MRI-guided transurethral ultrasound ablation (TULSA) is a novel, minimally invasive treatment for localized prostate cancer (PCa). This study aimed to evaluate the safety, efficacy, and functional outcomes of TULSA in treating organ-confined clinically significant prostate cancer (CsPCa). In this prospective, single-center, phase 2 study (NCT03350529), 60 men with MRI-visible and biopsy-proven CsPCa, including high-volume ISUP 1 (more than two positive cores or ≥50% cancer in a core) or ≥ISUP 2, were enrolled. Depending on patient preference and disease characteristics, patients underwent either whole-gland or focal TULSA. Adverse events (AEs) were graded using the Clavien-Dindo classification, while PSA levels, uroflowmetry, and quality of life (QoL) measures, including EPIC-26 and IIEF-5 questionnaires, were tracked every three months over the course of a year. Multiparametric MRI (mp-MRI) was performed at 6 and 12 months, and biopsies were taken at 12 months.
The study cohort had a median age of 66 years and a median PSA of 7.0 ng/ml. A total of 15 patients (25%) received whole-gland TULSA. AEs were mostly low-grade, with 33 Grade 2 events (such as UTIs) and 3 Grade 3b events (urinary obstructions, resolved via endoscopic procedures), with no Grade 4 or higher events reported. Re-TULSA was required in 22% of the patients. After 1 year, 70% of patients were free of in-field CsPCa, while 19% had out-field CsPCa. Radiologically, 82% showed no signs of residual disease on mp-MRI. Median PSA levels significantly decreased to 1.30 ng/ml, and uroflowmetry results remained stable, with an improvement in post-void residual volume. Erectile function declined in 7 patients, while QoL indicators, such as urinary incontinence and bowel scores, remained stable, and the irritative/obstructive domain improved. These findings suggest that TULSA provides effective, personalized ablation for CsPCa with minimal impact on QoL.
