Treating Metastatic Prostate Cancer with Chemotherapy or PARP Inhibitor in People with Mutations (COBRA)
Clinicaltrials.gov identifier:
NCT04038502
Treatment
Treatment study for mCRPC with an inherited or tumor mutation in BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D or RAD54L
Study Contact Information:
For additional information, please contact:
Robert B Montgomery, MD by phone: 206-277-6878 or by email: [email protected]
Makayla L DeJong by phone: (206) 277-4527 or by email: [email protected]
Treating Metastatic Prostate Cancer with Chemotherapy or PARP Inhibitor in People with Mutations (COBRA)
About the Study
This study is comparing carboplatin chemotherapy to the drug, (a type of ) as treatment for castration-resistant cancer in people with a , , , , CHEK1, FANCL, , RAD51B, , or RAD54L found through genetic testing, or tumor mutation found through testing.
What the Study Involves
Participants will be assigned to one of two different groups, and both the participant and their doctors will know which treatment they are receiving.
- Group 1 will receive intravenous chemotherapy (carboplatin) every 21 days, until they can no longer tolerate the treatment, their tumor has a complete response to the treatment, or their tumor grows and their cancer gets worse on the treatment. At this point in the study participants will be allowed to "crossover" to the other group (Group 2) and will receive the olaparib twice daily by mouth until they can no longer tolerate the treatment, or their disease gets worse, whichever is first.
- Group 2 will receive taken twice daily by mouth, until they can no longer tolerate the treatment, their tumor has a complete response to the treatment, or their tumor grows or their cancer gets worse on the treatment. At this point, they will be allowed to "crossover" to Group 1 and receive intravenous carboplatin every 21 days, until they can no longer tolerate the treatment, or their disease progresses, whichever is first.
Participants can crossover to the other therapy as long as they still meet inclusion criteria and it has been 3 weeks since their last treatment of either carboplatin or . Throughout the study, safety and the ability of participants to tolerate the treatment will be measured.
California
City: West Los Angeles RECRUITING
Facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Contact Info:
[email protected]
310-478-3711
Colorado
City: Aurora RECRUITING
Facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
Contact Info:
[email protected]
District of Columbia
City: Washington RECRUITING
Facility: Washington DC VA Medical Center, Washington, DC
Contact Info:
[email protected]
202-745-8134
Florida
City: Bay Pines RECRUITING
Facility: Bay Pines VA Healthcare System, Pay Pines, FL
Contact Info:
[email protected]
727-398-6661
[email protected]
7273986661
City: Orlando RECRUITING
Facility: Orlando VA Medical Center, Orlando, FL
Contact Info:
[email protected]
Georgia
City: Decatur RECRUITING
Facility: Atlanta VA Medical and Rehab Center, Decatur, GA
Contact Info:
404-321-6111
Idaho
City: Boise RECRUITING
Facility: Boise VA Medical Center, Boise, ID
Contact Info:
[email protected]
Illinois
City: Chicago RECRUITING
Facility: Jesse Brown VA Medical Center, Chicago, IL
Contact Info:
312-363-8959
Michigan
City: Ann Arbor RECRUITING
Facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
Contact Info:
[email protected]
734-845-5800
Minnesota
City: Minneapolis RECRUITING
Facility: Minneapolis VA Health Care System, Minneapolis, MN
Contact Info:
[email protected]
Missouri
City: Kansas City RECRUITING
Facility: Kansas City VA Medical Center, Kansas City, MO
Contact Info:
206-277-6878
North Carolina
City: Durham RECRUITING
Facility: Durham VA Medical Center, Durham, NC
Contact Info:
[email protected]
919-286-6180
New York
City: Bronx RECRUITING
Facility: James J. Peters VA Medical Center, Bronx, NY
Contact Info:
[email protected]
718-584-9000
City: New York RECRUITING
Facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Contact Info:
[email protected]
212-731-6463
Oregon
City: Portland RECRUITING
Facility: VA Portland Health Care System, Portland, OR
Contact Info:
[email protected]
503-220-8262
Pennsylvania
City: Philadelphia RECRUITING
Facility: Philadelphia MultiService Center, Philadelphia, PA
Contact Info:
[email protected]
215-823-5800
Washington
City: Seattle RECRUITING
Facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
Contact Info:
[email protected]
206-277-6878
Robert B. Montgomery, MD
Wisconsin
City: Madison RECRUITING
Facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
Contact Info:
[email protected]
Men 18 years or older with the following may be able to participate:
- have a diagnosis of castration resistant cancer
- are on androgen-deprivation therapy or have had an orchiectomy
- have had previous testing which confirms inherited or tumor , , , , CHEK1, FANCL, , RAD51B, , or RAD54L mutation
- have received prior treatment with acetate, , apalutamide or darolutamide
Men with the following may not participate:
- are participating in another clinical trial or being treated for other cancers
- have been treated for mCRPC with platinum, mitoxantrone, or a
- have a diagnosis of small cell carcinoma
- have leukemia or myelodysplastic syndrome
- have heart disease, dementia, other psychiatric disorders