NCT05438563Recruiting
MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer
Focal Prostate Ablation for Low to Intermediate Grade Cancer Utilizing TULSA Profound System
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with low to intermediate grade prostate cancer. MRI-guided TULSA ablation is a minimally invasive procedure that uses an ultrasound device guided by MRI imaging to deliver high-energy sound waves, producing very high temperature to ablate (destroy) tumor cells in a targeted manner. The MRI-guided TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 20 May 2022
- Start date
- 6 Apr 2022
- Primary completion date
- 7 Jul 2028
- Lead sponsor
- Mayo Clinic
- Diseases
- Prostate cancer
- NCT number
- NCT05438563
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 6 Apr 2022 to the primary completion date, 7 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Artificial urinary sphincter, penile implant or intraprostatic implant
Other illness
- Unresolved urinary tract infection or prostatitis
- History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
- History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices
Other
- Inability to undergo MRI or general anaesthesia
- Suspected tumour \> 30 mm from the prostatic urethra or \< 14 mm from the prostatic urethra
- Prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor on low-dose pelvic computed tomography (CT)
- Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcification. Imaging for calcification screening must be dated within 1 year of baseline visit
- Less than 10 years life expectancy
- Patients who are otherwise not deemed candidates for radical prostatectomy (RP)
- Inability or unwillingness to provide informed consent
Who the study is looking for
- Male
- Age 45-80 years, with \> 10 years life expectancy
- Biopsy-confirmed, NCCN \[Gleason Grade (GG) 1, favorable GG 2 and unfavorable GG3\] intermediate-risk prostate cancer
- Stage =\< T2c, N0, M0
- International Society of Urological Pathology (ISUP) grade group 1, 2, or 3 disease on transrectal ultrasonography (TRUS)-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy \[minimum 3 cores from each Prostate Imaging-Reporting and Data System (PI-RADS) version (v)2 category \>= 3 lesion\]. Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline
- Prostate specific antigen (PSA) =\< 20 ng/mL reported within 3 months of baseline
- Treatment naive
- Planned ablation volume \< 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline
Age in the registry: 45 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.