Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Testing the Addition of a New Anti-Cancer Drug, Niraparib, to the Usual Treatment (Hormone and Radiation Therapy) for Prostate Cancer With a High Chance of Recurring
NCT04037254 · View on ClinicalTrials.gov ↗
Study Summary
This is a phase I-II trial to find the safety and activity of adding a new drug (neraparib) to the usual treatment (radiation combined with male hormone deprivation therapy) in lowering the chance of prostate cancer growing or returning. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding niraparib to the usual care may lower the chance of prostate cancer growing or returning.
Conditions Studied
Interventions
- RADIATION Intensity-Modulated Radiation Therapy
- DRUG Niraparib
- BIOLOGICAL Gonadotrophin Releasing Hormone
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center — Duarte
- Cedars Sinai Medical Center — Los Angeles
- Fremont - Rideout Cancer Center — Marysville
- University of California Davis Comprehensive Cancer Center — Sacramento
- City of Hope Upland — Upland
Georgia
- Grady Health System — Atlanta
- Emory University Hospital/Winship Cancer Institute — Atlanta
- Emory Saint Joseph's Hospital — Atlanta
- CTCA at Southeastern Regional Medical Center — Newnan
Illinois
- Alton Memorial Hospital — Alton
- Northwestern University — Chicago
- Rush University Medical Center — Chicago
- Carle Cancer Center — Urbana
Arizona
- Banner MD Anderson Cancer Center — Gilbert
- University of Arizona Cancer Center-Orange Grove Campus — Tucson
- University of Arizona Cancer Center-North Campus — Tucson
Delaware
- Helen F Graham Cancer Center — Newark
- Medical Oncology Hematology Consultants PA — Newark
District of Columbia
- George Washington University Medical Center — Washington D.C.
Iowa
- University of Iowa/Holden Comprehensive Cancer Center — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2025-12-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04037254
The ClinicalTrials.gov registry entry for NCT04037254 describes a study currently listed as completed. It is categorized as Phase 1, 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 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 162 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions — of which Intensity-Modulated Radiation Therapy 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: NCT04037254 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Georgia, Illinois. 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 NCT04037254 about?
NCT04037254 is a clinical study titled "Testing the Addition of a New Anti-Cancer Drug, Niraparib, to the Usual Treatment (Hormone and Radiation Therapy) for Prostate Cancer With a High Chance of Recurring". This is a phase I-II trial to find the safety and activity of adding a new drug (neraparib) to the usual treatment (radiation combined with male hormone deprivation therapy) in lowering the chance of prostate cancer growing or returning. Niraparib is an inhibitor of PARP, an enzyme that helps repair...
What is the current status of trial NCT04037254?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2019-10-08. Estimated completion is 2025-12-23.
What conditions does trial NCT04037254 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04037254?
The interventions under investigation include: Intensity-Modulated Radiation Therapy (RADIATION), Niraparib (DRUG), Gonadotrophin Releasing Hormone (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04037254?
This trial is sponsored by NRG Oncology, which has 162 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04037254 being conducted?
This trial has 20 study locations across Arizona, California, Delaware, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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