CUIMC Focal Therapy Registry

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)