Study on Prostate Cancer Treatment Using Hormone Therapy and Targeted Prostate Surgery

Sponsor: University of Chicago

Sponsor score: 0

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

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

FACILITYZIPCITYSTATE
UChicago Medicine Comprehensive Cancer Center60637ChicagoIllinois

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