Phase 1 Study: A Prospective, Multi-center, Single Arm Study - Evaluation of the Safety and Feasibility of MRI-guided Transurethral Ultrasound Therapy for the Ablation of Prostate Tissue in Patients With Localized Prostate Cancer

Fecha de inicio: 13 de marzo de 2013

Inclusion Criteria: Male, age ≥65 Patient with low-risk, early-stage organ-confined prostate cancer (Stage T1c or T2a, N0, M0). Gleason score 6 (3+3) Prostate-specific antigen (PSA) ≤ 10 ng/ml Eligible for MR imaging (DOC-10252) Meets the following criteria on pre-treatment transrectal ultrasound imaging: No cysts or calcifications > 1.0 cm in size No evidence of extraprostatic extension or seminal vesicle invasion Overall prostate size less than 5 cm in sagittal length and less than 7 cm in diameter Biopsy confirmed adenocarcinoma of the prostate, performed at least 6 weeks prior to and no more than 6 months prior to the scheduled treatment. Eligible for General Anesthesia, as defined in American Society of Anesthesiologists (ASA) Normal rectal anatomy and rectal mucosa on digital rectal examination Exclusion Criteria: Bleeding disorder Abnormal coagulation and current anticoagulant therapy. Acute or chronic Urinary Tract Infection Interest in future fertility History of allergy relevant medication or other History of any other malignancy other than skin cancer Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome Prior treatment of the prostate gland Prior treatment with 5 alpha reductase inhibitor allowed (not as prostate cancer treatment or prevention) as long as drug has been stopped for minimum 3 months History of any major rectal or pelvic surgery History of ulcerative colitis or other chronic inflammatory conditions affecting rectum History of documented clinical prostatitis requiring therapy within previous 6 months History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae which had required prior urethrotomy, urethral stenting, urethroplasty or chronic indwelling urethral catheter Patients with artificial urinary sphincter or any penile implant (metallic or non-metallic) Neurologic bladder disorders Untreated bladder stones History of acute urinary retention Confirmed or suspected bladder cancer Urinary sphincter abnormalities Active untreated gross hematuria for any cause Post Void Residual (PVR) bladder volume > 250 mL Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder Additional exclusion criteria on file....