Integrated 18F-labelled PSMA Project

This is an exploratory single centre, non-randomized, open-label, study in male subjects with metastatic, castrate-resistant PCa (CRPC) being treated with a second-line anti-androgen therapy (enzalutamide or abiraterone). The purpose of the study is to assess if 18F-DCFPyL PET/CT: 1. Shows more sites of metastatic, castrate-resistant PCa (CRPC) compared with standard imaging (bone scan and CT) at baseline and follow-up, 2. Shows response to therapy that is associated with clinical outcome. This study will image male subjects with CRPC undergoing second-line anti-androgen therapy (enzalutamide or abiraterone) using 18F-DCFPyL PET/CT for detection of metastases and therapeutic monitoring, with correlation to standard-of-care imaging (CT and bone scan) and clinical follow-up over a 1-year time period. Subjects with CRPC and planned treatment with evidence of metastases on standard-of-care imaging (CT and/or bone scan) will undergo a baseline and mid-therapy 18F-DCFPyL PET/CT. The study design consists of three study clinic visits (screening, baseline 18F-DCFPyL PET/CT, and 8-14 week follow-up 18F-DCFPyL PET/CT) and two follow-up safety phone calls. In addition, all subjects will be followed clinically as per local standard of care with prostate-specific antigen (PSA) blood levels and standard of care imaging for up to one year following the baseline 18F-DCFPyL administration.