MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45-80
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- MRI-Guided Transurethral Ultrasound Ablation
- Questionnaire Administration
- Digital Rectal Examination
- Cystoscopy
- Biopsy
- Bone Scan
- PSMA PET Scan
- Multiparametric Magnetic Resonance Imaging
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov