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Carboplatin or Olaparib for BRcA Deficient Prostate Cancer

NCT04038502 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-20

No results posted yet for this 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

  • Metastatic Castrate Resistant Prostate Cancer
  • BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2
  • RAD51B, RAD51C, RAD51D, or RAD54L Mutations

Interventions

DRUG

Carboplatin

Chemotherapy FDA approved drug used to treat: ovarian, lung, head and neck cancers. It is sometimes used in combination with other medications or off-label use to treat other metastatic cancers.

DRUG

Olaparib

Olaparib is a targeted therapy drug that is used for mCRPC and is approved by the FDA for this use.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Robert B. Montgomery, MD · VA Puget Sound Health Care System Seattle Division, Seattle, WA

  • Ryan Burri, MD · Bay Pines VA Healthcare System, Pay Pines, FL

  • Phoebe Tsao, MD MSc · VA Ann Arbor Healthcare System, Ann Arbor, MI

  • Maneesh Jain, MD · Washington DC VA Medical Center, Washington, DC

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04038502 on ClinicalTrials.gov