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)