CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 32 target
Drug / intervention
Olaparib +1 moredrug
Likely dose
Olaparib 300 mgfrom record
Key inclusion· 11
  • ✓Age ≥18 years at time of consent
  • ✓T stage 1-3 prostatic adenocarcinoma per AJCC staging
  • ✓Histologically confirmed adenocarcinoma without >50% histological variants
  • ✓≥3 core biopsies involved with cancer from ≥6 total cores, or <3 if >1cm or T3 disease on MRI
Key exclusion· 24
  • ✕Active infection requiring systemic therapy
  • ✕Prior hormone therapy including orchiectomy, antiandrogens, CYP17 inhibitors, estrogens, and radiation therapy
  • ✕Prior bicalutamide allowed only if <4 weeks prior to registration with 2-week washout
  • ✕LHRH agonist/antagonist allowed if begun within 4 weeks of registration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05498272
NCT05498272Phase 2RecruitingMonitorUpdated 5mo ago · Completion was 4mo ago
Slow Enrollment
Long Recruiting
Monitor
CompareCT.gov

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)

Rana McKay, MD·interventional·Posted Aug 12, 2022·Updated Jan 23, 2026

In Brief

A Phase 2 clinical trial evaluating Olaparib and LHRH agonist for Prostate Cancer and 4 related conditions. Currently recruiting, targeting 32 participants across 6 sites.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, BRCA1 Mutation, BRCA2 Mutation, Prostatic Adenocarcinoma, High-Risk Cancer
CountriesUnited States
CollaboratorsAstraZeneca, University of California, San Diego

Timeline

Phase 2Recruiting
20232024202520262027
First PostedAug 12, 2022
Enrollment StartFeb 1, 2023
Primary CompletionMar 1, 2026
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 3.9 years ago

Interventions

Olaparibdrug

300 mg orally twice a day (D1-D30) for 6 Cycles (30 day Cycles)

LHRH agonistdrug

Total duration of therapy will be for 180 days with use of agent as per institutional standards