Diagnostic Performance and Safety of <sup>18</sup> F-rhPSMA-7.3 Positron Emission Tomography in Men With Suspected Prostate Cancer Recurrence: Results From a Phase 3, Prospective, Multicenter Study (SPOTLIGHT)
Ashesh B. Jani, Gregory Ravizzini, Benjamin A. Gartrell, Barry A. Siegel, Przemyslaw Twardowski, Daniel R. Saltzstein, Mark T. Fleming, Albert Chau, Phillip Davis, Brian F. Chapin, David M. Schuster, Mohamad E. Allaf, Ryan Avery, Norbert Avril, Helen Barker, Laurence Belkoff, Peter J. Boström, Michael L. Cher, Diane Chisholm, Matthew F. Covington, Ian Cox, Giuseppe Esposito, Peter Gardiner, David Gauden, Brian Helfand, Rick Hermsen, David Josephson, Matthew D. Kay, Bridget F. Koontz, Lale Kostakoğlu, Phillip H. Kuo, William C. Lavely, Ing Han Liem, Mary A. Lokuta, Benjamin Lowentritt, Jeff M. Michalski, Matthew P. Miller, Karen Mourtzikos, Russell K. Pachynski, R. H. C. Penny, Morand Piert, Andrei S. Purysko, Soroush Rais‐Bahrami, Bital Savir-Baruch, Rik Somford, Ashutosh Tewari, Edward Uchio, Don C. Yoo, Katherine Zukotynski
Abstract
PURPOSE: F-rhPSMA-7.3, a novel high-affinity positron emission tomography radiopharmaceutical. MATERIALS AND METHODS: Additional end points included detection rate, verified detection rate, and combined region-level positive predictive value in patients with histopathology standard of truth, and safety. RESULTS: F-rhPSMA-7.3 detection rate among all 389 patients with an evaluable scan was 83% (majority read). Among the 366 patients (median prostate-specific antigen 1.27 ng/mL) for whom a standard of truth (histopathology [n=69]/confirmatory imaging only [n=297]) was available, verified detection rate ranged from 51% (95% CI 46.1-56.6) to 54% (95% CI 48.8-59.3), exceeding the prespecified statistical threshold. Combined region-level positive predictive value 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 standard of truth, the verified detection rate and combined region-level positive predictive value 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: F-rhPSMA-7.3.