Comparing TULSA Procedure and Radical Prostatectomy for Localized Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves men with localized, intermediate risk prostate cancer who will be randomly assigned to receive either the TULSA procedure or radical prostatectomy. The TULSA procedure is a minimally invasive treatment that uses MRI-guided technology to deliver high-energy ultrasound to target and destroy cancerous tissue while preserving surrounding structures important for urinary and sexual function. Participants will be followed for 10 years to assess the effectiveness and safety of the TULSA procedure compared to the traditional surgical approach. The study aims to determine if TULSA can provide similar cancer control with fewer long-term side effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Arizona State Urological Institute
  Chandler, Arizona, United States Recruiting
• East Valley Urological Center
  Mesa, Arizona, United States Recruiting
• Investigate MD
  Scottsdale, Arizona, United States Recruiting
• Atlantic Urology Medical Group
  Long Beach, California, United States Recruiting
• Urology Group of Southern California
  Los Angeles, California, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Gina Clarke
• Email: gclarke@profoundmedical.com
• Phone: 416-689-8156

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.