Study on Anti-Testosterone Medications and Radiation for High-Risk Prostate Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
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
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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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