MRI-guided transurethral ultrasound prostate ablation: midterm outcomes of a phase I clinical trial

Abstract

Background/introduction: MRI-guided transurethral ultrasound ablation (TULSA) is a new minimally-invasive modality for the treatment of prostate cancer, which aims to provide local disease control with low morbidity. A transurethral ultrasound device generates a continuous volume of thermal coagulation that is shaped precisely to the prostate using real-time MR thermometry and active temperature feedback control. The aim of this multi-center, prospective Phase I clinical study is to determine the safety and feasibility of MRI-guided TULSA, and to assess initial efficacy for treatment of localized prostate cancer. Methods: A total of 30 patients were enrolled with biopsy-proven, low-risk, localized prostate cancer: age >= 65 years, clinical stage T1c/T2a, PSA