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

Recruiting Phase 2 Interventional Study
Prostate Cancer High-risk Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Icahn School of Medicine at Mount Sinai · Other
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About This 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). Patien…
Trial Locations
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Eligibility Criteria
Inclusion 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 distant…
Contacts

Daniela Delbeau- Zagelbaum, RN, NP

212 241 2066

daniela.delbeau-zagelbaum@mssm.edu

CONTACT

Monali Fatterpekar, PhD

212 241 0751

monali.fatterpekar@mountsinai.org

CONTACT