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NCT05498272 · ClinicalTrials.gov registry record · Phase 2
Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations
A Phase 2 study of Prostate Cancer and BRCA1 Mutation, sponsored by Rana McKay, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 6
- Study locations
NCT05498272 is a Phase 2 study of Prostate Cancer and BRCA1 Mutation that is actively recruiting participants, run by Rana McKay, MD. The registered enrollment target is 32 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT05498272, a Phase 2 study of Prostate Cancer and BRCA1 Mutation, is actively recruiting participants, sponsored by Rana McKay, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 6
- Study locations
Study Summary
Phase 2 open-label, single-arm clinical trial evaluating the efficacy and safety of neoadjuvant olaparib + LHRH agonist administered for 6 months prior to radical prostatectomy (RP) in men with unfavorable intermediate-risk or high-risk localized prostate cancer. All patients must have confirmed germline or somatic select HRR alterations. Germline and somatic mutation testing will be performed as part of commercially available CLIA assays and will be validated on a uniform platform centrally all patients retrospectively. Eligible patients will receive treatment with olaparib + LHRH agonist. Following 6 months of therapy, patients will undergo RP with mandatory lymph node dissection. The lymph node dissection template will be at the discretion of the treating urologist. RP specimens will undergo pathology blinded independent central review. Following RP, patients will be followed for testosterone recovery and PSA progression.
Conditions Studied
Interventions
- DRUG Olaparib
- DRUG LHRH agonist
Study Locations (6)
New York
- Columbia University Irving Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
California
- University of California San Diego - Moores Cancer Center - La Jolla
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore
Ohio
- University of Cincinnati - Cincinnati
Pennsylvania
- Penn Medicine Abramson Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05498272
The ClinicalTrials.gov registry entry for NCT05498272 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Rana McKay, MD, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Olaparib is the first listed.
NCT05498272 reports 6 study locations spanning 5 distinct geographic areas - top geographies include New York, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT05498272 about?
NCT05498272 is a clinical study titled "Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations". Phase 2 open-label, single-arm clinical trial evaluating the efficacy and safety of neoadjuvant olaparib + LHRH agonist administered for 6 months prior to radical prostatectomy (RP) in men with unfavorable intermediate-risk or high-risk localized prostate cancer. All patients must have confirmed ger...
What is the current status of trial NCT05498272?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2023-02-01. Estimated completion is 2026-12.
What conditions does trial NCT05498272 study?
This clinical trial studies the following conditions: Prostate Cancer, BRCA1 Mutation, BRCA2 Mutation, High-Risk Cancer, Prostatic Adenocarcinoma.
What interventions are being tested in trial NCT05498272?
The interventions under investigation include: Olaparib (DRUG), LHRH agonist (DRUG).
Who is sponsoring clinical trial NCT05498272?
This trial is sponsored by Rana McKay, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05498272 being conducted?
This trial has 6 study locations across California, Maryland, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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