Vanderbilt University Medical Center is the world’s first site to treat a patient in the TULSA-PRO Ablation Clinical Trial (TACT), which employs an emerging therapy that uses MRI guidance and robotically driven therapeutic ultrasound to obtain precise prostate cancer tissue ablation.
Investigators, David Penson, M.D., MPH, professor and chair of Urologic Surgery, and Sandeep Arora, MBBS, assistant professor of Radiology and Radiological Sciences, treated the first patient Wednesday in Nashville, Tennessee.
Multiple sites throughout the United States, Germany, Netherlands, Spain and Canada will also be participating in TACT, a prospective, single-arm pivotal clinical study of 110 patients to further evaluate the safety and efficacy of TULSA-PRO.
Penson said the Vanderbilt research is a joint effort between Urology, Radiology and the Vanderbilt University Institute of Imaging Science (VUIIS).
“Enrolling the first patient in this trial is truly exciting for our institution. We recognize the potential value that TULSA provides to the clinical community to address the unmet needs associated with current prostate cancer treatments,” Penson said. “We are pleased to collaborate with the other clinical trial sites in the effort to advance this promising therapy.”
Prostate cancer is the second most common cancer among men, and patients often experience side effects such as erectile dysfunction, urinary incontinence and bowel complications.
The results of a previous Phase 1 clinical study for TULSA-PRO, published in the September 2016 issue of European Urology, showed accurate ablation of targeted prostate tissue with minor impact on urinary, erectile and bowel function at 12 months.
“The enrollment of the first patient in the TACT pivotal study is another important milestone for our Company,” Profound Medical Corp. Chief Executive Officer Arun Menawat said.
“We believe this study will affirm the results of our Phase l trial, demonstrating that TULSA is an attractive clinical option for patients with localized prostate cancer.”
