Interventional Oncology
Steven Raman, MD, FSAR, FSIR
Professor of Radiology, Urology and Surgery
David Geffen School of Medicine At UCLA
Disclosure information not submitted.
Sandeep Arora, MD
Associate Professor of Radiology and Biomedical Imaging
Yale School of Medicine
Katarzyna J. Macura, MD, PhD
Professor of Radiology and Radiological Science
The Russell H. Morgan Department of Radiology and
Aytekin Oto, MD, MBA
Professor of Radiology and Surgery
University of Chicago
Jurgen Futterer, MD, PhD
Professor of Image-Guided Oncological Interventions
Radboudumc
Robert Staruch, PhD
Director of Clinical Science
Profound Medical
Temel Tirkes, MD
Associate Professor of Radiology and Imaging Sciences
Indiana University
David Bonekamp, MD, PhD
Professor of Radiology
German Cancer Research Center
Masoom Haider, MD
Principal Investigator
University Health Network
Derek Cool, MD, PhD
Assistant Professor
Schulich School of Medicine
Kiran Nandalur, MD
Vice Chief, Radiology and Molecular Imaging
Beaumont Hospital
Carlos Nicolau, MD
Professor of Radiology
Hospital Clinic de Barcelona
Daniel Costa, MD
Associate Professor of Radiology
University of Texas Southwestern Medical Center
Thorsten Persigehl, MD, PhD
Professor of Radiology
University Hospital Cologne
Gina M. Clarke, Ph.D
Manager, Clinical Science
Profound Medical
Jospeh Chin, MD, FRSC
Professor of Surgery
London Health Sciences Centre
Laurence Klotz, MD, FRSC
Professor of Surgery
Sunnybrook Health Sciences Centre
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.
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.
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