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NCT03012321 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Metastatic Prostate Carcinoma and Stage IV Prostate Cancer, sponsored by Northwestern University.

Active
Registry status
Phase 2
Development phase
70
Enrollment target
18
Study locations

NCT03012321: Active Phase 2 study of Metastatic Prostate Carcinoma and Stage IV Prostate Cancer, sponsored by Northwestern University.

NCT03012321 is a Phase 2 study of Metastatic Prostate Carcinoma and Stage IV Prostate Cancer that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 70 participants, below the 131-participant average among 37 other Metastatic Prostate Carcinoma trials with a reported enrollment target (47% lower). The trial reports 18 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03012321, a Phase 2 study of Metastatic Prostate Carcinoma and Stage IV Prostate Cancer, is active but no longer recruiting, sponsored by Northwestern University.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
70 participants
Enrollment target
18
Study locations

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.

Primary Outcome

Evaluate the objective PFS of abiraterone/prednisone, olaparib or the combination abiraterone/prednisone + olaparib in mCRPC patients with canonical DNA repair defects in BRCA1, BRCA2, or ATM.

Conditions Studied

Metastatic Prostate Carcinoma Stage IV Prostate Cancer Prostate Cancer Metastatic Castration-Resistant Abnormal DNA Repair

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

FieldValue
Enrollment Target 70 participants
Start Date 2017-01-12
Est. Completion 2027-01-16
Phase Phase 2
Northwestern University

1,209 total trials

What the registry record for NCT03012321 still lists

NCT03012321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 131-participant average among 37 other Metastatic Prostate Carcinoma trials with a reported enrollment target (47% lower).

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.

NCT03012321 lists 18 locations in 13 states (Illinois, California, Michigan).

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.

What interventions are being tested in trial NCT03012321?

The interventions under investigation include: Olaparib (DRUG), Prednisone (DRUG), Abiraterone Acetate (DRUG).

Who is sponsoring clinical trial NCT03012321?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Metastatic Prostate Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03012321's enrollment target sits among peer trials

70 17th of 37 higher than 21 of 37 other Metastatic Prostate Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Prostate Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03012321, the US trial registry maintained by the National Library of Medicine. NCT03012321 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.