This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).
Male, at least 18 years old.
Prostate biopsy naïve.
Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines.
Have the capacity to understand the study and be able and willing to comply with all protocol requirements.
Has prior diagnosis of csPCa
Previous diagnosis of cancer of any primary origin (excluding basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy).
Telix Pharmaceuticals (Innovations) Pty Limited
Lead sponsor
Telix Innovations S.A.
Collaborator