Clinical trialNCT03012321Active, not recruitingPhase 2Interventional

Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects

SponsorNorthwestern UniversityEnrollment70Abnormal DNA RepairMetastatic Prostate CarcinomaProstate Cancer Metastatic Castration-ResistantStage IV Prostate Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Maha Hussain, MD, FACP, FASCO
Northwestern University
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

16 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

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
University of Michigan Rogel Cancer Center
Detroit, Michigan, United States
Washington University School of Medicine
St 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Abiraterone →Olaparib →Prednisone →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 12 Jan 2017
Primary completion: 21 Oct 2023
Completion: 16 Jan 2027
Last update posted: 1 Jun 2026
Registered enrollment: 70
Registry id: NCT03012321

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.