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NCT03047135 · ClinicalTrials.gov registry record · Phase 2

Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis

A Phase 2 study of Prostate, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Active
Registry status
Phase 2
Development phase
51
Enrollment target
4
Study locations

NCT03047135 is a Phase 2 study of Prostate that is active but no longer recruiting, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 51 participants, below the 345-participant average among 5 other Prostate trials with a reported enrollment target (85% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT03047135, a Phase 2 study of Prostate, is active but no longer recruiting, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
51 participants
Enrollment target
4
Study locations

Study Summary

Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA response, and every patient with a radiographic response also had a PSA5 response. Ten of 11 responders had mutations in DNA repair genes. While PARP inhibition is showing promise in these initial studies, reserving its use for end-stage patients may not be the optimal timing for olaparib therapy in some patients. In addition, PARP enzymes function in roles beyond DNA repair, and specifically for prostate cancer are involved transcriptional regulation of the androgen receptor. PARP inhibition has not been tested in earlier disease states for prostate cancer.

Conditions Studied

Prostate

Interventions

  • DRUG Olaparib

Study Locations (4)

Pennsylvania

  • Thomas Jefferson University - Philadelphia
  • Allegheny Cancer Center - Pittsburgh

Maryland

  • Johns Hopkins Hospital - Baltimore

Nebraska

  • University of Nebraska Medical Center - Omaha

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2017-03-01
Est. Completion 2026-05-01
Phase Phase 2

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

523 total trials

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What the Registry Record Tells You About NCT03047135

The ClinicalTrials.gov registry entry for NCT03047135 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 345-participant average among 5 other Prostate trials with a reported enrollment target (85% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate appearing as the primary indexed condition, and to 1 intervention - of which Olaparib is the first listed.

NCT03047135 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Pennsylvania, Maryland, Nebraska.

Frequently Asked Questions

What is clinical trial NCT03047135 about?

NCT03047135 is a clinical study titled "Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis". Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA response, and every patient with a radiographic response also had a PSA5 response. Ten of 11 responders had mutatio...

What is the current status of trial NCT03047135?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2017-03-01. Estimated completion is 2026-05-01.

What conditions does trial NCT03047135 study?

This clinical trial studies the following conditions: Prostate.

What interventions are being tested in trial NCT03047135?

The interventions under investigation include: Olaparib (DRUG).

Who is sponsoring clinical trial NCT03047135?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03047135 being conducted?

This trial has 4 study locations across Maryland, Nebraska, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.