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Focal Therapy for Prostate Cancer Using HIFU

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About this study

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.

Condition
Male Erectile Disorder, Prostate Cancer, Therapy-related Toxicity, Urinary Incontinence
Tested
questionnaire administration, assessment of therapy complications, high-intensity focused ultrasound ablation, multipara...
Sponsor
University College, London

Who can join

Age
Up to 90 years
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 14

  • Maximum age: 90 years
  • Eligible sex: Male
  • Study condition: Male Erectile Disorder, Prostate Cancer, Therapy-related Toxicity, Urinary Incontinence
  • 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

Where

1 site, 1 recruiting

University College London

London, England, United Kingdom

Recruiting

Potential match only. Final eligibility is determined by the study team.