Pd19-10 Psma Radio-Guided Surgery to Detect Nodal Metastases in Prostate Cancer Patients Undergoing Robot-Assisted Radical Prostatectomy and Extended Pelvic Lymph Node Dissection: Updated Results of a Planned Interim Analysis of a Prospective Phase 2 Study

You have accessJournal of UrologyProstate Cancer: Detection & Screening II (PD19)1 May 2024PD19-10 PSMA RADIO-GUIDED SURGERY TO DETECT NODAL METASTASES IN PROSTATE CANCER PATIENTS UNDERGOING ROBOT-ASSISTED RADICAL PROSTATECTOMY AND EXTENDED PELVIC LYMPH NODE DISSECTION: UPDATED RESULTS OF A PLANNED INTERIM ANALYSIS OF A PROSPECTIVE PHASE 2 STUDY Leonardo Quarta, Elio Mazzone, Giorgio Gandaglia, Armando Stabile, Donato Cannoletta, Daniele Robesti, Antony Pellegrino, Riccardo Leni, Vito Cucchiara, Simone Scuderi, Francesco Barletta, Paolo Zaurito, Ana Maria Samanes Gajate, Giorgio Brembilla, Matthias N. Van Oosterom, Fijs W.B. Van Leeuwen, Maria Picchio, Arturo Chiti, Francesco De Cobelli, Francesco Montorsi, and Alberto Briganti Leonardo QuartaLeonardo Quarta , Elio MazzoneElio Mazzone , Giorgio GandagliaGiorgio Gandaglia , Armando StabileArmando Stabile , Donato CannolettaDonato Cannoletta , Daniele RobestiDaniele Robesti , Antony PellegrinoAntony Pellegrino , Riccardo LeniRiccardo Leni , Vito CucchiaraVito Cucchiara , Simone ScuderiSimone Scuderi , Francesco BarlettaFrancesco Barletta , Paolo ZauritoPaolo Zaurito , Ana Maria Samanes GajateAna Maria Samanes Gajate , Giorgio BrembillaGiorgio Brembilla , Matthias N. Van OosteromMatthias N. Van Oosterom , Fijs W.B. Van LeeuwenFijs W.B. Van Leeuwen , Maria PicchioMaria Picchio , Arturo ChitiArturo Chiti , Francesco De CobelliFrancesco De Cobelli , Francesco MontorsiFrancesco Montorsi , and Alberto BrigantiAlberto Briganti View All Author Informationhttps://doi.org/10.1097/01.JU.0001009448.41537.64.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Extended pelvic nodal dissection (ePLND) is the gold standard for nodal staging in prostate cancer (PCa). PSMA radio-guided surgery (PSMA-RGS) could help lymph node invasion (LNI) identification during robot-assisted radical prostatectomy (RARP). Herein, we present an update of interim analyses of a phase 2 prospective study (NCT04832958) aimed to assess the feasibility and accuracy of PSMA-RGS. METHODS: Overall, 56 patients cN0cM0 PCa at conventional imaging with Briganti nomogram LNI risk >5% were enrolled. Among those, 34 underwent PSMA-RGS between June 2021 and September 2023. All patients received preoperative PSMA PET. 99mTc-PSMA I&S (PiChem, Austria) was administered intravenously the day before surgery followed by SPECT/CT. A drop-in gamma probe (CrystalPhotonics, Germany) was used for in-vivo and ex-vivo measurements. All positive lesions (count rate ≥2 compared to background) were excised and an ePLND including obturator, internal and external iliac nodal regions was completed. Adverse events (AEs), perioperative outcomes, accuracy of PSMA-RGS for LNI, and PSA persistence were evaluated. RESULTS: Overall, 15 (44%), 11 (32%) and 8 (24%) patients had intermediate-risk, high-risk, and locally advanced PCa and 10 (29%) had nodal uptake at PSMA PET. No AEs were recorded after 99mTc-PSMA. Median operative time, blood loss and length of stay were 222 min, 100 mL, and 5 days. No intraoperative complications were recorded. Overall, 2 patients experienced a 30-day complication (Clavien-Dindo 2 and 3). Positive margins and PSA persistence were reported in 7 (20%) and 6 (17%) cases. A total of 174 specimens were resected, including 872 nodes (median 23 per patient). Overall, 12 (35%) patients had LNI. At per region analysis, the sensitivity, specificity, positive (PPV) and negative predictive value (NPV) were 73%, 89%, 48%, 96% (accuracy 87%), and 54%, 98%, 80%, 94% (accuracy 92%) for a count rate ≥2 vs 3, respectively. At a per patient analysis, these figures were 82%, 78%, 64%, 90% (accuracy 79%), and 73%, 96%, 89%, 88% (accuracy 88%) for a count rate ≥2 vs 3. PSMA-RGS allowed to detect suspicious spots outside the pelvic template in 5 (15%) patients. CONCLUSIONS: Updated results confirm that 99mTc-PSMA-RGS during RARP is a safe and feasible procedure. A cut-off of ≥3 vs ≥2 target-to-background count rate provides higher accuracy and lower false positive findings, at the cost of missing a higher proportion of positive nodes. Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e444 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Leonardo Quarta More articles by this author Elio Mazzone More articles by this author Giorgio Gandaglia More articles by this author Armando Stabile More articles by this author Donato Cannoletta More articles by this author Daniele Robesti More articles by this author Antony Pellegrino More articles by this author Riccardo Leni More articles by this author Vito Cucchiara More articles by this author Simone Scuderi More articles by this author Francesco Barletta More articles by this author Paolo Zaurito More articles by this author Ana Maria Samanes Gajate More articles by this author Giorgio Brembilla More articles by this author Matthias N. Van Oosterom More articles by this author Fijs W.B. Van Leeuwen More articles by this author Maria Picchio More articles by this author Arturo Chiti More articles by this author Francesco De Cobelli More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement PDF downloadLoading ...