NCT05438563

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Carcinoma
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	MRI-Guided Transurethral Ultrasound Ablation	Undergo MRI-Guided TULSA
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Digital Rectal Examination	Undergo DRE
PROCEDURE	Cystoscopy	Undergo cystoscopy
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Bone Scan	Undergo bone scan
PROCEDURE	PSMA PET Scan	Undergo PSMA PET
PROCEDURE	Multiparametric Magnetic Resonance Imaging	Undergo mpMRI

Timeline

• Start date: 2022-04-06
• Primary completion: 2027-03-07
• Completion: 2027-03-07
• First posted: 2022-06-30
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States