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

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate.

2. Subjects provide signed informed consent and confirm that they are able and willing to
comply with all protocol requirements.

Cohort A Only:

- At least high risk prostate cancer defined by NCCN Guidelines Version 3.2016 (clinical
stage ≥T3a or PSA >20 ng/mL or Gleason score ≥8).

- Scheduled or planned radical prostatectomy with PLND.

Cohort B Only: [Enrollment is complete; No longer recruiting subjects]

- Radiologic evidence of local recurrence or new or progressive metastatic disease
demonstrated on anatomical imaging (CT, MRI, or ultrasound), whole-body bone scan
(99m-Tc-MDP or Na-18F) within 4 weeks of enrollment.

- If prior treatment with radiation or ablative therapy, evidence of recurrence outside
the confines of prior treated site(s) is needed.

- Scheduled or planned percutaneous biopsy of at least one amenable lesion.

Exclusion Criteria:

1. Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within
five physical half-lives, or any IV iodinated contrast medium within 24 hours, or any
high density oral contrast medium (oral water contrast is acceptable) within 5 days,
prior to study drug injection.

2. Subjects with any medical condition or other circumstance that, in the opinion of the
investigator, compromise obtaining reliable data, achieving study objectives, or
completion.

Cohort A Only:

- Patients with prior androgen deprivation therapy or any investigational neoadjuvant
agent or intervention

Cohort B Only: [Enrollment is Complete; No longer recruiting subjects]

- Prior radiation or ablative therapy to intended site of biopsy, if within the prostate
bed

- Initiation of new therapy for recurrent and/or progressive metastatic disease since
radiographic documentation of recurrence/progression.