Treatment of Localized Prostate Cancer With High Intensity Focused Ultrasound Using the Sonablate® 500 System in Canada

Inclusion Criteria: * Male patients with an initial presentation of organ confined prostate cancer;(clinical stages T1c and T2a only) * Age 40 yrs. and older up to and including age 80 yrs. * Anesthesia Surgical Assignment (ASA) categories I, II or III only * PSA levels equal tyo or less than 10ng/ml * Pre-HIFU Gleason score equal to or less than 7 * Clearly imageable prostate on TRUS * Prostate total volume less than 40cc with an AP height less than or equal to 4.2cm. (If volume is greater than 40cc or height greater than 4.2 cm, one 3 monthly shot of an LHRH analogue may be provided, followed by re-imaging of the prostate to document total volume below 40cc.) 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).