Focal Therapy for Prostate Cancer Using HIFU

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.

Trial Details

NCT ID
NCT01194648
Phase
NA
Sponsor
University College, London
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • questionnaire administration
  • assessment of therapy complications
  • high-intensity focused ultrasound ablation
  • multiparametric magnetic resonance imaging
  • quality-of-life assessment
  • transperineal prostate biopsy
Locations (sample)
  • London, England, United Kingdom|51.50853,-0.12574

Key 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:

For full eligibility, visit ClinicalTrials.gov.

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