Study on Prostate Cancer Treatment Using Hormone Therapy and Targeted Prostate Surgery
Sponsor: University of Chicago
ClinicalTrials ID:NCT05790213
This clinical trial is exploring the safety and effectiveness of combining hormone therapy with a targeted surgical procedure to treat prostate cancer. The study aims to determine if this combination can effectively manage prostate cancer in men with intermediate-risk levels.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of combining two treatments for prostate cancer: hormone therapy, which reduces male hormones that can fuel cancer growth, and focal prostate ablation, a targeted surgical procedure that removes cancerous tissue. This study is for men with intermediate-risk prostate cancer who have chosen to undergo this combination treatment.
Eligibility Criteria
Inclusion Criteria
- Men with intermediate-risk prostate cancer, either favorable or unfavorable, based on specific medical criteria.
- No evidence of cancer spreading beyond the prostate or into the seminal vesicles, as confirmed by imaging tests.
- Must have chosen to undergo focal therapy for prostate cancer treatment.
- Confirmed non-metastatic prostate cancer through standard imaging tests for those with unfavorable intermediate-risk cancer.
- Men aged 18 years or older.
- Expected to live at least 10 more years, according to the treating doctor.
- In good general health, with a performance status score indicating ability to carry out daily activities.
- Fit for general anesthesia and the surgical procedure, with good visualization of the prostate on ultrasound and tolerance for the required positioning during surgery.
- Adequate organ and blood function, as shown by specific blood test results.
- Men with other cancers that do not interfere with the study treatment are eligible.
- Sexually active men must agree to use condoms and their partners must use effective contraception during and for three months after treatment.
- Must understand and agree to sign a consent form to participate in the study.
Exclusion Criteria
- Men who have had previous treatments for prostate cancer, such as surgery, radiation, or hormone therapy.
- Men with advanced prostate cancer that has spread to lymph nodes or other parts of the body.
- Men who cannot undergo MRI scans due to medical conditions or allergies.
- History of allergy to study drug components.
- History of removal of both testicles.
- Men with uncontrolled or severe illnesses.
- Men currently receiving or who have recently received other experimental treatments, unless approved by the study doctor.
- Men deemed unsuitable for the study by the treating doctor or unlikely to follow study procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UChicago Medicine Comprehensive Cancer Center | 60637 | Chicago | Illinois |
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