Investigational Study For the Treatment of Localized (T1c/T2a) Prostate Cancer With High Intensity Focused Ultrasound (HIFU) Using the Sonablate 500 (SB-500) System in Canada

Exclusion Criteria

• •Large calcification in the area to be treated (\>5mm);
• •Bleeding disorder as determined by abnormal prothrombin time (INR) and partial thromboplastin time (PTT);
• •Pt. on Coumadin or any other anticoagulent, unless their anticoagulation an be temporarily reversed or stopped;
• •Urinary Tract infection unless treated satisfactorily by antibiotics and documented by a sterile urine culture;
• •Interest in future fertility;
• •History of allergy to latex;
• •Inability to visualize the prostate tissue adequately on transrectal ultrasound imaging;
• •History of treatment for prostate cancer (except for one LHRH analogue "shrinkage shot");
• •History of TURP, thermotherapy or urethral stent;
• •History of any major rectal surgery;
• •History of inflammatory bowel disease;
• •History of urinary bladder neck contracture;
• •History of any other malignancy other than skin cancer. Patients that have had a previous malignancy and no recurrence of that malignancy within the past 5 years will be allowed; (superficial bladder cancer is OK of clear for 2 years)
• •Inability to be placed in lithotomy position;
• •Prior long term hormonal therapy for prostate cancer (including bilateral orchiectomy).