Focal Therapy for Prostate Cancer Using HIFU

Summary

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.

Eligibility

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

Conditions5

Browse More Trials