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Brief Title: MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Intermediate Grade Prostate Cancer
Official Title: Focal Prostate Ablation for Intermediate Grade Cancer Utilizing TULSA Profound System
Study ID: NCT05438563
Brief 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 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) 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.
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Name: David A Woodrum, M.D., Ph.D.
Affiliation: Mayo Clinic in Rochester
Role: PRINCIPAL_INVESTIGATOR