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Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
NCT03012321 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Olaparib
- DRUG Prednisone
- DRUG Abiraterone Acetate
Study Locations (18)
Illinois
- Northwestern Medicine — Chicago
- Rush University Cancer Center — Chicago
- University of Chicago — Chicago
- Kellogg Cancer Center - NorthShore University — Evanston
California
- City of Hope National Medical Center — Duarte
- University of California Los Angeles — Los Angeles
Michigan
- University of Michigan Health System — Ann Arbor
- Karmanos Cancer Center — Detroit
Florida
- H. Lee Moffitt Cancer Center and Research Institute — Tampa
Indiana
- Indiana University/ Melvin and Bren Simon Cancer Center — Indianapolis
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore
Minnesota
- Mayo Clinic — Rochester
Missouri
- Washington University School of Medicine — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2017-01-12 |
| Est. Completion | 2027-01-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03012321
The ClinicalTrials.gov registry entry for NCT03012321 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,033 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Metastatic Prostate Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which Olaparib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03012321 reports 18 study locations spanning 13 distinct geographic areas — top geographies include Illinois, California, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03012321 about?
NCT03012321 is a clinical study titled "Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects". 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 ar...
What is the current status of trial NCT03012321?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2017-01-12. Estimated completion is 2027-01-16.
What conditions does trial NCT03012321 study?
This clinical trial studies the following conditions: Metastatic Prostate Carcinoma, Stage IV Prostate Cancer, Prostate Cancer Metastatic Castration-Resistant, Abnormal DNA Repair. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03012321?
The interventions under investigation include: Olaparib (DRUG), Prednisone (DRUG), Abiraterone Acetate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03012321?
This trial is sponsored by Northwestern University, which has 1,033 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03012321 being conducted?
This trial has 18 study locations across California, Florida, Illinois, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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