A Multicenter Clinical Study of the Sonablate®450 for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial)

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 international 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 which would preclude proper suprapubic catheter functioning, per investigator's discretion
• •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 my 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.