Focal Therapy for Prostate Cancer Using HIFU
Recruiting · NCT01194648 · Interventional (participants receive a specific treatment) · Lead sponsor: University College, London
View the official record on ClinicalTrials.gov →Interventions studied
assessment of therapy complicationshigh-intensity focused ultrasound ablationmultiparametric magnetic resonance imagingquality-of-life assessmentquestionnaire administrationtransperineal prostate biopsytransrectal prostate biopsy
What this trial is about
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.
Who can take part
Age range
Up to 90 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (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
Where it is running
1 location listed.
- University College London - London, England, United Kingdom