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

NCT07027124

This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .

Summary

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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Prostate Cancer
  • High-risk Prostate Cancer

Eligibility basics and study details

Study type
Interventional
Phase
Phase 2
Ages
18 years and older
Sex
Male
Healthy volunteers
Not accepted
Sponsor
Icahn School of Medicine at Mount Sinai
Last updated on ClinicalTrials.gov
October 7, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

New York · 1

  • Icahn School of Medicine at Mount Sinai · New York, NY

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.