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NCT04030559 · ClinicalTrials.gov registry record · Phase 2

Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects

A Phase 2 study of ATM Gene Mutation and BRCA1 Gene Mutation, sponsored by Marc Dall'Era, MD.

Active
Registry status
Phase 2
Development phase
11
Enrollment target
1
Study location

NCT04030559 is a Phase 2 study of ATM Gene Mutation and BRCA1 Gene Mutation that is active but no longer recruiting, run by Marc Dall'Era, MD. The registered enrollment target is 11 participants, below the 284-participant average among 6 other ATM Gene Mutation trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04030559, a Phase 2 study of ATM Gene Mutation and BRCA1 Gene Mutation, is active but no longer recruiting, sponsored by Marc Dall'Era, MD.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
11 participants
Enrollment target
1
Study location

Study Summary

This phase II trial studies how well niraparib, when given before surgery, works in treating patients with high risk prostate cancer that has not spread to other parts of the body (localized) and alterations in deoxyribonucleic acid (DNA) repair pathways. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions Studied

ATM Gene Mutation BRCA1 Gene Mutation BRCA2 Gene Mutation BRIP1 Gene Mutation CHEK2 Gene Mutation CDK12 Gene Mutation CHEK1 Gene Mutation DNA Damage Response Gene Mutation DNA Repair Gene Mutation FANCA Gene Mutation

Interventions

  • PROCEDURE Radical Prostatectomy
  • DRUG Niraparib
  • DRUG Niraparib Tosylate Monohydrate

Study Locations (1)

California

  • University of California Davis Comprehensive Cancer Center - Sacramento

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2020-02-25
Est. Completion 2025-12
Phase Phase 2

Sponsor

Marc Dall'Era, MD

2 total trials

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What the Registry Record Tells You About NCT04030559

The ClinicalTrials.gov registry entry for NCT04030559 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 6 other ATM Gene Mutation trials with a reported enrollment target (96% lower). The listed sponsor is Marc Dall'Era, MD, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with ATM Gene Mutation appearing as the primary indexed condition, and to 3 interventions - of which Radical Prostatectomy is the first listed.

NCT04030559 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT04030559 about?

NCT04030559 is a clinical study titled "Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects". This phase II trial studies how well niraparib, when given before surgery, works in treating patients with high risk prostate cancer that has not spread to other parts of the body (localized) and alterations in deoxyribonucleic acid (DNA) repair pathways. Niraparib may stop the growth of tumor cells...

What is the current status of trial NCT04030559?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2020-02-25. Estimated completion is 2025-12.

What conditions does trial NCT04030559 study?

This clinical trial studies the following conditions: ATM Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation, CHEK2 Gene Mutation.

What interventions are being tested in trial NCT04030559?

The interventions under investigation include: Radical Prostatectomy (PROCEDURE), Niraparib (DRUG), Niraparib Tosylate Monohydrate (DRUG).

Who is sponsoring clinical trial NCT04030559?

This trial is sponsored by Marc Dall'Era, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04030559 being conducted?

This trial has 1 study location across California. 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.