Study on Anti-Testosterone Medications and Radiation for High-Risk Prostate Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02772588

This clinical trial is exploring whether using anti-testosterone medications before, during, and after high-dose precision radiation can help prevent prostate cancer from returning in patients with high-risk prostate cancer.

Patient Parameters

Program Overview

The aim of this study is to find out if anti-testosterone medications, when used alongside high-dose precision radiation, can effectively stop prostate cancer from coming back in patients who are considered high-risk. The study will involve administering these medications before, during, and after radiation treatment to see if this approach can improve outcomes for patients.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of prostate cancer.
  • Must have at least one high-risk feature, such as a Gleason score of 8-10, PSA level of 20 or higher, or advanced clinical stage.
  • Must be in good general health with a performance status score of 70% or higher.
  • Must have normal liver and kidney function based on specific blood tests.
  • Must have adequate blood cell counts and other lab values.
  • Must be willing to provide informed consent and follow study procedures.
  • Men aged 18 and older.
  • Must agree to use effective contraception during the study and for three months after.
  • Must not donate sperm during the study and for three months after.

Exclusion Criteria

  • Evidence of cancer spread to other parts of the body.
  • Previous treatment for prostate cancer, except for certain hormone therapies.
  • Use of certain medications that affect hormone levels or the immune system within a specified time before the study.
  • History of other cancers within the last three years, except for certain skin cancers or early-stage cancers in remission.
  • Severe liver problems or other serious health conditions.
  • Recent major surgery or presence of a pacemaker.
  • Active infections or medical conditions that would make certain medications unsafe.
  • History of heart problems, seizures, or other conditions that could increase risk during the study.
  • Uncontrolled diabetes, heart disease, or high blood pressure.
  • Gastrointestinal issues that could affect medication absorption.
  • Participation in another drug study within four weeks of this study.

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