Phase 1 Study: A Prospective, Multi-center, Single Arm Study - Evaluation of the Safety and Feasibility of MRI-guided Transurethral Ultrasound Therapy for the Ablation of Prostate Tissue in Patients With Localized Prostate Cancer
Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral
ultrasound therapy system. The technology is developed for patients with organ confined
prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of
The treatment is conducted completely within an 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, thereby
reducing the risk of possible damage to important surrounding anatomy such as the rectum,
urinary sphincters, neurovascular bundles and pelvic bone. This coagulation method,
therefore, has the potential to have lower complication rates than conventional therapies.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the frequency and severity of device / treatment related adverse events associated with the use of the investigational system to coagulate prostate tissue.
Severity of adverse events per patient will be evaluated and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
12 months from the Treatment Date
Joseph Chin, MD
London Health Science Center
Canada: Health Canada