Focal Therapy for Prostate Cancer Using HIFU

Launched by UNIVERSITY COLLEGE, LONDON · Sep 2, 2010

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called high-intensity focused ultrasound (HIFU) for prostate cancer. The goal is to see if this method can safely destroy cancer cells while helping men maintain important functions, like being able to have erections and control their urinary function. Previous studies showed promising results, but they involved small groups of men who were generally healthy. This trial aims to include a larger and more diverse group of men to better understand how effective HIFU can be for a wider range of patients.

To be eligible for the trial, participants must be men diagnosed with prostate cancer confirmed by a biopsy. They should have a specific type of cancer that meets certain criteria, including the cancer being at stage T1 to T2c and having a PSA level of 20 ng/ml or lower. Participants also need to be in good health with a life expectancy of at least 10 years. Those who join the study will receive the HIFU treatment and will be monitored closely to see how well it works and to track any side effects. This is a great opportunity for eligible men to potentially benefit from a new approach to treating prostate cancer while contributing to important research.

Gender

MALE

Eligibility criteria

• • 1. Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies.
• 2. Prostate biopsy (either TRUS or MRI Targeted or Template):
• • TRUS biopsy: up to burden bilateral disease with maximum 3mm one biopsy on non-dominant side is allowable.
• * MRI targeted and/or Template biopsy within 12 months of entry showing:
• • unilateral disease minimum 3mm of Gleason 3+3 or any Gleason 3+4 or 4+3 but not exceeding Gleason 4+3 overall OR
• • bilateral disease presence of clinically significant cancer on only one side (as determined by histological rules described above) Gleason ≤7 which is concordant with the MRI findings.
• • 3. Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted).
• • 4. Serum PSA \</=20ng/ml
• • 5. Life expectancy of \>/=10 years.
• • 6. Signed informed consent by patient.
• • 7. An understanding of the English language sufficient to understand