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Abiraterone/Prednisone and Olaparib Alone or In Combination for Treatment of Metastatic Castration-Resistant Prostate Cancer With Mutations Related to DNA Repair

Abiraterone/Prednisone and Olaparib Alone or In Combination for Treatment of Metastatic Castration-Resistant Prostate Cancer With Mutations Related to DNA Repair

Clinicaltrials.gov identifier:
NCT03012321

Treatment
Men with mCRPC with an inherited mutation or a tumor mutation in a DNA damage repair gene

Study Contact Information:

Study coordinator  (312)695-1301 or by email at: cancertrials@northwestern.edu           
Principal Investigator: Maha Hussain, MD, Northwestern University


Abiraterone/Prednisone and Olaparib Alone or In Combination for Treatment of Metastatic Castration-Resistant Prostate Cancer With Mutations Related to DNA Repair

About the Study

This study will comparing three different treatments for men with castration-resistant cancer, (mCRPC) who also have an inherited mutation or a tumor mutation in a gene that affects damage repair. The study is open to men with inherited mutations found on genetic testing or acquired mutations found on tumor testing in one of the following genes: , , , FANCA, , RAD51, ERCC3, MRE11, , MLH3, CDK12, , HDAC2, ATR, , GEN1, , , , or FAM175A.

Type of Study

This is a phase 2, , 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 divided into one of four groups.

Groups 1, 2, and 3 will consist only of men with inherited or tumor 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 + prednisone daily
  • Group 2 will receive oral olaparib daily
  • Group 3 will receive oral abiraterone + prednisone + olaparib daily

Participants with inherited or tumor mutations in FANCA, , RAD51, ERCC3, MRE11, , MLH3, CDK12, , HDAC2, ATR, , GEN1, , , , or FAM175A genes will be placed into group 4.

  • Group 4 will receive oral olaparib daily

Participants will be followed for 2 years.
 

Study Sites

California

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

Florida

  • Tampa
    H. Lee Moffitt Cancer Center and Research Institute       
    Contact: Jingsong Zhang, MD by phone at: 813-745-4673     
    Lead researcher: Jingsong Zhang, MD      

Illinois

  • Chicago
    Contact: Maha Hussain, MD by phone: 312-695-6180     
    Lead researchers: Maha Hussain, MD and Alicia K. Morgans, MD, MPH  
  • Chicago
    Rush University Cancer Center

    Contact: Nicklas Pfanzelter, MD by phone: 312-942-5904     
    Lead researcher: Nicklas Pfanzelter, MD 

  • Chicago
    University of Chicago          
    Contact: Russell Szmulewitz, MD by phone: 773-702-7609     
    Lead researcher: Russell Szmulewitz, MD

  • Evanston         
    Kellogg Cancer Center - NorthShore University   
    Contact: Daniel Shevrin, MD by phone: 847-570-2515     
    Lead researcher: Daniel Shevrin, MD     

Indiana

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

Maryland

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

Michigan

  • Ann Arbor
    University of Michigan Health System  
    Contact: Todd Morgan, MD by phone: 734-647-8903     
    Lead researchers: Todd Morgan, MD; Zachery Reichert, MD, PhD; Arul Chinnaiyan, MD, PhD and Scott Tomlins, MD, PhD     

Minnesota

  • Rochester
    Mayo Clinic
    Contact: Manish Kohli, MD by phone: 507-538-3270     
    Lead researcher: Manish Kohli, MD   

Missouri

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

New York

  • New York City
    Weill Cornell Medical College
    Contact: Himisha Beltran, MD by phone: 646-962-2072     
    Lead researcher: Himisha Beltran, MD   

North Carolina

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

Utah

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

Virginia

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

Men 18 years or older who meet the following criteria:

  • have a diagnosis of castration-resistant cancer.
  • have a mutation found on testing of tumor tissue or inherited mutation found on genetic testing in one of the following genes:
    • , , , FANCA, , RAD51, ERCC3, MRE11, , MLH3, CDK12, , HDAC2, ATR, , GEN1, , , , or FAM175A.
  • willing to undergo a fresh biopsy of tissue if needed to confirm tumor mutation (additional biopsy may not be needed if past genetic testing or tumor testing found one of the above mutations. 

 

This Study is Not Open To:

People may not participate if they:

  • had prior treatment with chemotherapy in the castration-resistant setting
  • have an active second cancer
  • have a history of seizures or cancer spread to the brain
  • have a history of a heart condition
  • had a bone marrow transplant