New registry to track prostate cancer focal therapy results

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

Inclusion Criteria: * Organ-confined prostate adenocarcinoma diagnosed by MRI/ultrasound fusion biopsy within a multiparametric MRI derived region of interest * Clinical stage T2cN0M0 (radiological T3a is permitted) * Multi-parametric MRI at New York-Presbyterian hospital (NYPH) within the past 6 months demonstrating region of interest suspicion level 2 by the Prostate Imaging Reporting and Data System version 2.0 scoring criteria * Transrectal or transperineal ultrasound-guided biopsy with 10 template biopsy cores and 2 MRI-ultrasound fusion targeted biopsy cores from the above MRI-derived region of interest demonstrating: 1. histologically confirmed prostate adenocarcinoma from targeted biopsy cores 2. unilateral Gleason score 4+3 prostate adenocarcinoma * Age 40 to 85 years of age * Subjects choose to undergo focal therapy and decline alternative treatment (such as active surveillance, radical prostatectomy, radiation therapy, cryosurgery or hormone therapy) * Signed informed consent Exclusion Criteria: * Any Gleason score 4+4 outside an MRI-identified region of interest * Prostatic calcifications which in the opinion of the investigator would impede delivery of the energy to tumor in patients choosing HIFU * Any medical condition that would compromise the subject's ability to safely participate in the study * American Society of Anesthesiologists (ASA) criteria of IV or higher * Active urinary tract infection * Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device * Active, uncontrolled inflammatory bowel disease * Urinary tract or rectal fistula * Previous urethral sling, artificial urinary sphincter, or penile prosthesis surgery * Any contraindication to MRI (such as contrast allergy, sever claustrophobia, MRI-incompatible prosthesis)