ISRCTN69304414
Completed
Phase 2
An evaluation of Focal ablation therapy using High-Intensity Focused Ultrasound in the treatment of localised adenocarcinoma of the prostate
niversity College London Hospitals NHS Foundation Trust (UK)0 sites42 target enrollmentJuly 3, 2008
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- ocalised prostate cancer
- Sponsor
- niversity College London Hospitals NHS Foundation Trust (UK)
- Enrollment
- 42
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Men aged 45 \- 80 years
- •2\. Histological diagnosis of prostate adenocarcinoma
- •3\. Gleason grade total 7 or less (patterns 3\+4 or 4\+3 or less acceptable)
- •4\. Cancer prostate\-confined only (bilateral or unilateral)
- •5\. Serum prostate specific antigen (PSA) less than or equal to 15 ng/mL
- •6\. A life expectancy of 5 years or more
- •7\. Prostate volume less than or equal to 40 cc or maximum anterior\-posterior length less than or equal to 40 mm
- •8\. Has had multi\-sequence magnetic resonance imaging (ms\-MRI) and transperineal template 5 mm spaced biopsies in the 6 months prior to recruitment
- •9\. All malignant areas are treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and at least one neurovascular bundle is preserved
- •10\. Signed informed consent form by patient
Exclusion Criteria
- •1\. Men who have received androgen suppression within previous 6 months
- •2\. Men who have had previous radiation therapy for prostate cancer
- •3\. Men treated with chemotherapy for prostate cancer
- •4\. Men with evidence of metastatic disease
- •5\. Men with latex allergies
- •6\. Men who have undergone prior significant rectal surgery preventing insertion of transrectal probe
- •7\. Men with intraprostatic calcifications making HIFU of focal areas of cancer untreatable
- •8\. Men who have undergone previous transurethral resection of the prostate or laser prostatectomy in the 5 years prior to recruitment
- •9\. Men who have undergone previous HIFU, cryosurgery, thermal or microwave therapy to the prostate at any point prior to recruitment
- •10\. American Society of Anaesthesiology grades III \- IV
Outcomes
Primary Outcomes
Not specified
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