This is a single-center, multi-arm, open-label, phase III trial in up to 500 patients with
biopsy-proven prostate cancer.
Participants will receive regular standard of clinical care. The only study-specific
procedures will the administration of 68Ga-PSMA-11 followed by a PET/CT (positron emission
tomography/computed tomography) scan. Participants will be followed for two hours after the
infusion for identification of any immediate adverse events (AE), and will be contacted by
telephone after 7 to 14 days to enquire about any delayed AEs.
PET/CT images, CT-alone images and bone scans will be read by separate readers who will not
be blinded to all other clinical and imaging information. The standard of truth will be a
consensus of the readers based on all available clinical, imaging, and histopathological
information available for up to 6 months after the PET/CT scan.