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, 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: [email protected]  

Washington DC

• Washington DC VA Medical Center
  Contact: Joao Ascensao, MD by phone: 202-745-8134 or by email: [email protected]      

Florida

• Bay Pines
  Bay Pines VA Healthcare System
  Contact: Behzad Mowlazadeh, MD by phone: 727-398-6661 ext 14559 or by email: [email protected]    
  Contact: Andrew Leone, MD by phone: 727-398-6661 ext 15585 or by email: [email protected]   

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: [email protected]       

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: [email protected]
• New York   
  Manhattan Campus of the VA NY Harbor Healthcare System
  Contact: Daniel Becker, MD by phone: 212-731-6463 or by email: [email protected]    

North Carolina

• Durham
  Durham VA Medical Center
  Contact: Rhonda L Bitting, MD by phone: 919-286-6180 ext 5441 or by email: [email protected]      

Oregon

• Portland
  VA Portland Health Care System
  Contact: Julie Graff, MB by phone: 503-220-8262  or by email: [email protected]     

Pennsylvania

• Philadelphia
  Philadelphia MultiService Center
  Contact: Kyle Robinson, MD by phone: 215-823-5800 ext 2371 or by email: [email protected]    

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: [email protected]     

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

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