Actively Recruiting
Focal Therapy for Prostate Cancer Using HIFU
Led by University College, London · Updated on 2018-04-20
354
Participants Needed
1
Research Sites
935 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Focal Therapy for Prostate Cancer Using HIFU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate cancer on transrectal or transperineal biopsy
- Prostate biopsy showing unilateral or limited bilateral disease with specific Gleason scores as detailed in the protocol
- Stage T1 to T2cN0M0 prostate cancer, with radiological T3a permitted
- Serum PSA level less than or equal to 20 ng/ml
- Life expectancy of 10 years or more
- Signed informed consent
- Ability to understand English sufficiently to participate
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University College London
London, England, United Kingdom, WC1E 6BT
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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