Magnetic Resonance Imaging-guided Transurethral Ultrasound Ablation (TULSA) of Localized Prostate Cancer: A prospective Trial.

PURPOSE: To evaluate the effectiveness and safety of the TULSA-PRO device in treating organ-confined low-risk to intermediate-risk prostate cancer (PCa).

MATERIALS AND METHODS: This prospective, single-center clinical trial included 25 men with organ-confined low-risk/intermediate-risk PCa (prostate-specific antigen ≤ 15 ng/mL, International Society of Urological Pathology ≤ 2, magnetic resonance [MR] imaging ≤ iT2c). Patients underwent MR imaging-guided focused ultrasound treatment, followed by clinical reevaluation at 1, 3, 6, and 12 months. The primary end point was the absence of clinically significant cancer (CSC) on the 12-month systematic and targeted biopsy. Secondary end points included safety, quality of life, prostate-specific antigen variation, and functional outcomes.

RESULTS: At 12 months, 43.5% of patients (10/23) had CSC on biopsy, with a recurrence-free survival rate of 40% and a treatment-free survival rate of 72% after a median follow-up of 37 months (range, 14-54 months). Functional outcomes revealed stress urinary incontinence in 6 patients, overactive bladder in 8, and severe erectile dysfunction in 7 of the 13 preprocedurally potent patients. Otherwise, the safety profile was favorable, with no severe adverse event related to the treatment. MR imaging follow-up detected suspicious lesions in 3 of the 10 (30%) patients with CSC at 12 months.

CONCLUSIONS: Transurethral ultrasound ablation shows promise as a focal treatment for localized PCa, although it may not be universally curative. Continued surveillance and further studies are required to assess long-term effectiveness and to optimize functional outcomes.