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NCT04038502 · ClinicalTrials.gov registry record · Phase 2
Carboplatin or Olaparib for BRcA Deficient Prostate Cancer
A Phase 2 study of Metastatic Castrate Resistant Prostate Cancer and Bard1, Brca1, Brca2, Brip1, Chek1, Fancl, Palb2, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 18
- Study locations
NCT04038502 is a Phase 2 study of Metastatic Castrate Resistant Prostate Cancer and Bard1, Brca1, Brca2, Brip1, Chek1, Fancl, Palb2 that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 100 participants. The trial reports 18 study locations across 16 states.
The verdict
NCT04038502, a Phase 2 study of Metastatic Castrate Resistant Prostate Cancer and Bard1, Brca1, Brca2, Brip1, Chek1, Fancl, Palb2, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 18
- Study locations
Study Summary
This is an unblinded, randomized clinical study comparing the efficacy of DNA damaging chemotherapy using carboplatin, to standard of care therapy for patients who have metastatic castrate resistant prostate cancer. This trial will use olaparib or carboplatin as initial therapy with crossover to the alternate or second-line drug after first progression for patients with tumors containing BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L inactivating mutations. Participants are randomized (1:1) and receive either carboplatin (AUC 5, IV) every 21 days, first or olaparib taken orally (300 mg), twice daily in 28 day cycles, until intolerance, complete response, or progression by Prostate Cancer Working Group 3 (PCWG3) criteria. Participants then crossover from the first-line therapy to the second-line therapy with the opposite study medication and receive treatment to intolerance or progression (whichever is first). Enrolled participants will be allowed to crossover to second line therapy if they continue to meet initial eligibility criteria, and at least three weeks have elapsed since last administration of either carboplatin or olaparib. Throughout the study, safety and tolerability will be assessed. Progression will be evaluated with bone scan, CT of the abdomen/pelvis, or MRI and PSA as per PCWG3 criteria.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Olaparib
Study Locations (18)
Florida
- Bay Pines VA Healthcare System, Pay Pines, FL - Bay Pines
- Orlando VA Medical Center, Orlando, FL - Orlando
New York
- Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY - New York
- James J. Peters VA Medical Center, Bronx, NY - The Bronx
California
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA - West Los Angeles
Colorado
- Rocky Mountain Regional VA Medical Center, Aurora, CO - Aurora
District of Columbia
- Washington DC VA Medical Center, Washington, DC - Washington D.C.
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
Idaho
- Boise VA Medical Center, Boise, ID - Boise
Illinois
- Jesse Brown VA Medical Center, Chicago, IL - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04038502
The ClinicalTrials.gov registry entry for NCT04038502 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Metastatic Castrate Resistant Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Carboplatin is the first listed.
NCT04038502 reports 18 study locations spanning 16 distinct geographic areas - top geographies include Florida, New York, California.
Frequently Asked Questions
What is clinical trial NCT04038502 about?
NCT04038502 is a clinical study titled "Carboplatin or Olaparib for BRcA Deficient Prostate Cancer". This is an unblinded, randomized clinical study comparing the efficacy of DNA damaging chemotherapy using carboplatin, to standard of care therapy for patients who have metastatic castrate resistant prostate cancer. This trial will use olaparib or carboplatin as initial therapy with crossover to the...
What is the current status of trial NCT04038502?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2019-10-01. Estimated completion is 2027-08-31.
What conditions does trial NCT04038502 study?
This clinical trial studies the following conditions: Metastatic Castrate Resistant Prostate Cancer, Bard1, Brca1, Brca2, Brip1, Chek1, Fancl, Palb2, RAD51B, RAD51C, RAD51D, or RAD54L Mutations.
What interventions are being tested in trial NCT04038502?
The interventions under investigation include: Carboplatin (DRUG), Olaparib (DRUG).
Who is sponsoring clinical trial NCT04038502?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04038502 being conducted?
This trial has 18 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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