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Focal Therapy for Prostate Cancer Using HIFU

RecruitingNAAges any - 90 YearsMaleUniversity College, London
NCT01194648 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • questionnaire administration
  • assessment of therapy complications
  • high-intensity focused ultrasound ablation
  • multiparametric magnetic resonance imaging
  • quality-of-life assessment
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Where

1 site
University College London
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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