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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 BRCA1 Gene Mutation and BRCA2 Gene Mutation, sponsored by Marc Dall'Era, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT04030559: Active Phase 2 study of BRCA1 Gene Mutation and BRCA2 Gene Mutation, sponsored by Marc Dall'Era, MD.
NCT04030559 is a Phase 2 study of BRCA1 Gene Mutation and BRCA2 Gene Mutation that is active but no longer recruiting, run by Marc Dall'Era, MD. The registered enrollment target is 11 participants, below the 573-participant average among 7 other BRCA1 Gene Mutation trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04030559, a Phase 2 study of BRCA1 Gene Mutation and BRCA2 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.
Primary Outcome
Number of participants who achieve complete pathologic response defined as no tumor identified on hematoxylin and eosin (H\&E) stained sections in participants who receive neoadjuvant niraparib therapy prior to radical prostatectomy (RP).
Conditions Studied
Interventions
- PROCEDURE Radical Prostatectomy
- DRUG Niraparib
- DRUG Niraparib Tosylate Monohydrate
Study Locations (1)
California
- University of California Davis Comprehensive Cancer Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-02-25 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT04030559 still lists
NCT04030559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 573-participant average among 7 other BRCA1 Gene Mutation trials with a reported enrollment target (98% lower).
The record links to 10 conditions, with BRCA1 Gene Mutation appearing as the primary indexed condition, and to 3 interventions - of which Radical Prostatectomy is the first listed.
NCT04030559 reports a single indexed study location in 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: BRCA1 Gene Mutation, BRCA2 Gene Mutation, ATM 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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