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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

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 willing to sign a consent form by patient. 7. An understanding of the English language sufficient to understand Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

questionnaire administration

PROCEDURE

assessment of therapy complications

PROCEDURE

high-intensity focused ultrasound ablation

PROCEDURE

multiparametric magnetic resonance imaging

PROCEDURE

quality-of-life assessment

PROCEDURE

transperineal prostate biopsy

PROCEDURE

transrectal prostate biopsy

Locations (1)

University College London
London, England, United Kingdom