MRI-guided transurethral ultrasound ablation (TULSA) uses directional thermal ultrasound under MRI thermometry feedback control for prostatic ablation. We report 12-month outcomes from a prospective multicenter trial (TACT).
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.
72 (63%) had GG2 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 MRI thermometry. Grade 3 adverse events occurred in 9 (8%) men. The primary endpoint (FDA mandated) of PSA reduction ≥75% was achieved in 110 of 115 (96%) with median PSA reduction of 95% and nadir of 0.34 ng/ml. Median prostate volume decreased from 37 to 3 cc. Among 68 men with pre-treatment GG2, 52 (79%) were free of GG2 disease on 12-month biopsy. Of 111 men with 12-month biopsy data, 72 (65%) had no evidence of cancer. Erections (IIEF Q2 ≥ 2) were maintained/regained in 69 of 92 (75%). Multivariate predictors of persistent GG2 at 12 months included intra-prostatic calcifications at screening, suboptimal MRI thermal coverage of target volume, and a PIRADS ≥ 3 lesion at 12-month MRI (p < 0.05).
The TACT study of MRI-guided transurethral ultrasound whole-gland ablation in men with localized prostate cancer demonstrated effective tissue ablation and PSA reduction with low rates of toxicity and residual disease.
The Journal of urology. 2020 Oct 06 [Epub ahead of print]
Laurence Klotz, Christian P Pavlovich, Joseph Chin, Gencay Hatiboglu, Michael Koch, David Penson, Steven Raman, Aytekin Oto, Jurgen Fütterer, Marc Serrallach, James Relle, Yair Lotan, Axel Heidenreich, David Bonekamp, Masoom Haider, Temel Tirkes, Sandeep Arora, Katarzyna J Macura, Daniel N Costa, Thorsten Persigehl, Allan J Pantuck, Joyce Bomers, Mathieu Burtnyk, Robert Staruch, Scott Eggener