Status:
RECRUITING
Focal Therapy for Prostate Cancer Using HIFU
Lead Sponsor:
University College, London
Conditions:
Male Erectile Disorder
Prostate Cancer
Eligibility:
MALE
Up to 90 years
Phase:
NA
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 can...
Detailed Description
Verification of a new therapy as favourable, or equivalent, in outcome to 'standard' care is ideally sought through comparison with another matched control group. Randomised controlled trials (RCTs) o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT01194648
Start Date
June 29 2011
End Date
June 1 2029
Last Update
April 20 2018
Active Locations (1)
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1
University College London
London, England, United Kingdom, WC1E 6BT