Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With BRCA1/2 Gene Alterations — NePtune  

Prostate Cancer Clinical Trial

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 BRCA1/2 Gene Alterations (NePtune)

Status Recruiting

Clinical Trial 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 BRCA1/2 gene mutation. 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• BRCA1 Mutation
• BRCA2 Mutation
• High-Risk Cancer
• Prostate Cancer
• Prostatic Adenocarcinoma
• Prostatic Neoplasms

• NCT number: NCT05498272
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Contact: Rana R. McKay, MD
• Phone: 858-822-6185
• Email: rmckay@ucsd.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2023
• Completion date: December 2026