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Combination Drugs for Treating Metastatic Castration-resistant Prostate Cancer with Tumor Mutation that Affect DNA Repair

Combination Drugs for Treating Metastatic Castration-resistant Prostate Cancer with Tumor Mutation that Affect DNA Repair

Clinicaltrials.gov identifier:
NCT03012321

Treatment
Treatment study for men with metastatic castration-resistant prostate cancer

Study Contact Information:

For additional information, please contact:

The study coordinator by phone: (312)695-1301 or by email: cancertrials@northwestern.edu

 


Combination Drugs for Treating Metastatic Castration-resistant Prostate Cancer with Tumor Mutation that Affect DNA Repair

About the Study

The goal of this study is to compare the effectiveness of three different drug combinations to treat men with castration-resistant cancer (mCRPR), who also have a mutation in a gene that affects repair found through tumor testing. 

Type of Study


This is a , study. In a study, participants are placed into one of the two study groups by chance. Neither patients nor their research doctor choose the group into which the participants are placed. In an study, all patients will know which intervention or medication they are receiving during the study.

What the Study Involves

Participants will be assigned to one of four groups. All groups will receive their treatment in 28 day cycles.

  • Groups 1, 2, and 3 will consist only of men with tumors containing mutations in , , or genes. Participants with a tumor mutation in one of these genes will be randomly assigned to one of these 3 groups
    • Group 1 will receive oral Abiraterone (once) + Prednisone (twice) daily
    • Group 2 will receive oral olaparib twice daily
    • Group 3 will receive oral Abiraterone (once) + Prednisone (twice) + Olaparib (twice) daily.
  • Group 4 will have participants with tumors containing mutations in FANCA, , RAD51, ERCC3, MRE11, , MLH3, CDK12, , HDAC2, ATR, , GEN1, , , , or FAM175A.
    • Group 4 will receive oral olaparib twice daily in 28 day cycles

Participants in single treatment groups may cross over to opposite single treatment groups if their tumor grows/disease progresses. Overall, the study goal is to determine whether the cancer grows or not after treatment. Participants will be followed for up to 2 years.

Study Sites

California

  • Los Angeles
    University of California Los Angeles
    Contact: Matthew Rettig, MD    310-268-3622          

Florida

  • Tampa
    Moffitt Cancer Center and Research Institute
    Contact: Jingsong Zhang, MD    813-745-4673      

Illinois

  • Chicago
    Northwestern Medicine
    Contact: Maha Hussain, MD    312-695-6180
  • Chicago
    Rush University Cancer Center
    Contact: Nicklas Pfanzelter, MD    312-942-5904
  • Chicago
    University of Chicago      
    Contact: Russell Szmulewitz, MD    773-702-7609
  • Evanston      
    Kellogg Cancer Center - NorthShore University
    Contact: Daniel Shevrin, MD    847-570-2515      

Indiana

  • Indianapolis
    Indiana University/ Melvin and Bren Simon Cancer Center
    Contact: Roberto Pili, MD    317-948-8310      

Maryland

  • Baltimore
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Contact: Emmanuel Antonarakis, MD    410-502-7528             

Michigan

  • Ann Arbor
    University of Michigan Health System Recruiting
    Contact: Todd Morgan, M.D.    734-647-8903        

Minnesota

  • Rochester
    Mayo Clinic
  • Contact: Manish Kohli, M.D.    507-538-3270           

Missouri

  • Saint Louis
    Washington University School of Medicine
    Contact: Joel Picus, MD    314-747-9281      

New York

  • New York
    Weill Cornell Medical College
    Contact: Himisha Beltran, MD    646-962-2072       

North Carolina

  • Chapel Hill
    University of North Carolina at Chapel Hill
    Contact: Young Whang, MD    919-966-4996         

Utah

  • Salt Lake City
    Huntsman Cancer Institute - University of Utah
    Contact: Neeraj Agarwal, MD    801-585-0100      

Virginia

  • Charlottesville
    University of Virginia
    Contact: Robert Dreicer, MD    434-924-9333      
This Study is Open To:

Men 18 years or older may participate if they meet the following: 

  • Have a diagnosis of castration-resistant cancer.
  • Have a tumor mutation in one of the following genes: , , , FANCA, , RAD51, ERCC3, MRE11, , MLH3, CDK12, , HDAC2, ATR, , GEN1, , , , or FAM175A
This Study is Not Open To:

Men may not participate if they have the following:

  • prior treatment with other PARP inhibitors 
  • prior treatment with chemotherapy for hormone resistant disease
  • other investigational treatments for hormone resistant cancer
  • an active second cancer
  • history of seizures or cancer spread to the brain 
  • history of a heart condition
  • had a bone marrow transplant 
  • must not take CYP3A4 inhibitors
  • must not have brain metastases