Prostate-specific membrane antigen Radioguided Surgery to Detect Nodal Metastases in Primary Prostate Cancer Patients Undergoing Robot-assisted Radical Prostatectomy and Extended Pelvic Lymph Node Dissection: Results of a Planned Interim Analysis of a Prospective Phase 2 Study

• DOI: 10.1016/j.eururo.2022.06.002
• Publication Date: 2022-07-22T11:21:15Z
• Authors: Giorgio Gandaglia; Elio Mazzone; Armando Stabile; Antony Pellegrino; Vito Cucchiara; Francesco Barletta; Simone Scuderi; Daniele Robesti; Riccardo Leni; Ana Maria Samanes...; Maria Picchio; Luigi Gianolli; Giorgio Brembilla; Francesco De Cobelli; Matthias N. van O...; Fijs W.B. van Lee...; Francesco Montorsi; Alberto Briganti
• Keywords: Glutamate carboxypeptidase II

Extended pelvic nodal dissection (ePLND) represents the gold standard for staging in prostate cancer (PCa). Prostate-specific membrane antigen (PSMA) radioguided surgery (RGS) could identify lymph node invasion (LNI) during robot-assisted radical prostatectomy (RARP). To report planned interim analyses of a phase 2 prospective study (NCT04832958) aimed at describing PSMA-RGS RARP. A trial enrolling 100 patients with intermediate- or high-risk cN0cM0 PCa conventional imaging risk LNI >5% was conducted. Overall, 18 were enrolled between June 2021 and March 2022. Among them, 12 underwent represented cohort. All received 68Ga-PSMA positron emission tomography (PET)/magnetic resonance imaging; 99mTc-PSMA-I&S synthesised administered intravenously day before surgery, followed by single-photon computed tomography/computed tomography. Drop-In gamma probe used vivo measurements. positive lesions (count rate ≥2 compared background) excised ePLND performed. Side effects, perioperative outcomes, performance characteristics measured. four (33%), six (50%), two (17%) had intermediate-risk, high-risk, locally advanced PCa. pathologic uptake PSMA PET. The median operative time, blood loss, length stay 230 min, ml, 5 d, respectively. No adverse events intraoperative complications recorded. One patient experienced 30-d complication (Clavien-Dindo 2; 8.3%). three (25%) ePLND. At per-region on 96 areas, sensitivity, specificity, predictive value, negative value 63%, 99%, 83%, 96%, On per-patient level, values 67%, 100%, 90%, Robot-assisted primary is safe feasible procedure characterised acceptable specificity but suboptimal missing micrometastatic disease. identification metastases undergoing extended dissection. However, this approach might still miss dissemination.