The proposed study is a non-randomized, prospective, single arm study. The safety and effectiveness of the Sonablate 500 treatment in subjects with locally recurrent prostate cancer will be evaluated with regard to freedom from biochemical failure and disease recurrence following HIFU treatment.

Men with histologically confirmed, locally recurrent, organ-confined, non-metastatic prostatic adenocarcinoma two or more years following EBRT, PSA ≥0.5 ng/mL and ≤10 ng/mL, 40 to 85 years of age, and with initial staging of T1c or T2 prior to radiation who meet the criteria for salvage treatment, will be enrolled.

Indication: For the treatment of locally recurrent prostate cancer following failed external beam radiation therapy (EBRT).

Study Design: The proposed study is a non-randomized, prospective, single arm study. The safety and effectiveness of the Sonablate 500 treatment in subjects with locally recurrent prostate cancer will be evaluated with regard to freedom from biochemical failure and disease recurrence following HIFU treatment.

Population: Men with histologically confirmed, locally recurrent, organ confined, non-metastatic prostatic adenocarcinoma two or more years following EBRT, PSA ≥0.5 ng/mL and ≤10 ng/mL, 40 to 85 years of age, and with initial staging of T1c or T2 prior to radiation, who meet the criteria for salvage treatment will be enrolled.

Duration of Study: This pivotal study will cover pre-treatment through the 12-month post-treatment follow-up visit (7 visits total).   A 5-year extended follow-up study will be conducted annually for the second through fifth year post-treatment (4 additional visits). 

Sponsor
Focus Surgery, Inc. 
3940 Pendleton Way 
Indianapolis, IN 46226 
Phone: (317) 541-1580 
Fax: (317) 541-1581

US HIFU, LLC
801 E. Morehead St.
Suite 201
Charlotte, NC 28202
Phone: 1 (877) 874-4384
Fax: (704) 817-1161 

Sponsor Contact
Adam Lowe
Vice President of Scientific Affairs & Device Operations
US HIFU Clinical Operations
801 E. Morehead St.
Suite 201
Charlotte, NC 28202 
Office: (704) 817-1165
Fax: (704) 817-1161

Medical Monitor:
Herbert Lepor, M.D. Professor and Martin Spatz Chairman
NYU Medical Center Department of Urology
150 East 32nd Street
2nd Floor
New York, NY 10016
Phone: (646) 825-6327