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

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 b

Trial Details

NCT ID
NCT07027124
Phase
PHASE2
Sponsor
Icahn School of Medicine at Mount Sinai
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Darolutamide
  • Pembrolizumab
  • Lupron
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Male Age ≥ 18 years at the time of consent
  • Subjects must have histopathologically confirmed adenocarcinoma of the prostate
  • Subjects must have unfavorable intermediate and high-risk localized or locally advanced prostate cancer (Gleason score ≥7 (4+3) and absence of dist…
  • Subjects must be risk-stratified at biopsy and their cancer should have all the molecular features given below at baseline.

For full eligibility, visit ClinicalTrials.gov.

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