Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

Study Overview
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Brief Summary
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RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue. PURPOSE: Phase I trial to study the effectiveness of focused ultrasound energy in treating patients who have prostate cancer that has not spread beyond the prostate.

Detailed Description
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OBJECTIVES: Determine the ability of Sonablate to focus ultrasonic waves for the purpose of selectively destroying prostate cancer tissue, with resultant drop in PSA levels to below 0.5 ng/mL and negative biopsy for cancer cells, in patients with organ-confined prostate cancer. OUTLINE: This is a multicenter study. 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 2-3 hours. Patients with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing PSA levels taken at least 2 months apart, visible prostate tissue on ultrasound, and no local or distant metastases after day 90 undergo retreatment with HIFU. Patients are followed at 2, 14, 30, 90, and 180 days. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Official Title
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Feasibility Study for Organ Confined Prostate Cancer Treatment With HIFU Using SONABLATE System

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: high-intensity focused ultrasound ablation


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed organ-confined prostate cancer (clinical stage T1 or T2 only) Pretreatment prostate weight less than 40 g Gleason score no greater than 7 PSA no greater than 10 ng/mL No significant intravesical median lobe (greater than 2 cm) on ultrasound Able to visualize prostate gland adequately on transrectal ultrasound imaging No prostate calcification greater than 5 mm No metastases by bone scan PATIENT CHARACTERISTICS: Age: 40 to 80 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No bleeding disorder as determined by abnormal PT and PTT Renal: No active urinary tract infection No history of urinary bladder neck contracture Other: No prior allergy to latex No Anesthesia Surgical Assignment category IV or greater No interest in future fertility No history of inflammatory bowel disease No other concurrent major debilitating illness No other prior or concurrent malignancy except skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for prostate cancer Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: At least 3 months since prior hormonal therapy (including finasteride) for prostate cancer Radiotherapy: No prior radiotherapy for prostate cancer Surgery: No prior transurethral resection of prostate No prior urethral stent No prior major rectal surgery Other: No prior cryotherapy for prostate cancer No prior thermotherapy No other prior therapy for prostate cancer No concurrent warfarin or other anticoagulant

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- |
|Procedure: high-intensity focused ultrasound ablation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer