Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer
|Prostate Cancer||Device: MR-Guided Transurethral US Ablation of Prostate Tissue||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Evaluate the frequency and severity of device / treatment related adverse events associated with the use of the investigational system to coagulate prostate tissue. [ Time Frame: 12 months from the Treatment Date ]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).
- Evaluate the effectiveness of the investigation system to thermally coagulate prostate tissue conforming to the target volume with a high degree of accuracy and precision. [ Time Frame: 12 months from the Treatment Date ]
• Conformal thermal coagulation of prostate tissue will be determined quantitatively using two measures of targeting accuracy: i. Dice Similarity Coefficient (DSC - unitless from 0 to 1), is a statistical validation metric to measure the degree of spatial overlap between two regions.
ii. Over- and under-targeted volumes (outside the target volume ± ½ voxel margin), representing the amount of tissue ≥ target temperature (55°C) outside the target volume and < target temperature (55°C) inside the target volume, respectively. The over- and under-targeted volumes are expressed as a % of the target volume.
• Coagulation of prostate tissue will be confirmed by measurement of the peripheral region of enhancement surrounding the Non-Perfused Volume (NPV) determined from Contrast-Enhanced MR images (CE-MRI) acquired immediately after treatment and at 12 months after treatment.
- In addition to patient safety and treatment feasibility, initial efficacy of using the investigation system to achieve adequate tumor control for their localized prostate cancer will also be evaluated. [ Time Frame: 12 months from the treatment date ]
- Evaluate the initial effectiveness of the treatment to achieve disease control at 6 months based on biopsy results.
- Characterize the pattern of PSA response in the first 12 months following treatment.
- Evaluate quality of life using the UCLA-PCI-SF & SF-12 v2, IPSS and IIEF standardized questionnaires in the first 12 months following treatment.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||April 2019|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: MR-Guided Transurethral US Ablation
MR-Guided Transurethral US Ablation of Prostate Tissue
Device: MR-Guided Transurethral US Ablation of Prostate Tissue
The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.
Other Name: Prostate Ablation Device: PAD-105
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 prostate tissue.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686958
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|London Health Science Centre|
|London, Ontario, Canada, N6A 5W9|
|German Cancer Research Center (DKFZ)|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Joseph Chin, MD||London Health Science Center|
|Principal Investigator:||James Relle, MD||William Beaumont Hospitals|
|Principal Investigator:||Rayan Berglund, MD||The Cleveland Clinic|
|Principal Investigator:||Heinz P Schlemmer, MD||German Cancer Research Center|