
- Genesis Comprehensive Prostate Cancer Center — San Diego
Colorado
- The Urology Center of Colorado — Denver
Illinois
- Research by Design, LLC — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 805 participants |
| Start Date | 2020-01-30 |
| Est. Completion | 2026-10-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04122976
The ClinicalTrials.gov registry entry for NCT04122976 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, 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 805 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 Prostate Cancer appearing as the primary indexed condition, and to 1 intervention — of which Darolutamide(Nubeqa, BAY1841788) 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: NCT04122976 reports 20 study locations spanning 15 distinct geographic areas — top geographies include New York, Florida, North Carolina. 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 NCT04122976 about?
NCT04122976 is a clinical study titled "A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described". The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to tre...
What is the current status of trial NCT04122976?
This trial is currently active not recruiting. The enrollment target is 805 participants. The study started on 2020-01-30. Estimated completion is 2026-10-07.
What conditions does trial NCT04122976 study?
This clinical trial studies the following conditions: 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 NCT04122976?
The interventions under investigation include: Darolutamide(Nubeqa, BAY1841788) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04122976?
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 NCT04122976 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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