Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer

Official Title

Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study

Summary:

A prospective, multi-centre, single-arm study, planned in 110 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.

Trial Description

Primary Outcome:

• Safety Endpoint - Incidence of treatment-emergent adverse events
• Efficacy Endpoint - Proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.

Secondary Outcome:

• Erectile Dysfunction Endpoint
• Erection Firmness Endpoint
• Urinary Incontinence Endpoint
• PSA Nadir Endpoint
• PSA Stability Endpoint
• Prostate Volume Endpoint
• Prostate Biopsy Endpoint
• IPSS Endpoint
• IIEF Endpoint
• EPIC Endpoint
• Targeting Accuracy Endpoint
• CE-MRI Endpoint
• mpMRI Endpoint

Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system (TULSA-PRO). The technology is developed for patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue. The treatment is conducted within a MRI suite, which enables real-time temperature images of the heated region to be acquired as the ultrasonic treatment is delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the pattern of thermal coagulation accurately and precisely in the prostate gland. It provides advantages of a non-invasive procedure with short treatment times.

View this trial on ClinicalTrials.gov