Profound Medical presents positive initial data from TACT pivotal trial
Profound Medical (TSXV:PRN; OTCQX:PRFMF) presented positive initial data from its TACT pivotal study with its TULSA-PRO ablation device at the American Urological Association (AUA) annual meeting in San Francisco.
The primary efficacy endpoint of TACT is the proportion of patients achieving a post-treatment prostate-specific antigen (PSA) reduction equal to or greater than 75% of their pre-treatment baseline value. The company’s pre-established performance goal for the success proportion is 50% of patients.
In his presentation at AUA, Dr. Laurence Klotz, a world-renowned expert in prostate cancer and investigator in the TACT trial, reported that the median PSA reduction to date is 95% and 95% of patients (109 out of 115) have met the PSA endpoint.
In addition, there was no rectal injury or fistula, no unresolved urinary incontinence greater than Grade 1, and no equal to or greater than Grade 4 adverse events.
Additional secondary endpoints of TACT are 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. Klotz said approximately two-thirds of the prostate cancer patients enrolled in the TACT trial had intermediate-risk disease, a group for whom the current gap between active surveillance and invasive treatments, such as radical prostatectomy and radiation, is often too wide.
“This data, while preliminary, is encouraging and I am very much looking forward to seeing the complete 12-month results,” he added.
Profound CEO, Arun Menawat, said the company was impressed to see the significant reduction in the PSA of patients treated in the TACT pivotal study. “We continue to expect that, once the full results are available, data from TACT will help pave the path for the successful commercialization of TULSA-PRO in the U.S. and help further drive clinical adoption of the technology in Europe.”
TACT is an open-label, single-arm pivotal study. It enrolled 115 patients with biopsy-proven, organ-confined prostate cancer across 13 research sites in the U.S., Canada and Europe.
TULSA-PRO is a minimally invasive, image-guided procedure designed to precisely ablate the prostate with the goal of reducing the risk of side effects commonly associated with other treatments.