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Olaparib or Carboplatin for Prostate Cancer with DNA Repair Mutations

This study is for men with metastatic castrate resistant prostate cancer (mCRPC), meaning the cancer has spread and no longer responds to hormone therapy. You may be eligible if your tumor has specific changes (mutations) in genes like BRCA1 or BRCA2, which are involved in repairing DNA. The study compares two treatments: olaparib, a targeted therapy already approved for mCRPC, and carboplatin, a chemotherapy drug. Participants will be randomly assigned to receive either olaparib or carboplatin as their initial treatment. If your cancer progresses, you may switch to the other treatment. The main goal is to see how long patients live without their cancer getting worse (progression-free survival). The study is currently recruiting up to 100 participants.

Study design
This is an unblinded, randomized study comparing two treatments for metastatic castrate resistant prostate cancer. Approximately 100 participants will be randomly assigned to one of two treatment groups.
What's involved
You will receive either carboplatin intravenously every 21 days or olaparib orally twice daily in 28-day cycles. Treatment continues until intolerance, complete response, or cancer progression.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured throughout the study, for up to six years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04038502

Carboplatin or Olaparib for BRcA Deficient Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalHealth services
VA Office of Research and Development
~100 participants
Updated 2025-08-20 on ClinicalTrials.gov
What's tested:CarboplatinOlaparib

At a glance

Recruiting sites
15 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS-1L) defined as the time interval between randomization and first documented disease progression or death due to any cause reported during, or after, first-line treatment.
Measured over Through duration of the study, up to six years

Conditions

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

Explore related trials

Prostate CarcinomaBARD1 GeneBRCA1 GeneBRCA2 GeneBRIP1 GeneDNA Repair and Recombination Protein RAD54-LikeE3 Ubiquitin-Protein Ligase FANCLPartner and Localizer of BRCA2RAD51B GeneRAD51C GeneRAD51D GeneSerine/Threonine-Protein Kinase Chk1

Where it's being run

18 sites across 16 states
Florida2
New York2
California1
Colorado1
District of Columbia1
Georgia1
Idaho1
Illinois1

Study leadership

  • Robert B. Montgomery, MD · PRINCIPAL_INVESTIGATOR · VA Puget Sound Health Care System Seattle Division, Seattle, WA
  • Ryan Burri, MD · PRINCIPAL_INVESTIGATOR · Bay Pines VA Healthcare System, Pay Pines, FL
  • Phoebe Tsao, MD MSc · PRINCIPAL_INVESTIGATOR · VA Ann Arbor Healthcare System, Ann Arbor, MI
  • Maneesh Jain, MD · PRINCIPAL_INVESTIGATOR · Washington DC VA Medical Center, Washington, DC

Who to contact

Robert B Montgomery, MD
[email protected]
(206) 277-6878
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart
Evaluable disease progression by modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)
Progression of metastatic bone disease on bone scan, CT or MRI with \> 2 new lesions 6. Prior therapy with abiraterone acetate, enzalutamide, apalutamide, or darolutamide 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of \< 2 (see Appendix 3, ECOG Grading Scale) 8. Results of previous standard DNA testing, or previous research testing, which confirms RAD51B, RAD51C, RAD51D, or RAD54L mutations (see Introduction, Section 2 for study design and previous research on targeted therapy) from primary, metastatic tumor or circulating tumor DNA, or pathogenic/likely pathogenic germline variant as assessed by a CLIA certified laboratory level assay for DNA sequencing. 9. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
Hemoglobin \> 10.0 g/dL
Absolute neutrophil count (ANC) \> 1.5 x 109/L
Platelet count \> 100 x 109/L
Total bilirubin \< 1.5 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) \< 2.5 x institutional upper limit of normal unless liver metastases are present in which case, they must be \< 5x ULN
Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of \>51 mL/min: Estimated creatinine clearance =(140-age \[years\]) x weight (kg))/ (serum creatinine (mg/dL) x 72)

What this trial measures

  • Progression-free survival (PFS-1L) defined as the time interval between randomization and first documented disease progression or death due to any cause reported during, or after, first-line treatment.Through duration of the study, up to six years

    Progression free survival (PFS) by bone scan or measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST 1.1) to initial therapy (PFS-1L) with either study drug.