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ACTIVE NOT RECRUITING Phase 2

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

NCT04030559 · View on ClinicalTrials.gov ↗

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.

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

29 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04030559

The ClinicalTrials.gov registry entry for NCT04030559 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 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Marc Dall'Era, MD, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT04030559 reports 1 study location spanning 1 distinct geographic area — top geographies include California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04030559?

The interventions under investigation include: Radical Prostatectomy (PROCEDURE), Niraparib (DRUG), Niraparib Tosylate Monohydrate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04030559?

This trial is sponsored by Marc Dall'Era, MD, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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