Five-year outcomes after transurethral ultrasound ablation (TULSA) of localised prostate cancer
Author Block: J. Fütterer1, D. Bonekamp2, T. Persigehl3, S. Arora4, S. Raman5, K. J. Macura6, A. Oto7, T. Tirkes8, D. Costa9; 1Nijmegen/NL, 2Heidelberg/DE, 3Cologne/DE, 4New Haven, CT/US, 5Los Angeles, CA/US, 6Baltimore, MD/US, 7Chicago, IL/US, 8Indianapolis, IN/US, 9Dallas, TX/US
Purpose: This study aimed to discuss the magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) of the prostate using ultrasound to thermally coagulate tissue in-bore. Closed-loop control matches real-time feedback from MRI thermometry to the ablative energy administered to the prescribed volume. We report the 5-year follow-up from the TACT pivotal study.
Methods or Background: 115 men with localised prostate cancer (PCa) were enrolled across 13 sites in 5 countries. Eligibility included Grade Group (GG) 1-2, stage≤T2b, and PSA≤15 ng/mL. Men received a single, whole-gland TULSA treatment sparing the prostatic urethra and urinary sphincter. Primary endpoints at 1 year were PSA reduction and adverse events. Secondary endpoints included 10-core biopsy and mpMRI at 1 year and adverse events, quality of life, PSA, and salvage treatment to 5 years.
Results or Findings: At baseline, (median [IQR]) age was 65 (59-69) years. By 5 years, PSA decreased from 6.3 (4.6-7.9) ng/mL pre-treatment to 0.63 (0.18-1.9) ng/mL (n=68), and 25 men (21.7%) received salvage treatment, without unexpected complications (10 prostatectomy, 11 radiotherapy, 3 ADT, 1 surgery and radiation). Median prostate volume at baseline and 1 year was 37.3 and 2.8 cc (92% decrease). At baseline and 1 year, 72/115 (63%) and 17/111 (15%) had ≥GG2 disease. By 5 years, 61/66 (92%) recovered pad-free continence; 80/92 (87%) preserved IIEFQ2≥2 erections. 12 men incurred Grade 3 adverse events (10%), with no Grade≥4 event or rectal injury. Intraprocedural imaging parameters, positive MRI and rising PSA at 1 year predicted the risk of salvage therapy by 5 years.
Conclusion: Effective disease control was achieved in 78% of men at 5 years after a single TULSA procedure. Favourable safety and functional outcomes were durable to 5 years.
Limitations: Modern protocols may translate into improved rates of local control in contemporary cases. A randomized controlled trial comparing TULSA with radical prostatectomy is underway (NCT05027477).
Funding for this study: The funding for this study was received from Profound Medical.
Has your study been approved by an ethics committee? Yes
Ethics committee - additional information: No information was provided by the submitter.