Carboplatin or Olaparib for BRcA Deficient Prostate Cancer
Public ClinicalTrials.gov record NCT04038502. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Multicenter Phase II Study to Compare the Efficacy of Carboplatin as First-line Followed by Second-line Olaparib Versus Olaparib as First-line Followed by Second-line Carboplatin in the Treatment of Patients With Castration Resistant Prostate Cancer Containing Homologous Recombination Deficiency
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04038502
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2019
- Primary completion
- Aug 30, 2027
- Completion
- Aug 30, 2027
- Last update posted
- Aug 19, 2025
2019 – 2027
United States locations
- U.S. sites
- 18
- U.S. states
- 16
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073 | Recruiting |
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045 | Recruiting |
| Washington DC VA Medical Center, Washington, DC | Washington D.C. | District of Columbia | 20422-0001 | Recruiting |
| Bay Pines VA Healthcare System, Pay Pines, FL | Bay Pines | Florida | 33744-0000 | Terminated |
| Orlando VA Medical Center, Orlando, FL | Orlando | Florida | 32827 | Recruiting |
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033 | Recruiting |
| Boise VA Medical Center, Boise, ID | Boise | Idaho | 83702 | Recruiting |
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | 60612 | Terminated |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | Recruiting |
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417-2309 | Recruiting |
| Kansas City VA Medical Center, Kansas City, MO | Kansas City | Missouri | 64128 | Recruiting |
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York | 10010 | Recruiting |
| James J. Peters VA Medical Center, Bronx, NY | The Bronx | New York | 10468-3904 | Terminated |
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | Recruiting |
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | Recruiting |
| Philadelphia MultiService Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19106 | Recruiting |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108-1532 | Recruiting |
| William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin | 53705-2254 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04038502, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 19, 2025 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04038502 live on ClinicalTrials.gov.