NCT01194648 Focal Therapy for Prostate Cancer Using HIFU
| NCT ID | NCT01194648 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College, London |
| Condition | Male Erectile Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 354 participants |
| Start Date | 2011-06-29 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 354 participants in total. It began in 2011-06-29 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Mark Emberton, MD, FRCS, MBBS
STUDY CHAIR
University College, London
Frequently Asked Questions
Who can join the NCT01194648 clinical trial?
This trial is open to male participants only, up to 90 Years, studying Male Erectile Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01194648 currently recruiting?
Yes, NCT01194648 is actively recruiting participants. Visit ClinicalTrials.gov or contact University College, London to inquire about joining.
Where is the NCT01194648 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT01194648 clinical trial?
NCT01194648 is sponsored by University College, London. The principal investigator is Mark Emberton, MD, FRCS, MBBS at University College, London. The trial plans to enroll 354 participants.