Pilot Study of REGN5678 for High-Risk Prostate Cancer Before Surgery

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06085664

Provider View

This clinical trial is exploring the safety and effects of a new drug, REGN5678, in men with high-risk prostate cancer who are scheduled for surgery. The study aims to see how well the drug works and how it affects the immune system.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effects of a new drug called REGN5678 in men with high-risk prostate cancer. Researchers want to see if the drug is safe and if it can help reduce cancer in the prostate. They will also look at how the drug affects the immune system and use special imaging tests to see how the drug works in the body.

Description

This study is focused on evaluating a new drug, REGN5678, for men with high-risk prostate cancer who are planning to have surgery. The main goals are to ensure the drug is safe and to see if it can help reduce the cancer. Researchers will also study how the drug affects the immune system and use imaging tests to understand its impact on the cancer.

Participants must meet certain health criteria and agree to follow study procedures, including using birth control during the study and for three months after. The study will involve regular clinic visits and tests to monitor health and the drug's effects.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Diagnosed with high-risk prostate cancer, specifically Gleason score 8 or higher, confirmed by recent biopsy.
  • Good overall health with an ECOG performance status of 0 or 1.
  • No signs of cancer spread to other parts of the body based on recent scans.
  • Cancer that can be surgically removed, and candidates for prostate surgery with lymph node removal.
  • No previous treatments for prostate cancer, except for certain minor procedures.
  • Meet specific blood test requirements for hemoglobin, neutrophil count, platelet count, kidney, and liver function.
  • Willing to follow study procedures and provide informed consent.
  • Agree to use condoms during sexual activity and avoid sperm donation during the study and for three months after.

Exclusion Criteria

  • Previous hormone therapy for prostate cancer.
  • Participation in another clinical trial.
  • Use of certain medications like high-dose steroids or immunosuppressive drugs recently.
  • History of autoimmune diseases, except for certain conditions like vitiligo or controlled thyroid disorders.
  • Active infections requiring treatment, such as HIV or hepatitis, unless well-controlled.
  • Significant heart problems or recent heart-related events.
  • Recent major surgery or history of certain implants or devices.
  • Other cancers within the last two years, except for certain skin or bladder cancers.
  • Neurological conditions like encephalitis or uncontrolled seizures.
  • Lung diseases or recent live vaccinations.
  • Previous stem cell or organ transplants.
  • Any condition that might interfere with participation in the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.