SIR 2024
Interventional Oncology
Steven Raman, MD, FSAR, FSIR
Professor of Radiology, Urology and Surgery
David Geffen School of Medicine At UCLA
Financial relationships: Full list of relationships is listed on the CME information page.
Sandeep Arora, MD
Associate Professor of Radiology and Biomedical Imaging
Yale School of Medicine
Disclosure information not submitted.
Katarzyna J. Macura, MD, PhD
Professor of Radiology and Radiological Science
The Russell H. Morgan Department of Radiology and
Disclosure information not submitted.
Aytekin Oto, MD, MBA
Professor of Radiology and Surgery
University of Chicago
Disclosure information not submitted.
Jurgen Futterer, MD, PhD
Professor of Image-Guided Oncological Interventions
Radboudumc, Netherlands
Disclosure information not submitted.
Temel Tirkes, MD
Associate Professor of Radiology and Imaging Sciences
Indiana University
Disclosure information not submitted.
Daniel Costa, MD
Associate Professor of Radiology
University of Texas Southwestern Medical Center
Disclosure information not submitted.
In-bore MRI-guided transurethral ultrasound ablation (TULSA) sonographically coagulates prostate tissue within focal or whole-gland ablation plans, while automatically adjusting treatment parameters based on real-time MRI thermometry feedback. The TACT pivotal study demonstrated favorable safety and efficacy at 1 year in men with localized, predominantly intermediate-risk prostate cancer (PCa). Here we report the 5-safety, quality of life, and oncological outcomes at 5 year follow-up.
Materials and Methods: 115 men were enrolled across 13 sites in 5 countries, with GG 2 and 1 PCa, stage ≤ T2b, and PSA ≤ 15 ng/mL. Men received a single whole-gland TULSA treatment sparing the prostatic urethra and urinary sphincter. Multiparametric MRI and 10-core biopsy assessed prostate volume reduction and histologic control at one year. Adverse events, continence, erectile function (SHIM), urinary symptoms (IPSS), and the rate of salvage treatment were assessed to five years.
Results: GG≥2 PCa was present in 72/115 (63%) at baseline and 17/111 (15%) at 1y. Median (IQR) PSA decreased from 6.3 (4.6-7.9) ng/ml to 0.26 (0.1-0.5) ng/ml nadir, durable to 0.63 (0.18-1.9) ng/mL at 5y (n=68). Median prostate volume decreased 92% from 37.3 to 2.8 ml at 1 year. By 5y, 25 men (21.7%) received salvage treatment, all without unexpected complications (10 prostatectomy, 11 radiotherapy, 3 radiation plus ADT, 1 surgery plus radiation). Early predictors of treatment failure included 1y PSA (OR=3; CI [1.7,5.4]) and mpMRI (OR=12; CI[4.4,34]), both p≤0.001. Failure analysis identified preventable errors in patient selection, calcification size and location, targeting, or misalignment due to intraprocedural swelling/motion. By 5y, 92% (61/66) recovered pad-free continence, 87% (80/92) preserved erections sufficient for penetration, and median (IQR) IPSS urinary symptom score was stable from 7 (3-10) to 4 (3-12). Grade 3 adverse events occurred in 12 men (10%), with no Grade 4 event or rectal injury.
Conclusion:
5 year follow-up demonstrates durable oncologic control, safety, and functional preservation after a single whole-gland TULSA procedure. Intraprocedural imaging, positive MRI, and rising PSA at 1y predicted salvage therapy by 5y. Modern protocols informed by recurrences in TACT incorporate enhancements related to calcification screening, device positioning, diffusion-based targeting, thermal dose escalation and management of prostate swelling to improve disease control. A randomized controlled trial comparing TULSA with radical prostatectomy is underway (NCT05027477).