A Multi-Center Prospective Single Arm Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound (Sonablate 500) for Localized Prostate Cancer
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.
‣ 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