Profound Medical Corp., a Canada-based medical technology company, has reportedly declared topline results from the TULSA-PRO® Ablation Clinical Trial (TACT) pivotal study, which has been carried out to support its application to the U.S. FDA (Food & Drug Administration) for seeking Section 510(k) clearance for marketing TULSA-PRO® all around the US.
As per trusted sources, TACT is an open-label, single-arm, prospective clinical study that required the enrollment of around 115 patients diagnosed with organ-confined, biopsy proven prostate cancer, and executed across thirteen research sites in Canada, Europe and the United States. The key primary and secondary endpoints are established 12 months after treatment and the quality of life as well as disease control will be followed for every protocol up to 5 years. Sources added that the target of the treatment was whole-gland ablation by sparing the urethra & urinary sphincter.
TACT’s primary efficiency endpoint comes out to be a number of patients achieving a 75 percent PSA (Prostate-Specific Antigen) reduction from the pre-treatment baseline value, after the treatment. The secondary endpoints include the prostate volume reduction on a 12-month MRI (Magnetic Resonance Imaging) and histological response on a 12-month, 10-core prostate biopsy.
Dr. Scott Eggener, Director, Prostate Cancer Program, University of Chicago, was quoted saying that patients with organ-confined prostate cancer are being encouraged by the positive results of the TACT study. The study met its primary endpoint of reduction in PSA in about 96 percent of patients having low rates of acute toxicity & residual clinically important GG2 disease. He further believes that a major population of men suffering from prostate cancer are perfectly fit for their treatment with TULSA-PRO®, owing to the positive TACT outcomes and the ability of customizing treatment on the basis of real-time MR images.
Reportedly, the detailed results of the TACT study will be revealed as a late-breaking abstract presentation at the 2019 Annual Meeting Plenary Program of the AUA (American Urological Association) in Chicago.