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NCT04037254 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, sponsored by NRG Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 20
- Study locations
NCT04037254: Completed Phase 1 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, sponsored by NRG Oncology.
NCT04037254 is a Phase 1 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8 that has completed, run by NRG Oncology. The registered enrollment target is 22 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04037254, a Phase 1 study of Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, has completed, sponsored by NRG Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Participants will be considered disease-free if their PSA values remain below 0.1 ng/ml until the completion of treatment. The proportion of patients disease-free at 24 months were to be compared in the two treatment arms using a non-continuity-corrected chi-square test. PSA levels will be assessed prior to the start of RT, at the end of RT, and every three months for 24 months. all PSA values obtained up to and including the two-year landmark must be \< 0.1 ng/ml. Patients who die prior to two
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 |
What the finished NCT04037254 record still lists
NCT04037254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (90% lower).
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.
NCT04037254 names 20 study sites across 7 states, led by California, Georgia, Illinois.
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.
What interventions are being tested in trial NCT04037254?
The interventions under investigation include: Intensity-Modulated Radiation Therapy (RADIATION), Niraparib (DRUG), Gonadotrophin Releasing Hormone (BIOLOGICAL).
Who is sponsoring clinical trial NCT04037254?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04037254's enrollment target sits among peer trials
22 84th of 99 higher than 16 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma 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.
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