Pivotal Trial of MRI-guided Transurethral Ultrasound Ablation in Men With Localized Prostate Cancer: Three-year Follow-up.
Journal of Urology
INTRODUCTION AND OBJECTIVE:
MRI-guided transurethral ultrasound ablation (TULSA) is a minimally-invasive procedure for prostate ablation. We report three-year outcomes from the pivotal TULSA-PRO Ablation Clinical Trial (TACT).
The study enrolled 115 men with organ-confined prostate cancer (≤T2b, PSA ≤15 ng/ml, Grade Group 1-2) across 13 centers. Treatment was whole-gland ablation with sparing of the urethra and urinary sphincter. Primary endpoints were safety and PSA reduction at one year. Secondary endpoints included one-year prostate volume reduction, mpMRI, and 10-core biopsy. We report adverse events, quality of life (IPSS, IIEF, EPIC), and PSA for men who are salvage-free and have completed three-year follow-up.
Median (IQR) baseline age was 65 (59-69) years, median PSA 6.3 (4.6-7.9) ng/ml, with Grade Group ≥2 disease in 72/115 men (63%, 69 GG2, 3 GG3). Targeted prostate volumes of 40 (32-50) cc were ablated in 51 (39-66) min, with 98% thermal coverage and ±1.4 mm spatial precision on MRI thermometry. Grade 3 adverse events in 9 (8%) men included GU infection, stricture, retention, urethral calculus and pain, and urinoma, all resolved before one year. There were no rectal injuries or Grade ≥4 events. By three years, 15 men (13%) underwent salvage treatment. At one year MRI and biopsy, median prostate volume decreased from 37 to 3 cc, GG2 disease was eliminated in 54/68 (79%) men, and 72/111 (65%) had no evidence of any cancer. Median PSA decreased 95% to a nadir of 0.26 ng/mL, stable from 0.53 ng/mL at one year to 0.70 ng/ml (n=56) at three years. Median IPSS decreased from 7 at baseline to 4 (n=61) by three years. Moderate urinary incontinence (Grade 2, pads) in three men (2.6%) at one year persisted to three years in one patient (<1%); there was no new incontinence past one year. The rate of moderate erectile dysfunction (Grade 2, responding to medication) was 23% at one year and 24% at three years. Median change in IIEF-5 was -2 from baseline to one year, and zero from one to three years (n=61). In men with three-year follow-up who were potent at baseline, erections sufficient for penetration (IIEF Q2 ≥2) were maintained by 36/50 (72%) and 40/50 (80%) at one and three years.
With three-year follow-up, the TACT pivotal study of MRI-guided transurethral ultrasound ablation (TULSA) in men with localized prostate cancer showed effective disease control with low toxicity and stable quality of life.
Klotz L, Pavlovich CP, Chin J, Hatiboglu G, Koch M, Penson D, et al. Pivotal trial of MRI-guided transurethral ultrasound ablation in men with localized prostate cancer. J Urol. 2021 Sep;206(suppl 3):e814.