Study design
DISEASE
This was a prospective, open label, cross-over, comparative study with randomised treatment administration of [External, independent coded, blinded and centralized interpretation of [As part of the routine care practice, enrolled patients received appropriate treatment. Treatment decisions were pragmatic, at the discretion of the referring physician, based on all available clinical information, including local reports of both PET/CT scans and any other imaging findings. For the purpose of the study, patients were followed-up, up to 10 months after the second tracer injection, to provide any results of subsequent biopsies, imaging studies, clinical findings, PSA measurements, and disease management, if performed routinely.Consensus on the disease status was obtained from a multidisciplinary independent board (truth panel), based on the surrogate standard of reference which included all available results. Assessments were made on a per-region and per-patient basis. Additionally, the truth panel assessed the impact of each PET/CT examination on disease restaging and change in treatment intent, by filling in a PM questionnaire.