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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 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.

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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.

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

Sponsor

Northwestern University

1,209 total trials

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What the Registry Record Tells You About NCT03012321

The ClinicalTrials.gov registry entry for NCT03012321 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 131-participant average among 37 other Metastatic Prostate Carcinoma trials with a reported enrollment target (47% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

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 reports 18 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.