Focal Laser Ablation of Prostate Tissue

Inclusion criteria

• Subjects with untreated organ confined prostate cancer (clinical stage ≤ T2b, Gleason ≤ 3+4)
• Negative metastatic workup with bone scan and CT abdomen/pelvis, within 6 months of study treatment, if indicated by PSA >10
• Age 40 years to 85 years of age
• Multi-parametric MRI at UCLA within 6 months of study treatment, demonstrating a

• Region of interest (ROI) of MRI suspicion level 3 or higher
• MRI-calculated prostate volume 25cc to 100cc
• Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 MRI-ultrasound fusion targeted biopsy cores from above MRI-derived ROI

• Histologically-confirmed adenocarcinoma from targeted biopsy cores
• Overall Gleason score not to exceed 3+4
• Subjects desire focal therapy and decline conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
• Signed informed consent for the FLA treatment through the 12 month follow up visit.

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)