The first patient has been treated in Profound Medical’s (TSX-V:PRN) TACT pivotal trial at Vanderbilt University Medical Center in Nashville, TN.
TACT is a prospective, single-arm pivotal clinical study of 110 patients aimed at further evaluating the safety and efficacy of TULSA-PRO to ablate prostate tissue in patients with localized, organ-confined prostate cancer. Multiple sites in the U.S., Germany, Netherlands, Spain and Canada will participate in the trial.
TULSA-PRO received CE Mark approval in April and is being sold in Europe by Profound’s distribution partners.
TULSA-PRO combines real-time MRI with transurethral, robotically driven therapeutic ultrasound and closed-loop thermal feedback control designed to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects.
In a previous Phase 1 clinical study, TULSA-PRO demonstrated accurate and precise ablation of targeted prostate tissue, while providing a well-tolerated favorable safety profile with minor impact on urinary, erectile and bowel function at 12 months. The results of the study were published in the September 2016 issue of the peer-reviewed journal, European Urology.
“We recognize the potential value that TULSA-PRO provides to the clinical community to address the unmet needs associated with current prostate cancer treatments,” Dr. David Penson, professor and chair, Department of Urologic Surgery, and principal investigator at Vanderbilt University Medical Center, said in a statement.
Arun Menawat, CEO of Profound, said the company believes the TACT study will affirm the results of our Phase 1 trial, “demonstrating that TULSA-PRO is an attractive clinical option for patients with localized prostate cancer.”