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RECRUITING 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

NCT05498272 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 32 participants
Start Date 2023-02-01
Est. Completion 2026-12
Phase Phase 2

Sponsor

Rana McKay, MD

2 total trials

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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. 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 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rana McKay, MD, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT05498272 reports 6 study locations spanning 5 distinct geographic areas — top geographies include New York, California, Maryland. 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 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, Prostatic Adenocarcinoma, High-Risk Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05498272?

The interventions under investigation include: Olaparib (DRUG), LHRH agonist (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05498272?

This trial is sponsored by Rana McKay, MD, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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