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NCT07027124 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Prostate Cancer and High-risk Prostate Cancer, sponsored by Icahn School of Medicine at Mount Sinai.

Recruiting
Registry status
Phase 2
Development phase
40
Enrollment target
1
Study location

NCT07027124 is a Phase 2 study of Prostate Cancer and High-risk Prostate Cancer that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 40 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07027124, a Phase 2 study of Prostate Cancer and High-risk Prostate Cancer, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.

RECRUITING
Registry status
Phase 2
Development phase
40 participants
Enrollment target
1
Study location

Study 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). 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

Conditions Studied

Prostate Cancer High-risk Prostate Cancer

Interventions

  • DRUG Pembrolizumab
  • DRUG Darolutamide
  • DRUG Lupron

Study Locations (1)

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2026-03-19
Est. Completion 2031-05-02
Phase Phase 2

Sponsor

Icahn School of Medicine at Mount Sinai

708 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07027124

The ClinicalTrials.gov registry entry for NCT07027124 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT07027124 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT07027124 about?

NCT07027124 is a clinical study titled "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, fo...

What is the current status of trial NCT07027124?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2026-03-19. Estimated completion is 2031-05-02.

What conditions does trial NCT07027124 study?

This clinical trial studies the following conditions: Prostate Cancer, High-risk Prostate Cancer.

What interventions are being tested in trial NCT07027124?

The interventions under investigation include: Pembrolizumab (DRUG), Darolutamide (DRUG), Lupron (DRUG).

Who is sponsoring clinical trial NCT07027124?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07027124 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.