Feasibility Study for Locally Recurrent Prostate Cancer Treatment With HIFU Using the SONABLATE System
- 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.
Primary Purpose: Treatment
Michael O. Koch, MD
Indiana University Melvin and Bren Simon Cancer Center
United States: Federal Government
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Long Island College Hospital||Brooklyn, New York 11201|