Pelvic lymph-node staging with18F-DCFPyL PET/CT prior to extended pelvic lymph-node dissection in primary prostate cancer-the SALT trial

Purpose The detection of lymph-node metastases (N1) with conventional imaging such as magnetic resonance imaging (MRI) and computed tomography (CT) is inadequate for primarily diagnosed prostate cancer (PCa). Prostate-specific membrane antigen (PSMA) PET/CT is successfully introduced for the staging of (biochemically) recurrent PCa. Besides the frequently used(68)gallium-labelled PSMA tracers,(18)fluorine-labelled PSMA tracers are available. This study examined the diagnostic accuracy of(18)F-DCFPyL (PSMA) PET/CT for lymph-node staging in primary PCa. Methods This was a prospective, multicentre cohort study. Patients with primary PCa underwent(18)F-DCFPyL PET/CT prior to robot-assisted radical prostatectomy (RARP) with extended pelvic lymph-node dissection (ePLND). Patients were included between October 2017 and January 2020. A Memorial Sloan Kettering Cancer Centre (MSKCC) nomogram risk probability of >= 8% of lymph-node metastases was set to perform ePLND. All images were reviewed by two experienced nuclear physicians, and were compared with post-operative histopathologic results. Results A total of 117 patients was analysed. Lymph-node metastases (N1) were histologically diagnosed in 17/117 patients (14.5%). The sensitivity, specificity, positive predictive value and negative predictive value for the(18)F-DCFPyL PET/CT detection of pelvic lymph-node metastases on a patient level were 41.2% (confidence interval (CI): 19.4-66.5%), 94.0% (CI 86.9-97.5%), 53.8% (CI 26.1-79.6%) and 90.4% (CI 82.6-95.0%), respectively. Conclusion F-18-DCFPyL PET/CT showed a high specificity (94.4%), yet a limited sensitivity (41.2%) for the detection of pelvic lymph-node metastases in primary PCa. This implies that current PSMA PET/CT imaging cannot replace diagnostic ePLND. Further research is necessary to define the exact place of PSMA PET/CT imaging in the primary staging of PCa.

Automated summary

The study found that F-18-DCFPyL PET/CT has high specificity but limited sensitivity for detecting pelvic lymph-node metastases in primary prostate cancer patients. Therefore, current PSMA PET/CT imaging cannot fully replace diagnostic ePLND. Further research is needed to determine the exact role of PSMA PET/CT imaging in the primary staging of prostate cancer.