Trial Summary
What is the purpose of this trial?
A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.
Research Team
Scott E. Eggener
Principal Investigator
University of Chicago
Eligibility Criteria
Men aged 45-80 with localized prostate cancer, a Gleason score ≤3+4, PSA ≤15 ng/ml, and a prostate size within specific MRI measurements. They must be eligible for MRI and general anesthesia, have no major organ issues or severe bladder problems, not on certain medications like hormone therapy recently, and without prior prostate cancer treatments.Inclusion Criteria
My prostate cancer has a Gleason score of 7 or less.
I am a man aged between 45 and 80.
My prostate cancer has a Gleason score of 3+4.
See 11 more
Exclusion Criteria
I have had trouble urinating in the past year.
I have been treated for prostatitis within the last 6 months.
My MRI shows a significantly enlarged median lobe of the prostate.
See 30 more
Treatment Details
Interventions
- MRI-guided Transurethral Ultrasound Ablation (Ultrasound Therapy)
Trial OverviewThe study is testing the safety and effectiveness of TULSA-PRO system which uses ultrasound guided by MRI to target and destroy prostate tissue in patients with localized prostate cancer. It's a single-arm trial involving about 150 men who will all receive this treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: MRI-guided Transurethral Ultrasound Ablation DeviceExperimental Treatment1 Intervention
Magnetic resonance imaging-guided transurethral ultrasound ablation of whole-gland prostate tissue.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Profound Medical Inc.
Lead Sponsor
Trials
4
Recruited
1,400+