PSMA Radio-guided Surgery to Identify Lymph Node Metastases in Prostate Cancer Patients Undergoing Robot-assisted Radical Prostatectomy and Extended Pelvic Lymph Node Dissection: Results of a Phase 2 Prospective Study.
Leonardo Quarta, Paolo Zaurito, Alessandro Viti et al.
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In 30 seconds
This prospective phase 2 study assessed the feasibility and diagnostic performance of PSMA radio-guided surgery during robot-assisted radical prostatectomy and extended pelvic lymph node dissection in men with localized prostate cancer and a lymph node invasion risk >5%. Of 82 enrolled patients, 62 completed all procedures and were analysed. No tracer-related adverse events or intraoperative complications were recorded. Compared with preoperative PSMA PET, radio-guided surgery identified two additional patients with pathologically node-positive disease; per-patient positive predictive value was lower (50% vs 70%), while negative predictive value was the same (83% vs 83%).
Key findings
- PSMA radio-guided surgery identified two additional patients with pathologically node-positive disease compared with preoperative PSMA PET.
- Per-patient positive predictive value was 50% vs 70%, while negative predictive value was 83% vs 83% for radio-guided surgery and PSMA PET, respectively.
- Among patients with molecular imaging node-positive disease, per-region positive predictive value was 55% vs 42% and negative predictive value was 85% vs 81%.
- No tracer-related adverse events or intraoperative complications were recorded; four patients had a Clavien-Dindo grade 3 complication within 30 d.
Why it matters
The findings suggest that intraoperative PSMA guidance may reveal nodal disease not detected on preoperative PSMA PET and help extend dissection in patients with imaging-positive nodes. However, the negative predictive value was not sufficient to support omitting extended dissection when radio-guided findings were negative, underscoring the distinction between added detection and reliable exclusion of nodal involvement.
What to keep in mind
Only 62 of 82 enrolled patients completed all study procedures and were included in the final analyses. The study was a phase 2 prospective trial, and the reported negative predictive value was suboptimal for avoiding extended dissection.