Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer

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.