Profound Medical (OTCQX:PRFMF; TSXV:PRN) has completed patient enrollment in the TACT pivotal study designed to further evaluate safety and efficacy of its TULSA-PRO medical device to ablate prostate tissue in patients with localized, organ-confined prostate cancer.
The open-label, single-arm pivotal clinical study has enrolled 110 prostate cancer patients across 13 research sites in the U.S., Canada and Europe. If successful, TACT is expected to support Profound’s application to the FDA for clearance to market the technology in the U.S.
The primary efficacy endpoint of TACT is the proportion of patients achieving a post-treatment prostate-specific antigen (PSA) reduction greater than or equal to 75% of their pre-treatment baseline value. The company’s pre-established performance goal for the success proportion is 50% of patients.
Based on a preliminary analysis of the first 63 evaluable patients, the median PSA reduction to-date is 93%, and 92%, or 58 out of 63, have achieved the PSA reduction success proportion.
The primary safety endpoint is 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.
In a statement, Dr. Scott Eggener, TACT’s principal investigator, said the current 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,” he added.
Arun Menawat, Profound’s CEO, said the company is pleased patient enrollment has now been completed and it looks forward to sharing the full clinical results of this pivotal study with stakeholders in due time.
“We expect data from TACT will help pave the path for the successful commercialization of TULSA-PRO in the U.S. and further drive clinical adoption of the technology in Europe,” he added.