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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

Study acronym: NePtune
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 10, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Primary completion pushed from Mar 2026 to Aug 2026 · Site details revised at 6 of 6 sitesv18 Show 2 more changesShow less
    • Primary completion pushed from Mar 2026 to Aug 2026
    • Site details revised at 6 of 6 sites
  2. Primary completion date: Dec 2025 to Mar 2026v17
  3. Study sites: 5 to 6v16
  4. Re-verified, no change to tracked fieldsv15
  5. Eligibility criteria shortened, about 23 words Study title expanded, about 1 wordv14 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 4 to 5v13
  2. Site contacts updated at 1 of 4 sitesv12
  3. Site contacts updated at 1 of 4 sitesv11
  4. Primary completion date: Dec 2023 to Dec 2025 Completion date: Dec 2024 to Dec 2026v10 Show 1 more changeShow less
    • Completion date: Dec 2024 to Dec 2026
  5. Study sites: 3 to 4v9
  6. Study sites: 2 to 3v8
  7. Study sites: 1 to 2v7
  8. Secondary endpoints revised (10)v6 See this version in full on ClinicalTrials.gov ↗
  9. 2 versions Re-verified since Feb 27, 2023, no change to tracked fieldsv4-v5
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jul 2023 to Feb 1, 2023v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2023 to Feb 1, 2023
  11. Start date: Dec 2022 to Jul 2023 Primary completion date: Jul 2023 to Dec 2023 · Completion date: Jul 2024 to Dec 2024v2 Show 2 more changesShow less
    • Primary completion date: Jul 2023 to Dec 2023
    • Completion date: Jul 2024 to Dec 2024
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Rana McKay, MD
2 trials monitored
See 1 trial at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
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.
Trial Details
NCT Number NCT05498272
Lead Sponsor Rana McKay, MD
Collaborators: AstraZeneca, University of California, San Diego
Conditions Prostate Cancer, BRCA1 Mutation, BRCA2 Mutation, Prostatic Adenocarcinoma, High-Risk Cancer
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov