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A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer

Prostate Cancer | Prostate Adenocarcinoma

Men with localized, intermediate risk prostate cancer will be randomized to undergo either radical prostatectomy or the TULSA procedure, with a follow-up of 10 years in this multi-centered randomized control trial. This study will determine whether the TULSA procedure is as effective and more safe compared to radical prostatectomy.

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Participation Requirements

  • Sex:

    MALE

  • Eligible Ages:

    40 to 80

Participation Criteria

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

Study Location

Sunnybrook Research Institute
Sunnybrook Research Institute
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Shania Nigli

[email protected]
416-480-6100
Lawson Health Research Institute, London Health Sciences Centre
Lawson Health Research Institute, London Health Sciences Centre
London, Ontario
Canada

Contact Study Team

Study Sponsored By
Profound Medical Inc.
Participants Required
More Information
Study ID: NCT05027477