MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Intermediate Grade Prostate Cancer

Eligibility Criteria

Inclusion Criteria:

* Male
* Age 45-80 years, with > 10 years life expectancy
* Biopsy-confirmed, NCCN [favorable Gleason grade (GG) 2 and unfavorable GG3] intermediate-risk prostate cancer
* Stage =< T2c, N0, M0
* International Society of Urological Pathology (ISUP) grade group 2 or 3 disease on transrectal ultrasonography (TRUS)-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy [minimum 3 cores from each Prostate Imaging-Reporting and Data System (PI-RADS) version (v)2 category >= 3 lesion]. Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline
* Prostate specific antigen (PSA) =< 20 ng/mL reported within 3 months of baseline
* Treatment naive
* Planned ablation volume < 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline

Exclusion Criteria:

* Inability to undergo MRI or general anaesthesia
* Suspected tumour > 30 mm from the prostatic urethra or < 14 mm from the prostatic urethra
* Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumor on low-dose pelvic computed tomography (CT)

* Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcification. Imaging for calcification screening must be dated within 1 year of baseline visit
* Unresolved urinary tract infection or prostatitis
* History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
* Artificial urinary sphincter, penile implant or intraprostatic implant
* Less than 10 years life expectancy
* Patients who are otherwise not deemed candidates for radical prostatectomy (RP)
* Inability or unwillingness to provide informed consent
* History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices