LBA02-05 ACCURACY OF 68GA-PSMA-11 FOR PELVIC NODAL METASTASIS DETECTION PRIOR TO RADICAL PROSTATECTOMY AND PELVIC LYMPH NODE DISSECTION: A MULTICENTER PROSPECTIVE PHASE 3 IMAGING STUDY (2020)

You have accessJournal of UrologyLate-Breaking Abstracts (LBA2)1 Apr 2020LBA02-05 ACCURACY OF 68GA-PSMA-11 FOR PELVIC NODAL METASTASIS DETECTION PRIOR TO RADICAL PROSTATECTOMY AND PELVIC LYMPH NODE DISSECTION: A MULTICENTER PROSPECTIVE PHASE 3 IMAGING STUDY Thomas* Hope, Wesley Armstrong, Vishnu Murthy, Roxanna Juarez, Courtney Lawhn Heath, Spencer Behr, Francesco Barbato, Francesco Ceci, Andrea Farolfi, Sarah Schwarzenboeck, Marcus Unterrainer, Helle Zacho, Hao Nguyen, Matthew Cooperberg, Peter Carroll, Robert Reiter, Stuart Holden, Wolfgang Fendler, Shaojun Zhu, Matthias Eiber, Ken Herrmann, Johannes Czernin, and Jeremie Calais Thomas* HopeThomas* Hope More articles by this author , Wesley ArmstrongWesley Armstrong More articles by this author , Vishnu MurthyVishnu Murthy More articles by this author , Roxanna JuarezRoxanna Juarez More articles by this author , Courtney Lawhn HeathCourtney Lawhn Heath More articles by this author , Spencer BehrSpencer Behr More articles by this author , Francesco BarbatoFrancesco Barbato More articles by this author , Francesco CeciFrancesco Ceci More articles by this author , Andrea FarolfiAndrea Farolfi More articles by this author , Sarah SchwarzenboeckSarah Schwarzenboeck More articles by this author , Marcus UnterrainerMarcus Unterrainer More articles by this author , Helle ZachoHelle Zacho More articles by this author , Hao NguyenHao Nguyen More articles by this author , Matthew CooperbergMatthew Cooperberg More articles by this author , Peter CarrollPeter Carroll More articles by this author , Robert ReiterRobert Reiter More articles by this author , Stuart HoldenStuart Holden More articles by this author , Wolfgang FendlerWolfgang Fendler More articles by this author , Shaojun ZhuShaojun Zhu More articles by this author , Matthias EiberMatthias Eiber More articles by this author , Ken HerrmannKen Herrmann More articles by this author , Johannes CzerninJohannes Czernin More articles by this author , and Jeremie CalaisJeremie Calais More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000958.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To determine the accuracy of 68Ga-PSMA-11 PET for the detection of pelvic nodal metastases (N1) compared to histopathology at time of radical prostatectomy (RP). METHODS: This is a prospective multicenter single-arm open-label phase 3 imaging trial. Patients with intermediate to high risk prostate cancer (PCa) considered for RP with lymph node dissection (PLND) were enrolled at the University of California, Los Angeles (UCLA) and at the San Francisco (UCSF) (NCT03368547, NCT02611882, NCT02919111), and underwent one 68Ga-PSMA-11 PET. The primary endpoint was the sensitivity (Se) and specificity (Sp) of 68Ga-PSMA-11 PET for the N1 detection compared to PLND histopathology (reference-standard) on a per patient basis using nodal region-based correlation. Each scan was read by three blinded independent central readers (BICR). Consensus was based on majority rule. RESULTS: From December 2015 to August 2019, 633 patients underwent one 68Ga-PSMA-11 PET for primary staging, and 277/633 (44%) subsequently underwent RP and PLND. The median initial PSA was 11.1 [0.04-147]. 75/277 patients (27%) had N1 disease per histopathology. Using a regional based analysis, Se, Sp, positive predictive value (PPV) and negative predictive value (NPV) for N1 detection was 0.40 [0.34, 0.46], 0.95 [0.92, 0.97], 0.75 [0.70, 0.80], 0.81 [0.76, 0.85], respectively. Se was higher for patients with higher PSA: 0.29 [0.24, 0.35] for PSA<11 ng/ml versus 0.48 [0.42, 0.54] for PSA > 11. Se was higher when the nodes were larger: 0.30 [0.25, 0.36] for nodes < 10 mm versus 0.68 [0.63, 0.74] for nodes > 10. The average node size in true positive patients was 10 mm versus 4 mm in false negative patients. CONCLUSIONS: In intermediate to high risk PCa patients who underwent RP and PLND, 68Ga-PSMA-11 PET detected pelvic nodal metastases with a sensitivity of 0.40 and a specificity of 0.95. Higher PSAs and larger node size correlated with increased sensitivity. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1116-e1117 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Thomas* Hope More articles by this author Wesley Armstrong More articles by this author Vishnu Murthy More articles by this author Roxanna Juarez More articles by this author Courtney Lawhn Heath More articles by this author Spencer Behr More articles by this author Francesco Barbato More articles by this author Francesco Ceci More articles by this author Andrea Farolfi More articles by this author Sarah Schwarzenboeck More articles by this author Marcus Unterrainer More articles by this author Helle Zacho More articles by this author Hao Nguyen More articles by this author Matthew Cooperberg More articles by this author Peter Carroll More articles by this author Robert Reiter More articles by this author Stuart Holden More articles by this author Wolfgang Fendler More articles by this author Shaojun Zhu More articles by this author Matthias Eiber More articles by this author Ken Herrmann More articles by this author Johannes Czernin More articles by this author Jeremie Calais More articles by this author Expand All Advertisement PDF downloadLoading ...