A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer

This is a Phase II, diagnostic imaging, controlled, open-label, single site study in four cohorts of patients with known or suspected metastatic prostate cancer. All participants will be imaged with \[18\]F-PSMA-1007 PET/CT; \[18\]F-PSMA-1007 PET/MRI may be performed instead of a PET/CT, if PET/MRI is available. The patients will be assessed for AEs after administration of \[18\]F-PSMA-1007, during their visit to the Nuclear Medicine Department. The assessment of impact on patient management will be performed using a questionnaire both before and after the \[18\]F-PSMA-1007 PET/CT or PET/MRI scan. The efficacy evaluation will consist of \[18\]F-PSMA-1007 PET/CT or PET/MRI clinical accuracy compared to standard of care CT and bone scan. Standard gadolinium-based contrast enhanced PET/MRI imaging may be performed if clinically indicated and if there are no contraindications. If a PET/MRI is performed, the clinical accuracy of the MRI component of the PET/MRI will be compared to the baseline CT. \[18\]F-PSMA-1007 uptake (SUVmax, Uptake Score) will be assessed in a selection of lesions and compared to PSA values collected on the day of the scan and Gleason score collected from the participant's medical history.