Introduction:

The Customized TULSA-PRO Ablation Registry (“CARE”, NCT05001477) was established to prospectively collect real-world data from patients treated with MRI-guided transurethral ultrasound ablation. Here we report the first multicenter efficacy outcomes from CARE for patients treated with focal to whole-gland ablation plans for primary, localized PCa.

Methods:

Between July 2020 and June 2024, 181 patients across 5 U.S. centers (3 academic hospitals, 1 imaging center, and 1 private urology group) underwent TULSA according to the local standard of care and consented to prospective data collection. Follow-up included PSA, quality of life questionnaires, and Clavien-Dindo adverse events at 0, 3, 6, 12 months and annually thereafter, along with MRI, biopsy, and additional PCa treatment. Here we report baseline characteristics and efficacy and safety outcomes at 1-year post-treatment for the subgroup treated for primary prostate cancer (PCa).

Results:

Of the 181 patients enrolled in CARE, 165 (91%) had primary localized PCa. Baseline, median (IQR) age, PSA, and prostate volume were 68 (64-73) years, 6.5 (4.9-9.4) ng/mL, and 41 (32-53) cc. The ISUP grade group (GG) distribution at baseline was: GG1 (14%), GG2 (61%), GG3 (18%), GG4 (5%), unknown (2%). Ablation plans were lesion-targeted (19%), hemi-gland (5%), subtotal (29%), whole-gland (39%), and unknown (8%). Of 101 patients with 1-year follow-up: 94 patients had follow-up MRI available, 12 (12%) had evidence of residual/recurrent disease; 39 patients underwent follow-up biopsy, 6 (6%) had histological evidence of GG2 disease. Median (IQR) PSA decreased 90 (73-96)% to a nadir of 0.75 (0.25-1.73) ng/mL. 4 men received salvage treatment between 9-24 months: 2 hormonal therapy, 2 external beam radiation therapy plus hormonal therapy, all without unexpected complications.  Among patients with minimum 12 months follow-up, 91% are pad-free, and 96% leak-free (EPIC). By 6 months, 21% reported erectile dysfunction, ongoing in 17% by 1.5 years. Median (IQR) IPSS was stable from 7 (4-13) at baseline and 6 (3-11) at 1 year. Five patients (3%) incurred 7 Grade III complications, including surgical correction for urinary incontinence or erectile dysfunction, and endoscopic management of retention/stenosis/bladder neck contracture.

Conclusion:

This first multicenter report of real-world clinical efficacy for MRI-guided TULSA highlights excellent radiologic and histologic control of primary PCa in patients with GG1-GG4 disease treated with focal to whole-gland ablation and supports TULSA as a safe and effective tool for managing PCa in the routine clinical setting.  Level 1 evidence is being generated by an ongoing randomized controlled trial (CAPTAIN, NCT05027477) comparing safety and efficacy of TULSA to radical prostatectomy.

Funding: This study is sponsored by Profound Medical.