Background: Early and accurate detection of recurrent or metastatic prostate cancer remains an unmet diagnostic need for patient management. While agents for positron emission tomography (PET), such as ¹¹C-choline and ¹⁸F-fluciclovine, have emerged as options for imaging recurrent prostate cancer, these agents are not specific for the disease. ¹⁸F-DCFPyL is a novel, low-molecular weight, PET radiopharmaceutical that binds selectively to prostate-specific membrane antigen with high affinity. In prior studies, ¹⁸F-DCFPyL PET/CT has shown reliable diagnostic performance in detecting metastatic or recurrent prostate cancer (Rowe Mol Imaging Biol 2016 18:411-19; Gorin J Urol 2018 1999:126-32). Methods: CONDOR is a phase 3, multicenter, open-label study designed to assess the diagnostic performance and clinical impact of ¹⁸F-DCFPyL PET/CT in men with suspected recurrent or metastatic prostate cancer. Approximately 200 patients are planned to be enrolled across 15 centers in the United States and Canada. Eligible patients ≥18 years of age must have histologically confirmed prostate adenocarcinoma, have rising PSA after definitive therapy, and negative or equivocal conventional imaging. A single 9 mCi (333 MBq) dose of ¹⁸F-DCFPyL is administered, followed by whole body PET/CT scan 1 hour later. The primary objective is to assess the correct localization rate (percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on ¹⁸F-DCFPyL PET/CT and the composite truth standard, defined as either evaluable histopathology, informative correlative imaging, or PSA response after radiation therapy). Additional study objectives include safety and tolerability of ¹⁸F-DCFPyL, impact on intended treatment plans, detection rates and PPV of ¹⁸F-DCFPyL by region, and detection rates by baseline PSA. ¹⁸F-DCFPyL PET/CT results are centrally reviewed by independent readers blinded to all clinical and other imaging information. As of February 9, 2019, a total of 36 patients have been dosed in the study. Clinical trial information: NCT03739684