Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer

Inclusion Criteria: * T1c or T2a carcinoma of the prostate confirmed by biopsy; * life expectancy of 5(five) years or more; * prostate biopsy with 10(ten) or more core biopsies; * Gleason score of 6(six) or less; * serum Prostate Specific Antigen (PSA) of 10(ten)ng/ml or less; * prostate volume of less than 40(Forty)cc; * distance from the Anterior capsule surface to the Posterior capsule surface (AP Diameter) of 40(Forty)cm or less; * informed consent for the treatment study through 24 months post-treatment follow-up Exclusion Criteria: * men who have had previous definitive treatment for prostate cancer; * evidence of metastatic disease and/or a previous positive bone-scan, previous diagnosis or treatment for cancer within the last 5(five) years; * prior hormonal therapy for prostate cancer (including bilateral orchiectomy); * inability to tolerate a transrectal ultrasound; * active urinary tract infection; * functional bladder problems; * prior significant rectal surgery; * intra-prostatic calcifications greater than 1(One)cm in diameter; * interest in future fertility; * prostatic surgery/procedure (except biopsy) within 1(One) year; * large median lobe of the prostate; * use of medications that can affect PSA within 2(Two) months (e.g. finasteride, saw palmetto); * current bladder cancer, urethral stricture, or bladder neck contracture; * urinary tract and/or rectal fistula; * rectal fibrosis/stenosis; * anomaly of the rectal anatomy or mucus membrane; * prostate seroma/abcess; * prostatitis; * compromised renal function or upper urinary tract disease secondary to urinary obstruction; * bleeding disorders/coagulopathy based on measures of PT and PTT; * implant in the prostate or within 1(One)cm of the prostate; * zip code of the primary residence of the subject is greater than 200(Two hundred) miles from the clinical site or transportation that would hinder the completion of the study