Clinical Research Directory

Inclusion Criteria: * Subjects with untreated, organ-confined prostate cancer (clinical stage ≤ T2b, Gleason =7) x Age 40 to 85 years of age * Multi-parametric MRI at University of California at Los Angeles (UCLA) within 6 months of study treatment, demonstrating a Region of interest (ROI) of MRI (PIRADSv2 \> Grade 3). x Prostate volume 20cc to 80cc * Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 targeted biopsy cores from above MRI-derived ROI within 6 month of biopsy results * Histologically-confirmed adenocarcinoma from targeted biopsy cores x Overall Gleason = 3+4 or 4+3 * 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 Exclusion Criteria: * Any significant cancer outside of the intended treatment zone, defined as Gleason score 7 x \< 10 years life expectancy * Any medical condition that would compromise the subject's ability to safely ● Active bleeding disorder * 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 x Active prostate abscess, prostatitis, or neurogenic bladder x Any prior treatment for prostate cancer, including: * Radical prostatectomy * Radiation therapy (external beam or brachytherapy) * Cryotherapy * High intensity focused ultrasound (HIFU) treatment o Photodynamic therapy o 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 x Urethral stricture dilation or reconstruction * Use of 5-alpha reductase inhibitors within 6 months of treatment x Prior significant rectal surgery (hemorrhoidectomy is acceptable) * Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device * Inflammatory bowel disease x Urinary tract or rectal fistula x Previous urethral sling, artificial urinary sphincter or penile prosthesis surgery. * Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible prosthesis, MRI-unsafe aneurysm clips)