MP73-15: Comparison of postoperative complications between Focal Ablation and Radical Prostatectomy for intermediate-risk prostate cancer: The FARP Randomized Control Trial.
Introduction: The aim of this study is to report and compare postoperative complications at 1 year, in Clavien-Dindo classification (CD) and Comprehensive Complication Index (CCI), for patients who were treated by Focal Ablation (FA), using high-intensity focused ultrasound (HIFU) or transurethral ultrasound ablation (TULSA), vs. Robot-Assisted Laparoscopic Prostatectomy (RALP) in the FARP Randomized Control Trial. Methods: 213 men with biopsy-proven unilateral intermediate-risk prostate cancer visible on MRI were randomized 1:1 to FA or RALP with a cross-over rate of 27 % from RALP to FA. 131 patients were treated with FA (108 HIFU, 23 TULSA), and 75 with RALP using a unilateral nerve-sparing technique. Seven patients who were randomized to RALP declined to undergo prostatectomy and remained untreated. All patients were followed for at least 1 year with no drop-out. Complications were prospectively registered in a digital patient journal, entered in the FARP database, and graded according to CD. CCI was calculated as the sum of all complications and weighted for severity. Differences in binary outcomes were assessed with a Chi-square test, while continuous variables were evaluated using an independent sample T-test. Results: Mean age, PSA, index tumor diameter, and prostate volume on MRI for FA vs. RALP were: 64 vs. 66 years, p=0.3; 8.6 vs. 8.5 ng/ml, p=0.9; 14.5 vs. 15.5 mm, p=0.2; and 41.3 vs. 41.7 ml, p= 0.9. Grade CD 1 and 2 complications in FA vs. RALP were 17% vs. 25 %, p=0.18. The incidence of serious complications defined as CD = 3 was 2 % vs. 13 %, p <0.001. (Tab 1). The mean CCI was 3.9 and 6.9 in FA and RALP, respectively; p=0.08. Conclusions: FA of prostate was associated with significantly better safety outcomes as compared to RALP considering the frequency and severity of CD grade = 3 complications and across the entire CCI scale. SOURCE OF Funding: No
