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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
Clinicaltrials.gov identifier:
NCT03012321
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: [email protected]
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 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. NOTE: This study is now closed.
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 + prednisone daily
- Group 2 will receive oral daily
- Group 3 will receive oral + prednisone + 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 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 CenterContact: 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
NOTE: This study is now closed.
NOTE: This study is now closed.