High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
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.
|Prostate Cancer||Procedure: high-intensity focused ultrasound ablation||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Feasibility Study for Locally Recurrent Prostate Cancer Treatment With HIFU Using the SONABLATE System|
|Study Start Date:||October 2001|
|Study Completion Date:||December 2008|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030277
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|United States, New York|
|Long Island College Hospital|
|Brooklyn, New York, United States, 11201|
|Study Chair:||Michael O. Koch, MD||Indiana University Melvin and Bren Simon Cancer Center|