Focal Therapy for Prostate Cancer Using HIFU
A Multi-Center Prospective Single Arm Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound (Sonablate 500) for Localized Prostate Cancer
About This Trial
- This clinical trial is testing a targeted treatment called high-intensity focused ultrasound (HIFU), which uses sound waves to destroy only the cancerous area of the prostate rather than treating the entire gland.
- It is designed for men with localized prostate cancer that has not spread and is primarily contained to one side of the prostate.
- The goal is to learn how well this approach controls cancer while protecting everyday quality of life, such as normal bladder control and sexual function.
- Before considering this trial, patients should know they will need recent biopsy and imaging results showing their cancer fits specific stage and tumor-size limits.
More Information
- RATIONALE: Prospective trials using hemi-ablation with high intensity focused ultrasound (HIFU) (Sonablate 500) have demonstrated feasibility, safety, and encouraging functional outcomes and early cancer control with 90% of men achieving trifecta status (no erectile dysfunction, leak-free pad-free continence, cancer control).
- However, these trials have involved small numbers of patients with men selected for good baseline function.
- A multi-centre prospective trial within a larger cohort of men that better represents the patient population with prostate cancer (external validity) is required.
Who Can Enroll
- Age Range: up to 90 years
- Gender: Male
- Who This Trial is For: This clinical trial is testing a targeted treatment called high-intensity focused ultrasound (HIFU), which uses sound waves to destroy only the cancerous area of the prostate rather than treating the entire gland.
Study Details
- Start Date: June 29, 2011
- Lead Sponsor: University College, London
Full Eligibility Criteria
- Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies.
- 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.
- Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted).
- Serum PSA </=20ng/ml
- Life expectancy of >/=10 years.
- Signed informed consent by patient.
- An understanding of the English language sufficient to understand
- Prostate biopsy (either TRUS or MRI Targeted or Template):
Treatments
- Other: questionnaire administration
- Procedure: assessment of therapy complications
- Procedure: high-intensity focused ultrasound ablation
- Procedure: multiparametric magnetic resonance imaging
- Procedure: quality-of-life assessment
- Procedure: transperineal prostate biopsy
- Procedure: transrectal prostate biopsy