Your session is about to expire
← Back to Search
Alkylating agents
Carboplatin vs Olaparib for Prostate Cancer (COBRA Trial)
Phase 2
Recruiting
Led By Maneesh Jain, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
mCRPC as defined by serum testosterone < 50 ng/ml (for patients on GnRH analogues or antagonists) and at least one of the following:
Progression of metastatic bone disease on bone scan, CT or MRI with > 2 new lesions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through duration of the study, up to six years
Awards & highlights
COBRA Trial Summary
This trial is comparing the efficacy of two treatments for patients with metastatic castrate resistant prostate cancer who have tumors containing BRCA1, BRCA2 or PALB2 inactivating DNA mutations.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has specific gene mutations (like BRCA1/2). They must have ongoing hormone treatment, measurable disease progression, normal organ/bone marrow function, no brain metastasis or other cancers being treated, and not taken certain drugs before.Check my eligibility
What is being tested?
The trial compares carboplatin chemotherapy to olaparib pills for men with a type of advanced prostate cancer. Patients are randomly chosen to start with one drug and can switch to the other if the first one stops working. The study checks how well each drug controls the cancer.See study design
What are the potential side effects?
Olaparib may cause nausea, fatigue, anemia, blood clots while carboplatin can lead to nerve damage, kidney problems, allergic reactions. Side effects vary by individual and should be closely monitored throughout the trial.
COBRA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is resistant to medical or surgical treatments to lower testosterone.
Select...
My scans show my bone cancer has worsened with more than 2 new spots.
Select...
I have been treated with medications like abiraterone, enzalutamide, apalutamide, or darolutamide.
Select...
I am mostly self-sufficient and can carry out daily activities.
Select...
My cancer has specific mutations (RAD51B/C/D or RAD54L) confirmed by a certified test.
Select...
I am on hormone therapy for cancer or have had surgery to remove my testicles.
Select...
I am a man older than 18.
Select...
I have been diagnosed with prostate cancer, but it's not the small-cell or high-grade neuroendocrine type.
Select...
My kidneys work well enough, based on a specific calculation.
COBRA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through duration of the study, up to six years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through duration of the study, up to six years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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.
Secondary outcome measures
Grade 3 and 4 toxicities in first and second-line setting
PSA measurements/response
time interval between randomization and second documented disease progression during or after second-line or death (due to any cause)
Other outcome measures
Exploratory Objective - PFS
Exploratory Objective - objective response rate
Exploratory Objective- objective duration of response
COBRA Trial Design
2Treatment groups
Active Control
Group I: Treatment Arm 2 - Olaparib to CarboplatinActive Control2 Interventions
Participants are prescribed olaparib which is taken orally at home, twice daily, 300 mg in 28 day cycles, as first line therapy. For second line (crossover), carboplatin is administered AUC 5 IV every 21 days thereafter.
Group II: Treatment Arm 1 - Carboplatin to OlaparibActive Control2 Interventions
Participants are administered carboplatin AUC 5 IV first, which is administered Cycle-1, Day-1, and then every 21 days as first line therapy. For second line (crossover), olaparib is prescribed and taken orally at home, twice daily, 300 mg in 28 day cycles.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,184 Total Patients Enrolled
15 Trials studying Prostate Cancer
8,785 Patients Enrolled for Prostate Cancer
Maneesh Jain, MDPrincipal InvestigatorWashington DC VA Medical Center, Washington, DC
Robert B. Montgomery, MDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
3 Previous Clinical Trials
93 Total Patients Enrolled
1 Trials studying Prostate Cancer
14 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing treatment for another cancer.My prostate cancer is resistant to medical or surgical treatments to lower testosterone.My cancer diagnosis was confirmed through tissue examination.My scans show my bone cancer has worsened with more than 2 new spots.I have been treated with medications like abiraterone, enzalutamide, apalutamide, or darolutamide.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I have been treated with platinum, mitoxantrone, or PARP inhibitors for prostate cancer.I do not have active hepatitis or severe liver disease.I have had a heart attack or serious heart disease in the last 6 months.I am not taking strong or moderate CYP3A inhibitors, or I can stop them for 2 weeks before starting olaparib.I am not currently using, or have stopped using strong or moderate drugs that affect liver enzymes as required before starting olaparib.I am mostly self-sufficient and can carry out daily activities.My cancer has specific mutations (RAD51B/C/D or RAD54L) confirmed by a certified test.I am on hormone therapy for cancer or have had surgery to remove my testicles.I cannot swallow pills or have stomach issues affecting medication absorption.My organ and bone marrow functions are normal as tested within the last 28 days.I am a man older than 18.I have been diagnosed with prostate cancer, but it's not the small-cell or high-grade neuroendocrine type.My kidneys work well enough, based on a specific calculation.I have brain metastases.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm 2 - Olaparib to Carboplatin
- Group 2: Treatment Arm 1 - Carboplatin to Olaparib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can patients access this trial at present?
"Per clinicaltrials.gov, this investigation is in the process of seeking volunteers for participation. It was launched on October 1st 2019 and its last modification took place on November 23rd 2022."
Answered by AI
What maladies is Treatment Arm 2 - Olaparib to Carboplatin usually prescribed for?
"Treatment Arm 2 - Olaparib to Carboplatin is often prescribed for cancer patients who have already received chemotherapy. This combination of drugs has also been found effective for advanced thymoma, testicular cancer and carcinoma, neuroendocrine."
Answered by AI
What adverse effects have been reported for patients taking the combination of olaparib and carboplatin?
"Though data supporting efficacy is presently lacking, Treatment Arm 2 - Olaparib to Carboplatin has been deemed a safe option with an estimated score of 2 on the scale."
Answered by AI
How many participants have enrolled in this clinical experiment?
"Affirmative. The information hosted on clinicaltrials.gov states that this medical exploration, which was originally uploaded to the platform on October 1st 2019, is currently searching for volunteer trialists. A total of 100 individuals need to be enrolled from 14 different centres."
Answered by AI
Could you provide me with a list of experiments that have examined the efficacy of Olaparib to Carboplatin in relation to Treatment Arm 2?
"Treatment Arm 2 - Olaparib to Carboplatin was first administered in 2002 at H Central de Asturias. To date, 894 clinical trials related to this arm have been completed; meanwhile, there are currently 865 active studies being conducted out of Kansas City, Missouri."
Answered by AI
Are there numerous medical centers in the US that are running this clinical experiment?
"Currently, 14 different medical centers are taking part in this trial. Examples include the Kansas City VA Medical Center located in Missouri and Orlando VA Medical Centre based in Florida; along with Bay Pines VA Healthcare System situated in Pay Pines, FL."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger