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

The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor
of prostate-specific membrane antigen (PSMA), [18F]DCFBC (DCFBC) PET imaging for detection of
metastatic prostate cancer. PSMA is a well characterized histological marker of prostate
cancer tumor aggressiveness and metastatic potential. The investigators propose to assess the
ability of DCFBC PET to detect metastatic prostate cancer by visual qualitative and
quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease
detected by standard conventional imaging modalities (CIM) for prostate cancer which includes
IV contrast CT of chest/abdomen/pelvis and whole body bone scintigraphy.

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

8. 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.