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

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

Male

Healthy Volunteers

No

Minimum Age

40 Years

Maximum Age

80 Years

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