Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyzna w wieku 18 lat i starszy
- •Potwierdzony histologicznie rak gruczołowy prostaty
- •Zaawansowany rak prostaty bez przerzutów odległych
- •Wyniki testu genetycznego (Decipher) wskazujące na wysoke ryzyko
- •Dobry stan ogólny (możliwość normalnego funkcjonowania)
- •Prawidłowe wyniki badań krwi i funkcja nerek i wątroby
- •Gotowość do stosowania antykoncepcji przez cały okres badania i 90 dni po
- •Podpisana zgoda na uczestnictwo w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 7, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Icahn School of Medicine at Mount Sinai
New York, United States
Trial contact
Daniela Delbeau- Zagelbaum, RN, NP
Monali Fatterpekar, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/8/2026.
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