Prospective Multicenter Study on the Predictive Role of Node-RADS Score in Patients With Prostate Cancer Who Are Candidates for Radical Prostatectomy: Comparative Analysis with Validated Nomograms and PET/CT Scan.

BACKGROUND AND OBJECTIVE: This is the first prospective study analyzing the predictive value of preoperative Node-Reporting And Data System (RADS) determination at imaging for pelvic lymph node (PLN) involvement in cases of prostate cancer (PCa) considered for radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND). Node-RADS was compared with the validated predictive nomograms Briganti 2012, Gandaglia 2017, and Briganti 2019, and with prostate-specific membrane antigen - positron emission tomography/computed tomography (PSMA-PET/CT) total body scan. METHODS: A total of 267 patients with a histological diagnosis of PCa undergoing RP with an ePLND were prospectively examined. Overall, n = 104 patients underwent PSMA-PET/CT. Node-RADS determination of PLNs was centrally performed using preoperative magnetic resonance imaging and compared with the validated nomograms and PSMA-PET/CT. Correspondence in terms of positivity and localization with final pathology was analyzed. RESULTS: Node-RADS exceeded PSMA-PET/CT in overall accuracy (area under the curve [AUC] 0.637 vs 0.526), whereas the Briganti 2019 nomogram achieved the highest AUC (0.711). Combining Node-RADS and Briganti 2019 improved performance further (AUC 0.719). Node-RADS showed high specificity (0.993) and positive predictive value (0.506), useful to confirm nodal involvement, whereas Briganti 2019 demonstrated high sensitivity (0.952) and excellent NPV (0.960), useful to exclude nodal disease. PET/CT exhibited limited sensitivity and anatomical correspondence. At multivariate analysis, a high Node-RADS score (4-5) and pathological tumor (pT) stage (pT3) were the only variables associated with a higher risk of positive PLNs involvement at final pathology (adjusted odds ratio [aOR]: 12.60, 95% confidence interval [CI] 2.99-52.96, p < 0.001 for Node-RADS 4-5 and aOR 16.98, 95% CI 4.29-67.17, p < 0.001 for pT3b). CONCLUSIONS: Node-RADS, especially when combined with the Briganti 2019 nomogram, showed promising performance as a structured radiologic tool for preoperative nodal staging in this selected ePLND-eligible cohort.