Laser zaps prostate tumors in tiny study

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects with organ-confined prostate cancer (clinical stage ≤ T2b, Gleason =7) * Age 40 to 85 years of age * Multi-parametric MRI read at study site within 9 months of study treatment, demonstrating a Region of interest (ROI) of MRI (PIRADSv2 \> Grade 3)1 * Prostate volume 20cc to 80cc * MRI/ultrasound fusion biopsy with ≥ 10 systematic biopsy cores and ≥ 2 targeted biopsy cores from above MRI-derived ROI within 6 months of study treatment\* * Histologically confirmed adenocarcinoma from targeted biopsy cores * 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) * Treatment plan that allows for treatment of lesion while still maintaining a 4mm safety margin from the rectal wall and urethra * Signed informed consent for the FLA treatment through follow-up per study protocol * For subjects under consideration for repeat FLA, the post-treatment MRI and biopsies done at Months 6 and 12 study visits may be used for these criteria. Exclusion Criteria: * Any significant cancer outside of the intended treatment zone, defined as Gleason score ≥ 7 * \< 10 years life expectancy * Any medical condition that would compromise the subject's ability to safely participate in the study * 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 * Use of aspirin, unless it can be temporarily stopped for a window of at least 14 days prior to FLA procedure * Use of NSAIDS (except aspirin), Vitamin E, multivitamins, and herbal products, unless they can be temporarily stopped for at least 7 days prior to FLA procedure * Active urinary tract infection * Active prostate abscess, prostatitis, or neurogenic bladder * Any prior treatment for prostate cancer, including: * Radical prostatectomy * Radiation therapy (external beam or brachytherapy) * Cryotherapy * High intensity focused ultrasound (HIFU) treatment * Photodynamic therapy * Androgen deprivation therapy * Focal Laser Ablation (acceptable for enrolled subjects under consideration for repeat FLA) * 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 * Use of 5-alpha reductase inhibitors within 6 months of treatment * Prior significant rectal surgery (hemorrhoidectomy is acceptable) * Active rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device * Active inflammatory bowel disease * Urinary tract or rectal fistula * 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)