EDAP TMS announces final results of FARP study

EDAP TMS (EDAP) announced the positive final results of the Focal Ablation Versus Radical Prostatectomy, FARP, Study, the first randomized controlled trial completed comparing ultrasound energy-based focal ablation versus Robotic Prostatectomy. The study achieved its primary endpoint and demonstrated that the rate of treatment failure in the Focal Ablation group is non-inferior to that in the Radical Prostatectomy group at the final 36-month follow-up. FARP Trial Results: A total of 213 patients were enrolled in the study; 107 were randomized to FA and 106 to RP. 25% of the patients in the RP arm refused surgery and crossed-over to the FA arm. The two arms were equivalent in terms of mean age, PSA, index tumor diameter on MRI, prostate volume and Gleason Grade Group on biopsy. All included patients were evaluated following an intention-to-treat analysis. The proportion of treatment failure was 5.6% in the FA arm vs 7.9% in the RP arm, resulting in a statistical difference of 2.3% in favor of Focal Ablation.