Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer

Inclusion Criteria:

- Histological confirmation of prostate cancer

- Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH
antagonists or bilateral orchiectomy of any duration.

- Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation
of any type or both)

- Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and
pelvis within 6 weeks of 18F-DCFPyL PET/CT

- Treatment with ADT with or without a second line novel AR targeted treatment
(abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first
generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more
permitted) for ≥ 12 months.

- Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart)

- PSADT ≤ 9 months

- Cohort B: mCRPC

- Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥
6 months and/or 4 weeks after discontinuation of first generation antiandrogen
(bicalutamide , flutamide, nilutamide- one or more permitted).

- PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT

- Patients enrolled in other clinical trials are eligible if they satisfy all other
criteria of eligibility.

- No new therapeutic interventions planned or scheduled to be instituted prior to the
course of this study both on cohorts A and B before conventional radiologic
progression is evidenced.

- Patients or their legal representatives must have the ability to read, understand and
provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

- Patient will be excluded from enrollment if he had a radioisotope within 5 physical
half-lives prior to PET imaging