Focal Laser Ablation of Prostate Tissue

Exclusion Criteria

• •Any significant cancer outside of MRI target (ROI) area, defined as Gleason score \> 3+4
• •* \< 10 years life expectancy
• •* American Society of Anesthesiologists (ASA) criteria of IV or higher
• •* Unfit for conscious sedation anesthesia
• •* Active bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, INR or platelet count (as determined by institutional lab parameters) at the time of screening
• •* Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
• •* Active urinary tract infection
• •* Prostate abscess, chronic or acute prostatitis, or neurogenic bladder
• •* Any prior treatment for prostate cancer
• •* Radical prostatectomy
• •* Radiation therapy (external beam or brachytherapy)
• •* Cryotherapy
• •* High intensity focused ultrasound treatment
• •* Photodynamic therapy
• •* Androgen deprivation therapy
• •* Prior prostate, bladder neck, or urethral stricture surgery
• •* Any prostate debulking procedure, including: transurethral resection of prostate, photovaporization, or electrovaporization
• •* Transurethral incision of bladder neck
• •* Urethral stricture dilation or reconstruction
• •* Any current 5-alpha reductase inhibitors (history of use ≥ 3 months prior to MRI is acceptable)
• •* Prior significant rectal surgery (hemorrhoidectomy is acceptable)
• •* Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
• •* Inflammatory bowel disease
• •* Urinary tract or rectal fistula
• •* Any contraindication to MRI (contrast allergy severe claustrophobia, MRI-incompatible prosthesis)