Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer.

Inclusion Criteria:

1. Histological confirmation of prostate cancer

2. Radiologic evidence of new or progressive metastatic disease demonstrated on
anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, [18F]Sodium Fluoride
PET, and/or [18F]FDG PET

3. Rising PSA on two observations taken at least 1 week apart

4. Adequate peripheral venous access or available central venous catheter access for
radiopharmaceutical administration

5. Patient can remain on androgen deprivation therapy if on the same regimen prior to
documentation of progressive metastatic disease

6. Patient cannot start a new therapy for prostate cancer prior to study
radiopharmaceutical imaging

7. Patient is judged by the Investigator to have the initiative and means to be compliant
with the protocol and be within geographical proximity to make the required study
visits

8. 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:

1. Patient has been treated with an investigational drug, investigational biologic, or
investigational therapeutic device within 14 days prior to study radiotracer
administration

2. Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks
prior to study radiotracer administration (Washout is one half-life of the drug or 2
weeks, whichever is longest)

3. Initiation of new therapy for progressive metastatic disease since radiographic
documentation of progression.

4. Serum creatinine > 3 times the upper limit of normal

5. Total bilirubin > 3 times the upper limit of normal

6. Liver Transaminases > 5times the upper limit of normal

7. Unable to lie flat during or tolerate PET/CT (or PET/MRI imaging if available)

8. Prior history of any other malignancy within last 2 years, other than skin basal cell
carcinoma or superficial bladder cancer.