Lymph node dissection based on 18F-PSMA PET/CT during radical prostatectomy for intermediate and high risk prostate cancer: interim results of a prospective, randomized study.

Background: Pelvic lymph node dissection (PLND) is integral to prostate cancer staging, but its therapeutic value remains debated. PSMA PET/CT has shown high accuracy in detecting lymph node metastasis (LNM). This study evaluates the feasibility of performing PLND based on PSMA PET/CT findings during robotic-assisted radical prostatectomy (RARP).

Methods: In this prospective, randomized study, biopsy-confirmed prostate cancer (PCa) patients with intermediate or high risk were enrolled. Patients with distant metastasis or prior endocrine therapy were excluded. All underwent 18F-PSMA PET/CT imaging, and those with LNM were assigned to Group A. Patients without LNM were randomized in a 1:1 ratio into Groups B and C. All patients underwent RARP and Groups A and B with PLND while Group C without. The primary outcomes were PSMA PET/CT accuracy in detecting LNM and oncological results. This trial is registered with the Chinese Clinical Trial Registry (ChiCTR2200063256).

Results: Between September 2022 and August 2023, 120 PCa patients were enrolled. The sensitivity, specificity, accuracy, positive predictive value (PPV), and NPV of PSMA PET/CT were 76.5%, 86.8%, 65.0%, 92.0%, and 84.3%. There were no significant differences in clinical parameters, progression-free survival (PFS) or PSA persistence between Groups B and C. However, PLND patients had longer surgical times, hospital stays, and higher complication rates.

Conclusions: PSMA PET/CT offers high specificity and NPV in detecting LNM.LND may be unnecessary for node-negative patients identified by PSMA PET/CT, with close follow-up recommended for those not undergoing LND.