A Study Using Targeted Ultrasound Ablation for Treatment of Localized Prostate
Technical Title: Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients with Localized Prostate Cancer: a Prospective, Single-Ann, Pivotal Clinical Study
Disease Type: Localized prostate cancer
Basic information: 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 endpoint of this technology is thermal coagulation of prostate tissue. The purpose of this study is to obtain information on the safety and effectiveness of the MRI-guided transurethral ultrasound therapy system (TULSA-PRO).
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.
Research Procedures (not a complete list): You will undergo screening to be sure you are a suitable candidate for the study. The screening may include a bone scan, CT scan, MRI, and urology assessment. If you qualify, the TULSA-PRO procedure is performed under general anesthesia. You will have a bladder catheter inserted during the procedure and will keep the catheter in place for at least one week after the procedure. After the procedure, you will return to the clinic 1, 3, and 6 months after your procedure, and annually for 5 years. You will have a follow-up prostate biopsy one year after the procedure. Follow up visits include laboratory tests, MRI scans, and questionnaires.
Eligibility Criteria (not a complete list): Inclusion Criteria:
Exclusion Criteria:
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