MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer
Start Date
4/6/2022
Completion Date
12/7/2028
Summary
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.
Detailed Description
PRIMARY OBJECTIVE: I. To perform the TULSA procedure for safety and efficacy outcomes in men aged 45 to 80 years with biopsy-confirmed, National Comprehensive Cancer Network (NCCN) low to intermediate-risk prostate cancer. SECONDARY OBJECTIVE: I. To assess patient-reported metrics for quality of life (QOL). II. To assess return to normal activity. III. Compare economic benefit as noted from Expanded Prostate Cancer Index Composite (EPIC) questionnaire. OUTLINE: Patients undergo MRI-guided TULSA. Patients may also undergo digital rectal exam (DRE), cystoscopy, biopsy, bone scan, prostate specific membrane antigen (PSMA) positron emission tomography (PET), and/or multiparametric MRI (mpMRI) at screening. After completion of study treatment, patients are followed at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Eligibility Criteria
Age Range: 45 years to 80 years
Interventions
MRI-Guided Transurethral Ultrasound Ablation
Questionnaire Administration
Digital Rectal Examination
Cystoscopy
Biopsy
Bone Scan
PSMA PET Scan
Multiparametric Magnetic Resonance Imaging
Conditions
Locations
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States