NCT01194648Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Apr 2018 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 354 (estimated)
- First submitted
- 2 Sept 2010
- Start date
- 29 Jun 2011
- Primary completion date
- Dec 2028
- Lead sponsor
- University College, London
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT01194648
What you commit to
- Study type: Interventional
- Planned participants: 354
- From 29 Jun 2011 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: - to 90 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.