Treating Metastatic Prostate Cancer with Chemotherapy or PARP Inhibitor in People with Mutations (COBRA)
https://www.facingourrisk.org/research-clinical-trials/study/210/treating-metastatic-prostate-cancer-with-chemotherapy-or-parp-inhibitor-in-people-with-mutations-cobra
Clinicaltrials.gov identifier:
NCT04038502 (https://clinicaltrials.gov/show/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: Robert.Montgomery@va.gov
Makayla L DeJong by phone: (206) 277-4527 or by email: Makayla.Dejong@va.gov
About the Study
This study is comparing carboplatin chemotherapy to the drug, olaparib (a type of targeted therapy) as first-line treatment for metastatic castration-resistant prostate cancer in people with a BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D or RAD54L inherited mutation found through genetic testing, or tumor mutation found through biomarker 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 targeted therapy 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 Olaparib 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 olaparib. Throughout the study, safety and the ability of participants to tolerate the treatment will be measured.
Study Sites
California
- West Los Angeles
VA Greater Los Angeles Healthcare System
Contact: Matthew Rettig, MD by phone: 310-478-3711 ext 4761 or by email: matthew.rettig@va.gov
Washington DC
- Washington DC VA Medical Center
Contact: Joao Ascensao, MD by phone: 202-745-8134 or by email: Joao.Ascensao@va.gov
Florida
- Bay Pines
Bay Pines VA Healthcare System
Contact: Behzad Mowlazadeh, MD by phone: 727-398-6661 ext 14559 or by email: Behzad.Mowlazadeh@va.gov
Contact: Andrew Leone, MD by phone: 727-398-6661 ext 15585 or by email: Andrew.Leone@va.gov
Illinois
- Chicago
Jesse Brown VA Medical Center
Contact: Joshua Meeks, MD by phone: 312-363-8959
Michigan
- Ann Arbor, Michigan
VA Ann Arbor Healthcare System
Contact: Ramnath Nithya, MD by phone: 734-845-5800 or by email: Nithya.Ramnath@va.gov
New York
- Bronx, New York
James J. Peters VA Medical Center
Contact: Antonio Fojo, MD by phone: 718-584-9000 ext 669 or by email: antonio.fojo@va.gov - New York
Manhattan Campus of the VA NY Harbor Healthcare System
Contact: Daniel Becker, MD by phone: 212-731-6463 or by email: daniel.becker2@va.gov
North Carolina
- Durham
Durham VA Medical Center
Contact: Rhonda L Bitting, MD by phone: 919-286-6180 ext 5441 or by email: rhonda.bitting@va.gov
Oregon
- Portland
VA Portland Health Care System
Contact: Julie Graff, MB by phone: 503-220-8262 or by email: julie.graff@va.gov
Pennsylvania
- Philadelphia
Philadelphia MultiService Center
Contact: Kyle Robinson, MD by phone: 215-823-5800 ext 2371 or by email: kyle.robinson3@va.gov
Washington
- Seattle
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Contact: Robert B Montgomery, MD by phone: 206-277-6878 or by email: Robert.Montgomery@va.gov
This Study is Open To:
Men 18 years or older with the following may be able to participate:
- have a diagnosis of metastatic castration resistant prostate cancer
- are on androgen-deprivation therapy or have had an orchiectomy
- have had previous testing which confirms inherited or tumor BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D or RAD54L mutation
- have received prior treatment with abiraterone acetate, enzalutamide, apalutamide or darolutamide
This Study is Not Open To:
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 PARP inhibitor
- have a diagnosis of small cell carcinoma
- have leukemia or myelodysplastic syndrome
- have heart disease, dementia, other psychiatric disorders
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.