Globe Newswire02.26.18
Profound Medical Corp., developer of a therapeutic platform that provides the precision of real-time MR imaging combined with the safety and accuracy of directional (inside-out) and focused (outside-in) ultrasound technology for incision-free ablation of diseased tissue, has completed patient enrollment in the TACT (TULSA-PRO Ablation Clinical Trial) pivotal study designed to further evaluate the safety and efficacy of TULSA-PRO to ablate prostate tissue in patients with localized, organ-confined prostate cancer.
TACT, a prospective, open-label, single-arm pivotal clinical study, has enrolled 110 prostate cancer patients across 13 research sites in the United States, Canada and Europe. If successful, TACT is expected to support Profound’s application to the U.S. Food and Drug Administration (FDA) for clearance to market this technology in the United States.
The primary efficacy endpoint of TACT is the proportion of patients achieving a post-treatment prostate-specific antigen (“PSA”) reduction greater or equal to 75 percent of their pre-treatment baseline value. The company’s pre-established performance goal for the success proportion is 50 percent of patients. Based on a preliminary analysis performed by the company, of the first 63 evaluable patients, the median PSA reduction to-date is 93 percent, and 92 percent (58 out of 63) have achieved the PSA reduction success proportion.
The primary safety endpoint is the frequency and severity of adverse events, with additional secondary endpoints focused on quality-of-life side effects commonly associated with current prostate cancer therapies, such as erectile dysfunction and urinary incontinence. As the standard evaluation period for these side effects is 12 months post-treatment, the sample size of evaluable patients is not yet large enough to assess.
“It is very exciting the TACT trial has completed accrual in such a timely manner,” said Dr. Scott Eggener, TACT’s principal investigator; professor of Surgery and Radiology, and director of the Prostate Cancer Program at the University of Chicago (Ill.). “Today, the gap between active surveillance and radical treatments such as surgery and radiation is often too wide for both clinicians and patients. TULSA-PRO is a minimally-invasive and image-guided option intending to ablate low and intermediate risk prostate cancers with the goal of reducing the risk of side-effects commonly associated with other treatments. There has been a smooth collaboration between the various clinical sites and Profound and we all are looking forward to seeing the final results.”
“We are pleased patient enrollment has now been completed and look forward to sharing the full clinical results of this pivotal study with our stakeholders in due time,” commented Arun Menawat, Profound’s CEO. “We expect data from TACT will help pave the path for the successful commercialization of TULSA-PRO in the United States and further drive clinical adoption of the technology in Europe.”
Profound Medical is committed to creating the combination of real-time magnetic resoning guidance as the imaging platform and ultrasound as the energy source for delivering non-invasive ablative tools to clinicians. These key technology pillars, linked with intelligent software and robotics, have the potential to fulfill unmet needs of patients and clinicians in many anatomies and disease states, including prostate cancer, uterine fibroids, and bone metastases. Our mission is to profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives.
Profound Medical is commercializing a technology, TULSA-PRO, which combines real-time magnetic resonance (MR) imaging with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control that is designed to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects. TULSA-PRO is CE marked and Profound Medical is currently conducting a pilot commercial launch of the technology in key European and other CE mark jurisdictions. The company is also sponsoring a multicenter, prospective FDA-registered clinical trial, TACT, which, if successful, is expected to support its application to the FDA for clearance to market TULSA-PRO in the United States.
Profound Medical is also commercializing Sonalleve, an innovative therapeutic platform that combines real-time MR imaging and thermometry with thermal ultrasound to enable precise and incision-free ablation of diseased tissue. Sonalleve is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. The company is also in the early stages of exploring additional potential treatment markets for Sonalleve, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy, where the technology has been shown to have clinical application.
TACT, a prospective, open-label, single-arm pivotal clinical study, has enrolled 110 prostate cancer patients across 13 research sites in the United States, Canada and Europe. If successful, TACT is expected to support Profound’s application to the U.S. Food and Drug Administration (FDA) for clearance to market this technology in the United States.
The primary efficacy endpoint of TACT is the proportion of patients achieving a post-treatment prostate-specific antigen (“PSA”) reduction greater or equal to 75 percent of their pre-treatment baseline value. The company’s pre-established performance goal for the success proportion is 50 percent of patients. Based on a preliminary analysis performed by the company, of the first 63 evaluable patients, the median PSA reduction to-date is 93 percent, and 92 percent (58 out of 63) have achieved the PSA reduction success proportion.
The primary safety endpoint is the frequency and severity of adverse events, with additional secondary endpoints focused on quality-of-life side effects commonly associated with current prostate cancer therapies, such as erectile dysfunction and urinary incontinence. As the standard evaluation period for these side effects is 12 months post-treatment, the sample size of evaluable patients is not yet large enough to assess.
“It is very exciting the TACT trial has completed accrual in such a timely manner,” said Dr. Scott Eggener, TACT’s principal investigator; professor of Surgery and Radiology, and director of the Prostate Cancer Program at the University of Chicago (Ill.). “Today, the gap between active surveillance and radical treatments such as surgery and radiation is often too wide for both clinicians and patients. TULSA-PRO is a minimally-invasive and image-guided option intending to ablate low and intermediate risk prostate cancers with the goal of reducing the risk of side-effects commonly associated with other treatments. There has been a smooth collaboration between the various clinical sites and Profound and we all are looking forward to seeing the final results.”
“We are pleased patient enrollment has now been completed and look forward to sharing the full clinical results of this pivotal study with our stakeholders in due time,” commented Arun Menawat, Profound’s CEO. “We expect data from TACT will help pave the path for the successful commercialization of TULSA-PRO in the United States and further drive clinical adoption of the technology in Europe.”
Profound Medical is committed to creating the combination of real-time magnetic resoning guidance as the imaging platform and ultrasound as the energy source for delivering non-invasive ablative tools to clinicians. These key technology pillars, linked with intelligent software and robotics, have the potential to fulfill unmet needs of patients and clinicians in many anatomies and disease states, including prostate cancer, uterine fibroids, and bone metastases. Our mission is to profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives.
Profound Medical is commercializing a technology, TULSA-PRO, which combines real-time magnetic resonance (MR) imaging with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control that is designed to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects. TULSA-PRO is CE marked and Profound Medical is currently conducting a pilot commercial launch of the technology in key European and other CE mark jurisdictions. The company is also sponsoring a multicenter, prospective FDA-registered clinical trial, TACT, which, if successful, is expected to support its application to the FDA for clearance to market TULSA-PRO in the United States.
Profound Medical is also commercializing Sonalleve, an innovative therapeutic platform that combines real-time MR imaging and thermometry with thermal ultrasound to enable precise and incision-free ablation of diseased tissue. Sonalleve is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. The company is also in the early stages of exploring additional potential treatment markets for Sonalleve, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy, where the technology has been shown to have clinical application.
