High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed adenocarcinoma of the prostate
• •* Low-risk disease, as defined by the following criteria:
• •* Gleason grade total ≤ 7 (patterns 3+4 or 4+3 or less acceptable)
• •* Localized disease (unilateral or bilateral) (stage T2c, N0, M0 or less)
• •* Serum PSA ≤ 15 ng/mL
• •Prostate volume ≤ 40 cc or maximum anterior-posterior length ≤ 40 mm
• •Multi-sequence-MRI and transperineal template 5 mm-spaced biopsies performed within the past 6 months
• •All malignant areas must be treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and ≥ 1 neurovascular bundle is preserved
• •No intraprostatic calcifications making high-intensity focused ultrasound of focal areas of cancer untreatable
• •No metastatic disease
• •PATIENT CHARACTERISTICS:
• •Life expectancy ≥ 5 years
• •Must be fit for general or regional anesthesia as assessed by Consultant Anesthetist
• •No prior rectal fistula
• •No American Society of Anesthesiology grades III-IV
• •No latex allergies
• •No contraindication to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artifact to images)
• •No moderate to severe inflammatory bowel disease
• •PRIOR CONCURRENT THERAPY:
• •No androgen suppression treatment within the past 6 months
• •No transurethral resection of the prostate or laser prostatectomy within the past 5 years
• •No prior treatment (i.e., radiotherapy, brachytherapy, surgery, laser therapy, chemotherapy, high-intensity focused ultrasound, cryosurgery, thermal therapy, or microwave therapy) for prostate cancer
• •No prior significant rectal surgery preventing insertion of transrectal probe