- Profound Medical confirms durable and stable positive trends following treatment with TULSA-PRO for Men with Localized Prostate Cancer
- The study enrolled 115 patients with biopsy-proven, organ-confined prostate cancer
- TACT demonstrated that the TULSA-PRO provides safe and effective prostate tissue ablation with minimal adverse events
- The primary efficacy endpoint of TACT was PSA reduction at one year, which decreased 95 per cent
- Following treatment with TULSA-PRO, there were no Grade 4 or higher adverse events, no rectal fistula or injury, and no intraprocedural complications
- Profound Medical (PRN) is up 9.12 per cent, trading at C$5.86 at 12:00 pm EST
Profound Medical (PRN) updates results from the TACT pivotal study were presented for the first time this past weekend.
TACT is a single-arm clinical study of whole-gland ablation that enrolled 115 patients with biopsy-proven, organ-confined prostate cancer, with the majority having an intermediate-risk disease.
TACT demonstrated that the TULSA-PRO provides safe and effective prostate tissue ablation with minimal adverse events, significant prostate volume and prostate-specific antigen (PSA) reduction, and low rates of residual prostate disease.
The study was used to support Profound’s application to the U.S. FDA for 510(k) clearance to market TULSA-PRO in the United States, which the Agency granted in August 2019.
The primary efficacy endpoint of TACT was PSA reduction at one year, which decreased 95 per cent to a nadir of 0.34 ng/ml from a median pre-treatment baseline value of 6.3 ng/ml.
By four years, the median PSA nadir was further reduced to 0.28 ng/ml. PSA reduction was durable over the extended follow-up period, from 0.53 ng/ml at one year to 0.86 ng/ml at four years.
The primary safety endpoint of TACT was the frequency and severity of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
Following treatment with TULSA-PRO, there were no Grade 4 or higher adverse events, no rectal fistula or injury, and no intraprocedural complications.
After a four-year follow-up, there were no new devices or treatment-related adverse events.
Secondary oncological endpoints included progression to additional treatment for prostate cancer.
At four years, 16 per cent of TACT patients underwent other prostate cancer interventions.
“As a follow-up to the 12-month outcomes reportemostrnal of Urology, four-year data further demonstrate durable safety profile and patient quality of life outcomes offered by the TULSA-PRO in men with localized prostate cancer,” said Dr. Klotz.
“After four years, erectile and urinary functional outcomes continue to contrast positively with radical prostatectomy and radiation therapy, which can have long-term effects on quality of life,” added Dr. Klotz.”
Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.
Profound Medical (PRN) is up 9.12 per cent, trading at C$5.86 at 12:00 pm EST.
