Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer

Inclusion Criteria

• 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, and/or [18F]FDG PET
• Rising PSA on two observations taken at least 1 week apart
• Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
• Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
• Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
• 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

• Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
• 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)
• Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
• 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
• Unable to lie flat during or tolerate PET/CT
• Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.