Clinical Trials

Inclusion Criteria:

* Male
* Age 40 to 80 years, with \>10 years life expectancy
* NCCN (favorable and unfavourable) intermediate-risk prostate cancer on biopsy acquired within last 12 months
* Stage ≤cT2c, N0, M0
* ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy or in-bore biopsy
* PSA ≤20ng/mL within last 3 months
* Treatment-naïve
* Planned ablation volume is \< 3 cm axial radius from urethra on mpMRI acquired within last 6 months

Exclusion Criteria:

* Inability to undergo MRI or general anesthesia
* Suspected tumor is \> 30 mm from the prostatic urethra
* Prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor
* 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
* Patients who are otherwise not deemed candidates for radical prostatectomy
* 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/07/2024. Questions regarding updates should be directed to the study team contact.