NCT04038502 · VA Office of Research and Development
Carboplatin or Olaparib for BRcA Deficient Prostate Cancer
(COBRA)
What this study is about
This is an unblinded, randomly assigned clinical study comparing the effectiveness of DNA damaging chemotherapy using carboplatin, to the usual treatment therapy for patients who have metastatic castrate resistant prostate cancer.
View original scientific description
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.
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.
Primary outcome 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.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Signed study informed consent form (ICF) and HIPAA authorization form 2. Male age \> 18 years 3. Diagnosis of prostate cancer (pure small-cell histology or pure high-grade neuroendocrine histology are excluded; neuroendocrine differentiation is allowed) 4. Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy. Patients who have not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapy 5. mCRPC as defined by serum testosterone \< 50 ng/ml (for patients on GnRH analogues or antagonists) and at least one of the following:
- 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, enz
Where
- West Los Angeles, California
- Aurora, Colorado
- Washington D.C., District of Columbia
- Bay Pines, Florida
- Orlando, Florida
- Decatur, Georgia
- Boise, Idaho
- Chicago, Illinois
- Ann Arbor, Michigan
- Minneapolis, Minnesota
- Kansas City, Missouri
- New York, New York
And 6 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2025 · Source of record for eligibility and locations