A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU
The proposed study is a prospective, non-randomized concurrently controlled study. The
active treatment arm uses the HIFU procedure with the Sonablate device. The control arm uses
the brachytherapy procedure. The safety and effectiveness of the Sonablate arm will be
compared with the brachytherapy arm. The control arm of the study will be conducted at
clinical sites different from the Sonablate arm.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint will be the absence of biochemical failure, which is defined as a rise of 2.0 ng/mL or more above the PSA nadir and negative biopsy at 24 months.
Mark Schoenberg, M.D.
Johns Hopkins Medical Institution
United States: Food and Drug Administration
|Brachytherapy Site: Urology Centers of Alabama||Birmingham, Alabama 35209|
|Brachytherapy Site: Specialists in Urology||Naples, Florida 34102|
|Brachytherapy Site: Grand Strand Urology||Myrtle Beach, South Carolina 29572|
|HIFU Site: Southeast Urology Network||Memphis, Tennessee 38119|
|HIFU Site: Urology Associates||Nashville, Tennessee 37209|
|HIFU Site: Urology of San Antonio||San Antonio, Texas 78229|