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
University College, London
354 participants
Jun 29, 2011
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- 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
Interventions
Locations(1)
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NCT01194648