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Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 53 words
    • Secondary endpoints: details revised at 4 of 9 entries
    • Collaborators: details revised at 1 of 2 entries
  2. Primary completion pushed from Dec 1, 2026 to Dec 1, 2027
    • Start date: Mar 19, 2026 to May 21, 2026
    • Eligibility criteria shortened, about 22 words
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 2025 to Mar 19, 2026
    • Site details revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a single-arm, phase II study of neoadjuvant combination therapy of Androgen Deprivation Therapy (ADT), \[Gonadotropin-Releasing Hormone (GnRH) agonist Leuprolide\], androgen receptor (AR)-antagonist Darolutamide and Pembrolizumab in a stratified high-risk localized prostate cancer cohort, followed by adjuvant treatment with Pembrolizumab (12 cycles) post-radical prostatectomy (RP). Patients with National Comprehensive Cancer Network (NCCN) high-risk non-metastatic prostate cancer (localized or locally advanced) (defined as Gleason ≥8, disease stage \>=cT3a, or PSA l \>20 ng/mL) will be risk-stratified at a biopsy using Decipher, a commercial standard-of-care diagnostic assay. Patients satisfying all three criteria of high-risk genomic characteristics listed below as per the Decipher grid results will be enrolled in the study: 1. Decipher Genomic classifier, GC\>0.6 2. AR activity score/AR-output gene signature (ARoS)\>11.0 3. High Luminal B score/ PAM50 subtype signature
Trial Details
NCT Number NCT07027124
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: Merck Sharp & Dohme LLC, Bayer
Conditions
(from sponsor)		 Prostate Cancer, High-risk Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov