Focal therapy using high-intensity focused ultrasound for prostate cancer
Official title: A Multi-Center Prospective Single Arm Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound (Sonablate 500) for Localized Prostate Cancer
Run by University College, London · NCT01194648 · Data updated 2026-11-12
This study is testing whether high-intensity focused ultrasound can effectively treat localized prostate cancer while causing fewer side effects compared to standard treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 90 Years |
| Sex | Men only |
| Enrollment | 354 (estimated) |
| Sponsor | University College, London Academic / other |
| Locations | 1 site (London, England) |
| Status | Recruiting |
| Started | June 29, 2011 |
| Main results expected | December 2028 |
| Study ends | June 2029 |
| Registry record updated | April 20, 2018 |
| Trial ID | NCT01194648 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men with histologically proven localized prostate cancer who meet specific eligibility criteria regarding disease stage and biopsy results.
✕Probably not a fit
Patients with advanced prostate cancer or those with a life expectancy of less than 10 years may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of high-intensity focused ultrasound (HIFU) for treating localized prostate cancer, aiming to assess its feasibility, safety, and functional outcomes compared to standard care. The study will involve a larger cohort of men to better represent the patient population, addressing the challenges faced by previous randomized controlled trials in this area. Participants will undergo various assessments, including quality-of-life evaluations and monitoring for therapy-related complications. The goal is to determine if HIFU can achieve similar or better outcomes than traditional treatments while minimizing side effects.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for prostate cancer patients, potentially reducing side effects like erectile dysfunction and urinary incontinence.
How similar studies have gone: Previous trials using HIFU have shown promising results, but this study aims to expand on those findings with a larger and more diverse patient population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
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University College London
London, England, United Kingdom Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.