Study on Neoadjuvant ADT, Darolutamide, and Pembrolizumab for High-Risk Prostate Cancer

Sponsor: Icahn School of Medicine at Mount Sinai

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07027124

Provider View

This clinical trial is testing a combination of hormone therapy, Darolutamide, and Pembrolizumab before surgery, followed by additional Pembrolizumab treatment, in men with high-risk prostate cancer. The study aims to see if this approach can reduce cancer before surgery and improve outcomes.

Patient Parameters

Program Overview

This study is exploring a treatment plan for men with high-risk prostate cancer that has not spread to other parts of the body. The treatment involves using hormone therapy (ADT), Darolutamide, and Pembrolizumab before surgery to see if it can reduce the cancer. After surgery, patients will continue to receive Pembrolizumab to help prevent the cancer from returning. The study focuses on patients whose cancer has specific genetic characteristics that make it high-risk.

Description

The main goal of this study is to find out if using a combination of hormone therapy, Darolutamide, and Pembrolizumab before surgery can help reduce the amount of cancer in men with high-risk prostate cancer. After surgery, patients will receive Pembrolizumab for additional cycles to help prevent the cancer from coming back. The study will include 40 men aged 18 and older who have high-risk prostate cancer based on specific genetic tests. These tests will help identify patients whose cancer is more likely to benefit from this treatment approach. Participants will be monitored closely to see how well the treatment works and to check for any side effects.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years or older.
  • Diagnosed with prostate cancer that is high-risk but has not spread to other parts of the body.
  • Cancer must meet specific criteria, such as a Gleason score of 8 or higher, PSA level over 20 ng/mL, or advanced clinical stage.
  • Cancer must have certain genetic features based on specific tests.
  • Good overall health with a performance status of 0 or 1.
  • Previous hormone therapy is allowed if completed over 12 months ago and the patient has recovered from any side effects.
  • Must have adequate organ and bone marrow function based on blood tests.
  • Men must agree to use condoms and not father a child during the study and for 90 days after.
  • Must be able to understand and sign a consent form.
  • Participants with controlled hepatitis B or C, or HIV with undetectable viral load, are eligible.

Exclusion Criteria

  • Cancer that has spread to other parts of the body.
  • Gleason score less than 8.
  • Previous hormonal therapy, radiation, or chemotherapy for prostate cancer (with some exceptions).
  • Recent heart problems or active heart disease.
  • Active gastrointestinal issues affecting drug absorption.
  • Inability to swallow pills.
  • Recent infections requiring treatment.
  • Previous treatment with certain immune therapies.
  • Active hepatitis B or C, or HIV with detectable viral load.
  • History of tuberculosis or lung inflammation.
  • Use of high-dose steroids or other immune-suppressing drugs.
  • Active autoimmune disease requiring treatment in the past 2 years.
  • Conditions that could interfere with study results.
  • Known brain metastases or severe allergies to study drugs.

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