Klotz, LaurencePavlovich, Christian P.Chin, JosephHatiboglu, GencayKoch, MichaelPenson, DavidRaman, StevenOto, AytekinFütterer, JurgenSerrallach, MarcRelle, JamesLotan, YairHeidenreich, AxelBonekamp, DavidHaider, MasoomTirkes, TemelArora, SandeepMacura, Katarzyna J.Costa, Daniel N.Persigehl, ThorstenPantuck, Allan J.Bomers, JoyceBurtnyk, MathieuStaruch, RobertEggener, Scott2021-06-252021-06-252021-03-01https://hdl.handle.net/2445/178676Purpose: 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. Results: 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). Conclusions: 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.11 p.application/pdfengcc by-nc-nd (c) Klotz et al., 2021http://creativecommons.org/licenses/by-nc-nd/3.0/es/Càncer de pròstataRadioteràpiaProstate cancerRadiotherapyImatges per ressonància magnèticaMagnetic resonance imaginginfo:eu-repo/semantics/article2021-06-25info:eu-repo/semantics/openAccess33021440