A Safety Study of 18F-DCFPyL, a PSMA-based PET Radiotracer, in Patients With Advanced Prostate Cancer

To assess the hypothesis that this new 2nd generation positron emission tomography (PET)
radiopharmaceutical, 18F-DCFPyL, may possess pharmacokinetic and pharmacodynamic properties
that will represent an advance in imaging metastatic prostate cancer in ten patients
diagnosed with metastatic prostate cancer.

Inclusion Criteria:

- Patients may be enrolled into this protocol only if all of the following inclusion
criteria are met:

1. Greater than or equal to 18 years of age

2. Histological confirmation of prostate cancer

3. Radiologic evidence of new or progressive metastatic disease demonstrated on
anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, 18F-Sodium
Fluoride PET, or 18F-FDG PET

4. PSA ≥ 1.0 ng/mL

5. Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.

6. Platelet count > 50,000/mm3

7. Neutrophil count > 1,000/mm3

8. 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.

9. 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:

- Patients will be excluded from enrollment if any of the following apply:

1. Karnovsky performance status of < 60

2. Inadequate venous access (two antecubital or equivalent venous access sites are
required for study drug injection and PK blood sampling, respectively)

3. Patient received a permanent prostate brachytherapy implant within the last 3
months (for Pd-103 implants) or 12 months (for I-125 implants)

4. Administered a radioisotope within 5 physical half-lives prior to study
enrollment

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

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

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

8. Patient has been treated with an investigational drug, investigational biologic,
or investigational therapeutic device within 30 days prior to study radiotracer
administration

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

10. Prior history of any other malignancy within 3 years, other than skin basal cell
carcinoma.