Spots Global Cancer Trial Database for Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
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Trial Identification
Brief Title: Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
Official Title: BRCAAway: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
Study ID: NCT03012321
Study Description
Brief Summary: This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a 1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
University of California Los Angeles, Los Angeles, California, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Northwestern Medicine, Chicago, Illinois, United States
Rush University Cancer Center, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Kellogg Cancer Center - NorthShore University, Evanston, Illinois, United States
Indiana University/ Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Karmanos Cancer Center, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Weill Cornell Medical College, New York, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Huntsman Cancer Institute - University of Utah, Salt Lake City, Utah, United States
University of Virginia, Charlottesville, Virginia, United States
Contact Details
Name: Maha Hussain, MD, FACP, FASCO
Affiliation: Northwestern University
Role: PRINCIPAL_INVESTIGATOR
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