You do not qualify for the study if you have any of the following:
Exclusion Criteria: - American Society of Anesthesiologists(ASA) criteria of IV or higher;
- intra-prostatic calcifications >1.0 cm (single or continuous grouping) on 2 or more consecutive images along the same plane by either the TRUS or Sonablate 500 measurement will not be enrolled;
- active, uncorrected bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, or INR at the time of HIFU (use institutional lab normal ranges for parameters);
- use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped;
- active urinary tract infection;
- interest in future fertility;
- body weight greater than 300lbs;
- inability to visualize the prostatic tissue adequately on transrectal ultrasound imaging;
- use of any 5ARI drugs within 3 months prior to enrollment such as Finasteride (Proscar) or Dutasteride (Avodart);
- a debulking transurethral resection of the prostate (TURP) is not acceptable once the screening biopsy for patient selection has been conducted;
- prior treatment for prostate cancer, other than EBRT or hormone therapy;
- history of urethral stent or urethral surgery (urethral dilation, urethroplasty); a Uroflow exam may be conducted at the investigators discretion;
- prior significant rectal surgery (hemorrhoidectomy is acceptable; rectal resection/fissure repair are excluded);
- history of inflammatory bowel disease of the rectum;
- history of any other malignancy treated within the last 5 years, other than squamous or basal cell skin cancer;
- functional bladder problems defined as IPSS > 19;
- current bladder cancer, urethral stricture, or bladder neck contracture; a cystoscopy may be performed at the investigator’s discretion to rule out these conditions;
- urinary tract or rectal fistula;
- rectal fibrosis/stenosis; anoscopy or proctoscopy may be performed at the investigator’s discretion;
- anomaly of the rectal anatomy or mucus membrane; anoscopy or proctoscopy may be performed at the investigator’s discretion;
- prostate seroma/abscess;
- current symptomatic radiation proctitis requiring creams;
- participation in other investigational studies, unless approved in writing by the study sponsor
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