Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Rana R. McKay, MD (ucsd)
Headshot of Rana R. McKay
Rana R. McKay

Description

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.

Official Title

A 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 (NePtune)

Keywords

Prostate Cancer, BRCA1 Mutation, BRCA2 Mutation, Prostatic Adenocarcinoma, High-Risk Cancer, Prostatic Neoplasms, Olaparib, Leuprolide, Goserelin, Triptorelin Pamoate, LHRH agonist

Eligibility

Locations

  • University of California San Diego - Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center accepting new patients
    Baltimore Maryland 21287 United States

Lead Scientist at University of California Health

  • Rana R. McKay, MD (ucsd)
    Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 328 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rana McKay, MD
ID
NCT05498272
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 32 study participants
Last Updated