Ultrasound-Guided Focal Ablation vs. Radical Prostatectomy for Unilateral Clinically Significant Prostate Cancer: A Two-Year Randomized Clinical Trial

This randomized controlled trial (NCT03668652) aimed to assess the non-inferiority of treatment failure rates after two years in patients with unilateral clinically significant prostate cancer (PCa) undergoing focal ablation (FA) versus robot-assisted radical prostatectomy (RP). Inclusion criteria for participants included unilateral PCa with biopsy results indicating >5 mm ISUP grade 1 or any ISUP grade 2-3, a prostate-specific antigen (PSA) level of ≤20 ng/ml, and an age of <80 years. The primary outcome was the difference in treatment failure after two years, with a non-inferiority margin set at 15%. All patients underwent bi-parametric MRI, targeted biopsies using the Koelis-Trinity MRI-TRUS fusion system, and were then randomized into two groups: FA, using either transrectal high-intensity focused ultrasound (HIFU) or transurethral ultrasound ablation (TULSA PRO), and RP as unilateral nerve-sparing surgery. Treatment failure for the FA group was defined as the necessity for secondary RP or radiation therapy due to high-risk PCa, while in the RP group, treatment failure was characterized by a post-treatment PSA level exceeding 0.2 ng/ml. A total of 213 patients were enrolled, with 107 receiving FA and 106 undergoing RP. Following randomization, 26 patients (25%) initially assigned to RP opted for FA. No significant differences were noted between the groups in terms of age, PSA levels, MRI-measured index tumor diameter, and prostate volume at baseline. The results indicated a treatment failure rate of 6.5% in the FA group and 7.5% in the RP group, demonstrating that FA was non-inferior to RP after two years.