TY - JOUR T1 - Histologically Confirmed Diagnostic Efficacy of <sup>18</sup>F-rhPSMA-7 PET for N-Staging of Patients with Primary High-Risk Prostate Cancer JF - Journal of Nuclear Medicine JO - J Nucl Med SP - 710 LP - 715 DO - 10.2967/jnumed.119.234906 VL - 61 IS - 5 AU - Markus Kroenke AU - Alexander Wurzer AU - Kristina Schwamborn AU - Lena Ulbrich AU - Lena Jooß AU - Tobias Maurer AU - Thomas Horn AU - Isabel Rauscher AU - Bernhard Haller AU - Michael Herz AU - Hans-Jürgen Wester AU - Wolfgang A. Weber AU - Matthias Eiber Y1 - 2020/05/01 UR - http://jnm.snmjournals.org/content/61/5/710.abstract N2 - 18F-rhPSMA-7 (radiohybrid prostate-specific membrane antigen [PSMA]) is a novel ligand for PET imaging. Here, we present data from a retrospective analysis using PET/CT and PET/MRI examinations to investigate the efficacy of 18F-rhPSMA-7 PET for primary N-staging of patients with prostate cancer (PC) compared with morphologic imaging (CT or MRI) and validated by histopathology. Methods: Data from 58 patients with high-risk PC (according to the D’Amico criteria) who were staged with 18F-rhPSMA-7 PET/CT or PET/MRI at our institution between July 2017 and June 2018 were reviewed. The patients had a median prescan prostate-specific antigen value of 12.2 ng/mL (range, 1.2–81.6 ng/mL). The median injected activity of 18F-rhPSMA-7 was 327 MBq (range, 132–410 MBq), with a median uptake time of 79.5 min (range, 60–153 min). All patients underwent subsequent radical prostatectomy and extended pelvic lymph node dissection. The presence of lymph node metastases was determined by an experienced reader independently for both the PET and the morphologic datasets using a template-based analysis on a 5-point scale. Patient-level and template-based results were both compared with histopathologic findings. Results: Lymph node metastases were present in 18 patients (31.0%) and were located in 52 of 375 templates (13.9%). Receiver-operating-characteristic analyses showed 18F-rhPSMA-7 PET to perform significantly better than morphologic imaging on both patient-based and template-based analyses (areas under curve, 0.858 vs. 0.649 [P = 0.012] and 0.765 vs. 0.589 [P &lt; 0.001], respectively). On patient-based analyses, the sensitivity, specificity, and accuracy of 18F-rhPSMA-7 PET were 72.2%, 92.5%, and 86.2%, respectively, and those of morphologic imaging were 50.0%, 72.5%, and 65.5%, respectively. On template-based analyses, the sensitivity, specificity, and accuracy of 18F-rhPSMA-7 PET were 53.8%, 96.9%, and 90.9%, respectively, and those of morphologic imaging were 9.6%, 95.0%, and 83.2%, respectively. Conclusion: 18F-rhPSMA-7 PET is superior to morphologic imaging for N-staging of high-risk primary PC. The efficacy of 18F-rhPSMA-7 is similar to published data for 68Ga-PSMA-11. ER -