Diagnostic Performance and Safety of 18F-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 C. Ravizzini, Benjamin A. Gartrell, Barry A. Siegel, Przemyslaw Twardowski, Daniel Saltzstein, Mark T. Fleming, Albert Chau, Phillip Davis, Brian F. Chapin, David M. Schuster, Mohamad Allaf, Ryan J. Avery, Norbert Avril, Helen Barker, Laurence Belkoff, Peter Bostrom, Michael L. Cher, Diane Chisholm, Matthew F. CovingtonIan Cox, Giuseppe Esposito, Peter Gardiner, David Gauden, Brian Helfand, Rick Hermsen, David Josephson, Matthew Kay, Bridget F. Koontz, Lale Kostakoglu, Phillip Kuo, William Lavely, Ing Han Liem, Mary Lokuta, Benjamin Lowentritt, Jeff Michalski, Matthew P. Miller, Karen Mourtzikos, Russell Pachynski, Ross Penny, Morand Piert, Andrei Purysko, Soroush Rais-Bahrami, Bital Savir-Baruch, Rik Somford, Ashutosh Tewari, Edward Uchio, Don Yoo, Katherine Zukotynski

Research output: Contribution to journalArticlepeer-review

13 Scopus citations

Abstract

Purpose:SPOTLIGHT (NCT04186845) evaluated diagnostic performance and safety of radiohybrid 18F-rhPSMA-7.3, a novel high-affinity positron emission tomography radiopharmaceutical.Materials and Methods:Men with prostate cancer recurrence underwent positron emission tomography/CT 50-70 minutes after intravenous administration of 296±20% MBq 18F-rhPSMA-7.3. To assess the coprimary end points (verified detection rate and combined region-level positive predictive value), 3 blinded, independent central readers evaluated the scans. Verified detection rate is equivalent to the overall detection rate × positive predictive value. Standard of truth 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 verified detection rate and combined region-level positive predictive value, respectively. 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:The overall 18F-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:18F-rhPSMA-7.3 offers a clinically meaningful verified detection rate for localization of recurrent prostate cancer. Despite missing the coprimary end point of combined region-level positive predictive value, the totality of the data support the potential clinical utility of 18F-rhPSMA-7.3.

Original languageEnglish
Pages (from-to)299-311
Number of pages13
JournalJournal of Urology
Volume210
Issue number2
DOIs
StatePublished - 1 Aug 2023

Keywords

  • molecular imaging
  • positron-emission tomography
  • prostatic neoplasms

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