NCT02766543

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Profound Medical Inc. · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multi-center, single-arm study, planned in 150 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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	MRI-guided Transurethral Ultrasound Ablation	Magnetic resonance imaging-guided transurethral ultrasound ablation is a novel minimally-invasive procedure where the therapeutic endpoint is prostate ablation through thermal coagulation.

Timeline

• Start date: 2016-09-21
• Primary completion: 2019-02-28
• Completion: 2028-09-30
• First posted: 2016-05-09
• Last updated: 2025-08-17

Locations

14 sites across 5 countries: United States, Canada, Germany, Netherlands, Spain