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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: Robert.Montgomery@va.gov    
Makayla L DeJong by phone: (206) 277-4527 or by email: Makayla.Dejong@va.gov 

 

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.

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 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
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 
  • have a diagnosis of small cell carcinoma 
  • have leukemia or myelodysplastic syndrome 
  • have heart disease, dementia, other psychiatric disorders