Profound Medical announced the final results from their TULSA-PRO ablation clinical trial (TACT) in patients with prostate cancer at the annual meeting of the American Urological Association (AUA), which was held May 3-6, 2019, in Chicago. The pivotal study was designed to support Profound’s FDA application to market the device in the United States, and the results show that the study met or surpassed all primary safety and efficacy endpoints.
Key findings included:
- A median prostate-specific antigen (PSA) reduction of 94.9% (nadir 0.34 ng/ml).
- Of 115 patients treated, 110 (95.7%) achieved the PSA reduction endpoint.
- A median perfused prostate volume of patients that decreased from 41 cc to 4 cc.
- A low rate (7%) of serious (Grade 3) adverse events, which all resolved.
- At 12 months, there was 99.1% (111 out of 112) preservation of urinary continence (≤1 pad/day), and a 96.2% rate of leak-free continence (leak <1 time/day).
- At 12 months, only 23.5% of the patients had moderate erectile dysfunction (oral medication indicated), and no patient experienced severe erectile dysfunction (oral medication not helpful).
- Among 68 men with pre-treatment intermediate-risk Gleason Score (GS) 7 disease, 54 (79.4%) were free of GS7 disease on one-year biopsy.
- Of the 111 men with one-year biopsy data, 72 (64.9%) had a complete histological response with no evidence of any cancer, and 16 (14.4%) had low-volume GS6 biologically-insignificant disease.
“We are pleased to announce these positive topline results from TACT contemporaneously with the abstract published online by the AUA,” commented Arun Menawat, Profound’s CEO. Presentation of the full TACT data took place at the AUA annual meeting, and on May 6th 2019 Profound received notification of FDA acceptance of their 510(k) Application Filing for TULSA-PRO®.
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