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).