The following is a summary of “Comparison Of Postoperative Complications Between Focal Ablation And Radical Prostatectomy For Intermediate-Risk Prostate Cancer: The Farp Randomized Control Trial,” published in the April 2023 issue of Urology by Baco et al.
The primary objective of this study is to analyze and compare the postoperative complications, classified according to Clavien-Dindo (CD) and Comprehensive Complication Index (CCI), among patients undergoing Focal Ablation (FA) using high-intensity focused ultrasound (HIFU) or transurethral ultrasound ablation (TULSA) versus Robot-Assisted Laparoscopic Prostatectomy (RALP) within the FARP Randomized Control Trial.
In this trial, 213 men diagnosed with unilateral intermediate-risk prostate cancer identified on MRI were randomly assigned in a 1:1 ratio to either FA or RALP, with a 27% cross-over rate from RALP to FA. Among them, 131 patients underwent FA (108 HIFU, 23 TULSA), and 75 underwent RALP with a unilateral nerve-sparing technique. Seven patients initially assigned to RALP chose not to proceed with surgery and remained untreated. All patients were monitored for at least one year with no dropouts. Complications were prospectively recorded in a digital patient journal, entered into the FARP database, and graded based on CD criteria. CCI, reflecting the cumulative severity of complications, was calculated as the sum of all complications with appropriate weightings. Differences in outcomes were analyzed using statistical tests such as the Chi-square test for binary outcomes and independent sample T-tests for continuous variables.
The comparison between FA and RALP revealed similar mean age, PSA levels, index tumor diameter, and prostate volume on MRI. However, the frequency of CD grade≥3 complications was significantly lower in the FA group compared to RALP (2% vs. 13%, p<0.001). Additionally, the mean CCI was numerically lower in FA (3.9) than in RALP (6.9), although the difference did not reach statistical significance (p=0.08).
In conclusion, Focal Ablation demonstrated notably better safety outcomes than Robot-Assisted Laparoscopic Prostatectomy, particularly in terms of the frequency and severity of CD grade≥3 complications and across the comprehensive CCI scale.
Source: auajournals.org/doi/10.1097/JU.0000000000003341.15
