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 metastatic castration-resistant prostate cancer, (mCRPC) who also have an inherited mutation or a tumor mutation in a gene that affects DNA 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: ATM, BRCA1, BRCA2, FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A. NOTE: This study is now closed. 

Type of Study

This is a phase 2, randomized, open-label study.

• In a randomized 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 open-label 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 ATM, BRCA1, or BRCA2 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, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, 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