Prostate-specific membrane antigen (PSMA) demonstrates overexpression in prostate cancer and correlates with tumor aggressiveness. PSMA positron emission tomography (PET) is superior to conventional imaging for the metastatic staging of prostate cancer per current research but studies of second-generation PSMA PET radioligands for locoregional staging are limited.
Objective:
To determine the accuracy of fluorine-18 PSMA-1007 PET/computed tomography (18F-PSMA-1007 PET/CT) compared to multiparametric magnetic resonance imaging (MRI) in the primary locoregional staging of intermediate-risk and high-risk prostate cancers.
Design, Setting, and Participants:
The Next Generation Trial was a phase 2 prospective validating paired cohort study assessing the accuracy of 18F-PSMA-1007 PET/CT and MRI for locoregional staging of prostate cancer, with results of histopathologic examination as the reference standard comparator. Radiologists, nuclear medicine physicians, and pathologists were blinded to preoperative clinical, pathology, and imaging data. Patients underwent all imaging studies and radical prostatectomies at 2 tertiary care hospitals in Alberta, Canada. Eligible participants included men with intermediate-risk or high-risk prostate cancer who consented to radical prostatectomy. Participants who underwent radical prostatectomy were included in the final analysis. Patients were recruited between March 2022 and June 2023, and data analysis occurred between July 2023 and December 2023.
Exposures:
All participants underwent both 18F-PSMA-1007 PET/CT and MRI within 2 weeks of one another and before radical prostatectomy.
Main Outcomes and Measures:
The primary outcome was the correct identification of the prostate cancer tumor stage by each imaging test. The secondary outcomes were correct identification of the dominant nodule, laterality, extracapsular extension, and seminal vesical invasion.
Results:
Of 150 eligible men with prostate cancer, 134 patients ultimately underwent radical prostatectomy (mean [SD] age at prostatectomy, 62.0 [5.7] years). PSMA PET was superior to MRI for the accurate identification of the final pathological tumor stage (61 [45%] vs 38 [28%]; P = .003). PSMA PET was also superior to MRI for the correct identification of the dominant nodule (126 [94%] vs 112 [83%]; P = .01), laterality (86 [64%] vs 60 [44%]; P = .001), and extracapsular extension (100 [75%] vs 84 [63%]; P = .01), but not for seminal vesicle invasion (122 [91%] vs 115 [85%]; P = .07).
Conclusions and Relevance:
In this phase 2 prospective validating paired cohort study, 18F-PSMA-1007 PET/CT was superior to MRI for the locoregional staging of prostate cancer. These findings support PSMA PET in the preoperative workflow of intermediate-risk and high-risk tumors.
Nikhile Mookerji, MD,1 Tyler Pfanner, MD,2 Amaris Hui, MD,2 Guocheng Huang, MD,1 Patrick Albers, MD,1 Rohan Mittal, MD,3 Stacey Broomfield, PhD,1 Lucas Dean, MD,1,4 Blair St. Martin, MD,1,4 Niels-Erik Jacobsen, MD,1,4 Howard Evans, MD,1,4 Yuan Gao, MD,3 Ryan Hung, MD, PhD,2 Jonathan Abele, MD,2 Peter Dromparis, MD, PhD,3 Joema Felipe Lima, MD,5 Tarek Bismar, MD,5,6 Evangelos Michelakis, MD,7 Gopinath Sutendra, PhD,7,8 Frank Wuest, PhD,8,9 Wendy Tu, MD,2 Benjamin A. Adam, MD,3 Christopher Fung, MD,2 Alexander Tamm, MD,2,6 Adam Kinnaird, MD, PhD1,4,6,8,9
- Division of Urology, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada
- Department of Radiology & Diagnostic Imaging, University of Alberta, Edmonton, Alberta, Canada
- Department of Laboratory Medicine & Pathology, University of Alberta, Edmonton, Alberta, Canada
- Alberta Centre for Urologic Research and Excellence (ACURE), Alberta, Canada
- Department of Pathology & Laboratory Medicine, University of Calgary, Calgary, Alberta, Canada
- Alberta Prostate Cancer Research Initiative (APCaRI), Alberta, Canada
- Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
- Cancer Research Institute of Northern Alberta (CRINA), Edmonton, Alberta, Canada
- Department of Oncology, University of Alberta, Edmonton, Alberta, Canada
Fluorine-18 Prostate-Specific Membrane Antigen–1007 PET/CT vs Multiparametric MRI for Locoregional Staging of Prostate Cancer