Steven Raman, MD, FSAR, FSIR
Professor of Radiology, Urology and Surgery
David Geffen School of Medicine At UCLA
Disclosure information not submitted.
Katarzyna J. Macura, MD, PhD
Professor of Radiology and Radiological Science
The Russell H. Morgan Department of Radiology and
Scott Eggener, MD
Professor of Surgery and Radiology
The University of Chicago Medicine & Biological Sc
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.
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.