Pivotal Study of Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation (TULSA) of the Prostate: 4-Year Follow-Up

Document Type

Conference Proceeding

Publication Date

3-2023

Publication Title

Journal of Vascular and Interventional Radiology

Abstract

Purpose

Magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) of the prostate is a minimally invasive in-bore procedure. The TACT pivotal trial established safety and efficacy at 1 year in patients with low- to intermediate-risk prostate cancer. Here we report 4-year outcomes.

Materials and Methods

115 men with organ-confined PCa (≤T2b, PSA≤15 ng/mL, GG1/GG2) received a single whole-gland TULSA treatment sparing the urethra and urinary sphincter, across 13 sites in 5 countries. Primary endpoints are frequency and severity of adverse events and PSA reduction at 1 year. Secondary endpoints at 1 year are clinical benefit on 10-core biopsy, and mpMRI prostate volume reduction. Follow-up to five years includes quality-of-life, PSA, and adverse events.

Results

At baseline, median (IQR) age and PSA were 65 (59-69) and 6.3 (4.6-7.9) ng/mL. Proportions of men with GG1/GG2/GG3 disease were 15%/60%/3%. Median (IQR) prostate volume was 40 (31-51) cc ablated in 51 (39-66) min. GG2 disease was eliminated in 54/68 (79%) men and 72/111 (65%) had no evidence of disease. Median prostate volume decreased from 37.3 to 2.8 cc (92%). By 4 years, 18 men (16%) received salvage treatment, which was safe and feasible. Median (IQR) PSA reduction was 86% (75%-95%) to 0.9 (0.4-1.6) ng/mL at 4 years (n = 76), and 96% decrease to nadir. Median IPSS decreased from 7 at baseline to 5 at 4 years (n = 73). Erectile function continued to recover, with 69/92 (75%) preserving erections sufficient for penetration (IIEFQ2≥2) at 1 year and 46/57 (81%) at 4 years. Pad-free urinary continence was preserved at 1 and 4 years by 102/111 (92%) and 68/72 (94%), and social continence by 110/111 (99%) and 71/72 (99%). There was no rectal injury or Grade≥4 adverse event. Grade 3 adverse events occurred in 9 men (8%) and included GU infection, retention, pain, urinoma, stricture, and retention, all resolved before 1 year.

Conclusion

Effective disease control and favorable quality of life and safety profile are durable to 4 years after whole-gland ablation with TULSA.

Volume

34

Issue

3S

First Page

S6

Last Page

S7

Comments

Society of Interventional Radiology Annual Scientific Meeting, March 4-9, 2023, Phoenix, AZ.

DOI

10.1016/j.jvir.2022.12.048

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