- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00561314
High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate Cancer
An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the tumor without affecting the surrounding tissue.
PURPOSE: This phase II trial is studying the side effects and how well highly focused ultrasound energy works in treating patients with localized prostate cancer.
Study Overview
Status
Detailed Description
OBJECTIVES:
Primary
- To evaluate feasibility, side effect profile, and patient acceptability of high-intensity focused ultrasound ablation in patients with organ-confined, MRI and histologically proven adenocarcinoma of the prostate.
Secondary
- To determine the effectiveness of therapy via biopsy, MRI, PSA level and estimated time to PSA nadir, and by recording the need for secondary or adjuvant treatment following therapy.
OUTLINE: A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using the Sonablate system is delivered to the prostate tissue over approximately 2 hours. Patients are then evaluated over a 12-month period.
Patients undergo multi-sequence MRI within 10-20 days after HIFU to assess the extent and volume of tumor necrosis and again at 6 months to assess for disease recurrence. Blood is collected for PSA levels at baseline and then at 1, 3, 6, 9, and 12 months. Patients also undergo transrectal ultrasound biopsy at 6 months to evaluate disease response.
Patients complete questionnaires at baseline and at 1, 3, 6, 9, and 12 months to evaluate erectile and sexual function, urinary flow and continence, and quality-of-life.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
England
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Basingstoke, England, United Kingdom, RG24 9NA
- Basingstoke and North Hampshire NHS Foundation Trust
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London, England, United Kingdom, WIT 3AA
- University College of London Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Low-risk disease, as defined by the following criteria:
- Gleason grade total ≤ 7 (patterns 3+4 or 4+3 or less acceptable)
- Localized disease (unilateral or bilateral) (stage T2c, N0, M0 or less)
- Serum PSA ≤ 15 ng/mL
- Prostate volume ≤ 40 cc or maximum anterior-posterior length ≤ 40 mm
- Multi-sequence-MRI and transperineal template 5 mm-spaced biopsies performed within the past 6 months
- All malignant areas must be treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and ≥ 1 neurovascular bundle is preserved
- No intraprostatic calcifications making high-intensity focused ultrasound of focal areas of cancer untreatable
- No metastatic disease
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 5 years
- Must be fit for general or regional anesthesia as assessed by Consultant Anesthetist
- No prior rectal fistula
- No American Society of Anesthesiology grades III-IV
- No latex allergies
- No contraindication to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artifact to images)
- No moderate to severe inflammatory bowel disease
PRIOR CONCURRENT THERAPY:
- No androgen suppression treatment within the past 6 months
- No transurethral resection of the prostate or laser prostatectomy within the past 5 years
- No prior treatment (i.e., radiotherapy, brachytherapy, surgery, laser therapy, chemotherapy, high-intensity focused ultrasound, cryosurgery, thermal therapy, or microwave therapy) for prostate cancer
- No prior significant rectal surgery preventing insertion of transrectal probe
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events
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Patient acceptability, urinary symptoms, and erectile function as assessed by Functional Assessment of Cancer Treatment-Prostate (FACT-P); Item International Index of Erectile Dysfunction (IIEF-15); International Prostate Symptom Score (IPSS); I ...
|
Secondary Outcome Measures
Outcome Measure |
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Effectiveness of high-intensity focal ultrasound ablation to control prostate cancer as determined by time to PSA nadir, MRI at 10-20 days and again at 6 months, biopsies of treated areas at 6 months, and by recording the need for secondary or adjuva ...
|
Collaborators and Investigators
Investigators
- Study Chair: Mark Emberton, MD, FRCS, MBBS, University College London Hospitals
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000574344
- UCLCTC-UCLH-FOCAL-HIFU
- EU-20773
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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