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

• Greater than or equal to 18 years of age
• Histological confirmation of prostate cancer
• 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
• PSA ≥ 1.0 ng/mL
• Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.
• Platelet count > 50,000/mm3
• Neutrophil count > 1,000/mm3
• 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.
• 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:

• Karnovsky performance status of < 60
• Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
• Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants)
• Administered a radioisotope within 5 physical half-lives prior to study enrollment
• Serum creatinine > 3 times the upper limit of normal
• Total bilirubin > 3 times the upper limit of normal
• Liver Transaminases > 5times the upper limit of normal
• Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 30 days prior to study radiotracer administration
• 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).
• Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma.