Lesion‐targeted transurethral ultrasound ablation for MRI ‐visible localised prostate cancer: 12‐month phase II results

Objectives To evaluate oncological efficacy and safety of transurethral ultrasound ablation (TULSA) treatment, we defined the co‐primary endpoints as the absence of International Society of Urological Pathology Grade Group (ISUP GG) ≥2 cancer at 12‐month biopsy and the absence of Clavien–Dindo Grade ≥III complications within 3 months, while secondary endpoints included magnetic resonance imaging (MRI), prostate‐specific antigen (PSA), urodynamic, and patient‐reported outcomes. We report 12‐month outcomes of lesion‐targeted TULSA as first‐line therapy in a broadly selected prospective cohort. Patients and Methods In this single‐centre IDEAL‐2a study (NCT03814252), men with MRI‐visible, biopsy‐concordant prostate cancer (ISUP GG2–4 or GG1 in men declining active surveillance) underwent lesion‐targeted TULSA with a ≥5‐mm treatment margin. Eligibility was intentionally broad: provided the disease was organ‐confined and technically amenable to treatment, patients were not excluded based on lesion size, location, laterality, multifocality, capsular contact or bulging, number of positive biopsy cores, or adverse pathological features. Results In all, 59 men were treated. The median (interquartile range [IQR]) age was 67 (61–72) years, PSA level 6.9 (4.5–9.8) ng/mL, and prostate volume 29 (25–36) mL. Baseline GG1–4 distribution was 10%, 63%, 22%, and 5%, respectively. No Grade ≥III complications occurred within 3 months. Two Clavien–Dindo Grade III events related to urethral stricture or bladder outlet obstruction occurred during 12 months and resolved with intervention. At 12 months, 70% (38/54) of patients were free of in‐field GG ≥2 cancer and 52% (28/54) were free of prostate‐wide GG ≥2 cancer. MRI was negative in 86% (48/56), and median (IQR) PSA decreased to 1.30 (0.63–2.20) ng/mL. Urinary and bowel function remained stable, while sexual function declined modestly; 72% (21/29) of initially potent men retained erections. Limitations include the single‐arm design and short follow‐up. Conclusions Lesion‐targeted TULSA preserved urinary function and provided 70% freedom from in‐field GG ≥2 cancer, with a 3.4% 12‐month Clavien–Dindo Grade III complication rate. Larger comparative studies with longer follow‐up are warranted.