Diagnostic Performance and Safety of 18 F-rhPSMA-7.3 Positron Emission Tomography in Men With Suspected Prostate Cancer Recurrence: Results From a Phase 3, Prospective, Multicenter Study (SPOTLIGHT)

Open AccessJournal of UrologyAdult Urology Article26 Apr 2023Diagnostic Performance and Safety of 18F-rhPSMA-7.3 PET in Men with Suspected Prostate Cancer Recurrence: Results from a Phase 3, Prospective, Multicenter Study (SPOTLIGHT) Ashesh B. Jani, Gregory C. Ravizzini, Benjamin A. Gartrell, Barry A. Siegel, Przemyslaw Twardowski, Daniel Saltzstein, Mark T. Fleming, Albert Chau, Phillip Davis, Brian F. Chapin, and David M. Schuster Ashesh B. JaniAshesh B. Jani *Correspondence: Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, GA (telephone: 404-778-3827; email: E-mail Address: [email protected]). Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia , Gregory C. RavizziniGregory C. Ravizzini Department of Nuclear Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas , Benjamin A. GartrellBenjamin A. Gartrell Montefiore Medical Center, New York , Barry A. SiegelBarry A. Siegel Division of Nuclear Medicine, Mallinckrodt Institute of Radiology and the Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri , Przemyslaw TwardowskiPrzemyslaw Twardowski John Wayne Cancer Institute, California , Daniel SaltzsteinDaniel Saltzstein Urology San Antonio, Texas , Mark T. FlemingMark T. Fleming Virginia Oncology Associates, US Oncology Research, Norfolk, Virginia , Albert ChauAlbert Chau Blue Earth Diagnostics Ltd, Oxford, United Kingdom , Phillip DavisPhillip Davis Blue Earth Diagnostics, Burlington, Massachusetts , Brian F. ChapinBrian F. Chapin Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, Texas , and David M. SchusterDavid M. Schuster Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University, Atlanta, Georgia View All Author Informationhttps://doi.org/10.1097/JU.0000000000003493AboutPDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookLinked InTwitterEmail Abstract Purpose: SPOTLIGHT (NCT04186845) evaluated diagnostic performance and safety of radiohybrid (rh) 18F-rhPSMA-7.3, a novel high-affinity PET radiopharmaceutical. Materials and Methods: Men with prostate cancer recurrence underwent PET/CT 50-70 minutes after intravenous administration of 296±20% MBq 18F-rhPSMA-7.3. To assess the co-primary endpoints (verified detection rate [VDR] and combined region-level positive predictive value [crPPV]), 3 blinded, independent central readers evaluated the scans. VDR is equivalent to the overall detection rate (DR) x PPV. Standard of Truth (SoT) was established for each patient using histopathology or confirmatory imaging. Statistical thresholds (lower bounds of the confidence intervals) of 36.5% and 62.5% were prespecified for VDR and crPPV, respectively. Additional endpoints included DR, VDR and crPPV in patients with histopathology SoT, and safety. Results: The overall 18F-rhPSMA-7.3 DR among all 389 patients with an evaluable scan was 83% (majority read). Among the 366 patients (median PSA, 1.27 ng/mL) for whom a SOT (histopathology [n=69]/confirmatory imaging only [n=297]) was available, VDR ranged from 51% (95%CI, 46.1-56.6) to 54% (95%, 48.8-59.3), exceeding the prespecified statistical threshold. crPPV ranged from 46% (95%CI, 42.0-50.3%) to 60% (95%CI, 55.1-65.5%) across the readers, not meeting the threshold. In the subset of patients with histopathology SoT, the VDR and crPPV were both above the prespecified thresholds (majority read, 81% [95%CI, 69.9-89.6] and 72% [95%CI, 62.5-80.7], respectively). No significant safety concerns were identified. Conclusions: 18F-rhPSMA-7.3 offers a clinically meaningful VDR for localization of recurrent prostate cancer. Despite missing the co-primary endpoint of crPPV, the totality of the data support the potential clinical utility of 18F-rhPSMA-7.3. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.© 2023 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.FiguresReferencesRelatedDetails Supplementary Materials Advertisement Copyright & Permissions© 2023 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.Keywordsprostatic neoplasmsmolecular imagingpositron-emission tomographyMetricsAuthor Information Ashesh B. Jani Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia *Correspondence: Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, GA (telephone: 404-778-3827; email: E-mail Address: [email protected]). More articles by this author Gregory C. Ravizzini Department of Nuclear Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas More articles by this author Benjamin A. Gartrell Montefiore Medical Center, New York More articles by this author Barry A. Siegel Division of Nuclear Medicine, Mallinckrodt Institute of Radiology and the Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri More articles by this author Przemyslaw Twardowski John Wayne Cancer Institute, California More articles by this author Daniel Saltzstein Urology San Antonio, Texas More articles by this author Mark T. Fleming Virginia Oncology Associates, US Oncology Research, Norfolk, Virginia More articles by this author Albert Chau Blue Earth Diagnostics Ltd, Oxford, United Kingdom More articles by this author Phillip Davis Blue Earth Diagnostics, Burlington, Massachusetts More articles by this author Brian F. Chapin Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, Texas More articles by this author David M. Schuster Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University, Atlanta, Georgia More articles by this author Expand All Advertisement PDF downloadLoading ...