High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate

Conditions
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Prostate Cancer, Sexual Dysfunction, Urinary Incontinence

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: biopsy
* Procedure: high-intensity focused ultrasound ablation
* Procedure: magnetic resonance imaging
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|nan|
|Procedure: biopsy|nan|
|Procedure: high-intensity focused ultrasound ablation|nan|
|Procedure: magnetic resonance imaging|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events |  |  | 
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ... |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sexual dysfunction, urinary incontinence, adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer