This phase 2 prospective trial (NCT04832958) evaluated the feasibility and accuracy of [99mTc]Tc-PSMA-I&S radio-guided surgery (RGS) during robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND) in 62 men with localized prostate cancer and lymph node invasion (LNI) risk >5%, compared against preoperative PSMA PET.
PSMA-RGS detected 2 additional pN1 patients missed by PSMA PET. Per-patient PPV/NPV were 50%/83% for RGS vs. 70%/83% for PSMA PET; per-region PPV/NPV in miN1 patients were 55%/85% for RGS vs. 42%/81% for PSMA PET. No tracer-related adverse events or intraoperative complications occurred; 4 patients had Clavien-Dindo grade 3 postoperative complications.
- Small sample: only 62 of 82 enrolled patients completed all study procedures, limiting statistical power. - The suboptimal NPV (83%) means PSMA-RGS cannot safely replace ePLND in patients with LNI risk >5% and negative intraoperative findings. - Single-center phase 2 design limits generalizability.
PSMA-RGS can find node-positive disease missed by preoperative PSMA PET and may help extend the dissection template in PET-positive patients, but its NPV is too low to justify skipping ePLND in men with LNI risk >5% and negative intraoperative probe findings.
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