Profound Medical Enrolls Last Patients in Phase 2 Trial of Minimally Invasive Ablation Method

Profound Medical Enrolls Last Patients in Phase 2 Trial of Minimally Invasive Ablation Method
The pivotal Phase 2 trial evaluating TULSA-PRO system, a minimally invasive procedure that ablates prostate cancer tissue, has enrolled 87 percent of all estimated participants, Profound Medical announced. The TACT study has already tested the system in 96 men with localized, organ-confined prostate cancer. Arun Menawat, CEO of the Toronto-based company, said in a press release that it expects to complete enrollment in February, with the addition of 14 new patients. TULSA-PRO offers men an alternative treatment option for the resection of localized and organ-confined prostate cancer tissue. The system combines real-time magnetic resonance imaging (MRI) with robotically driven ultrasound thermal energy, delivered through the urethra. This kills prostate cancer cells with high precision using thermal energy. But a tight thermal feedback control also ensures that no critical surrounding tissues are harmed during the procedure. Besides being non-invasive, treatment is also faster, with the single-session procedure lasting less than 40 minutes. In a prior Phase 1 trial (NCT01686958) of 30 prostate cancer patients, TULSA-PRO was found to be safe and well tolerated, with minor impact on urinary, erectile and bowel function one year after treatment. The findings, published September 2016 in European Urolog
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