Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer

The investigators will image patients with widely metastatic castration-sensitive (CSPC) or
castration-resistant prostate cancer (CRPC) using 18F-DCFPyL-PET/CT for detection of tumor
burden and perform a lesion-based head-to-head comparison with a subsequent near-term (one to
seven days) 18F-DCFPyL-PET/CT follow-up scan, to assess test-retest reproducibility of this
second-generation PSMA-targeted compound. Second, as it has not been specifically
investigated with this compound before, intra-observer agreement as well as inter-scan
variability will be assessed.

Inclusion Criteria:

- Willing and able to provide written informed consent

- History of histologically or cytologically confirmed adenocarcinoma of the prostate
without neuroendocrine differentiation or small cell histology

- Patients with metastatic castration-sensitive (CSPC) or castration-resistant prostate
cancer (CRPC) with evidence of metastatic disease on conventional imaging with CT or
bone scan.

- Prior docetaxel-based chemotherapy is permitted

- Documented metastatic prostate cancer progression as assessed by the treating
oncologist with either one or both of the following and has not initiated a new
therapy after determination of progression: Rising PSA over a minimum 1-week interval
and/or radiographic progression in soft tissue and bone metastases (combination of
bony and soft tissue metastases)

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria:

- Serious or uncontrolled co-existent non-malignant disease, including active and
uncontrolled infection

- Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT

- Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT

- Administered oral contrast medium ≤120 hours prior to the date of study PET/CT

- Condition or situation which, in the investigator's opinion, may put the patient at
significant risk, may confound the study results, or may interfere significantly with
patient's participation in the study