Spots Global Cancer Trial Database for High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer

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Trial Identification

Brief Title: High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer

Official Title: Feasibility Study for Locally Recurrent Prostate Cancer Treatment With HIFU Using the SONABLATE System

Study ID: NCT00030277

Conditions

Prostate Cancer

Interventions

high-intensity focused ultrasound ablation

Study Description

Brief Summary: RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue. PURPOSE: This phase I trial is studying focused ultrasound energy to see how well it works in treating patients with locally recurrent prostate cancer.

Detailed Description: OBJECTIVES: * Determine the ability of Sonablate to focus ultrasound 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 locally recurrent prostate cancer. OUTLINE: Patients are stratified according to prior treatment failure (brachytherapy vs post-external beam radiotherapy). 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 with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing PSA levels taken 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 (10 per stratum) will be accrued for this study.