The TULSA-PRO® System Featured on the Cover of The Journal of Urology
We are delighted to share that the TULSA-PRO® system was featured on the March 2021 cover of The Journal of Urology
The TULSA-PRO® system delivers precise thermal ablation of a physician prescribed region of prostate tissue, by combining real-time MR imaging, with transurethral directional ultrasound and closed-loop process control software.
One of the most widely read and highly cited journal in the field of urology, The Journal of Urology® is a peer-reviewed journal bringing the most relevant and up-to-date urological learnings and ground-breaking research from premier industry sources. This is the official journal of the American Urological Association (AUA), which Profound Medical is excited to have the TULSA-PRO® system featured in.
Below is the Abstract from The Journal of Urology®
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer
Magnetic resonance imaging-guided transurethral ultrasound ablation uses directional thermal ultrasound under magnetic resonance imaging thermometry feedback control for prostatic ablation. We report 12-month outcomes from a prospective multicenter trial (TACT).
Materials and Methods:
A total of 115 men with favorable to intermediate risk prostate cancer across 13 centers were treated with whole gland ablation sparing the urethra and apical sphincter. The co-primary 12-month endpoints were safety and efficacy.
In all, 72 (63%) had grade group 2 and 77 (67%) had NCCN® intermediate risk disease. Median treatment delivery time was 51 minutes with 98% (IQR 95–99) thermal coverage of target volume and spatial ablation precision of ±1.4 mm on magnetic resonance imaging thermometry. Grade 3 adverse events occurred in 9 (8%) men. The primary endpoint (U.S. Food and Drug Administration mandated) of prostate specific antigen reduction ≥75% was achieved in 110 of 115 (96%) with median prostate specific antigen reduction of 95% and nadir of 0.34 ng/ml. Median prostate volume decreased from 37 to 3 cc. Among 68 men with pretreatment grade group 2 disease, 52 (79%) were free of grade group 2 disease on 12-month biopsy. Of 111 men with 12-month biopsy data, 72 (65%) had no evidence of cancer. Erections (International Index of Erectile Function question 2 score 2 or greater) were maintained/regained in 69 of 92 (75%). Multivariate predictors of persistent grade group 2 at 12 months included intraprostatic calcifications at screening, suboptimal magnetic resonance imaging thermal coverage of target volume and a PI-RADS™ 3 or greater lesion at 12-month magnetic resonance imaging (p <0.05).
The TACT study of magnetic resonance imaging-guided transurethral ultrasound whole gland ablation in men with localized prostate cancer demonstrated effective tissue ablation and prostate specific antigen reduction with low rates of toxicity and residual disease.