FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer
Condition: Prostate Cancers
MeSH terms: Prostatic Neoplasms
Intervention: anti [18F]FACBC
Intervention description: Anti[18F]FACBC (10mci) will be given intravenously over 1-2 minutes prior to obtaining PET-CT images At 4 minutes, 10 consecutive/4minutes images will be obtained of the pelvis to include the prostate.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research project is to test if a compound (chemical substance) has a
      natural tendency to go to prostate cancer. This compound has a small amount of radioactivity
      attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be
      detected on a special imaging device called a PET scanner (positron emission tomography). The
      radiotracer is treated in the body much like an amino acid which is a nutrient required for
      normal functioning. Tumors also use these nutrients. Earlier studies have shown that this
      radiotracer may be able to detect prostate cancer.

      The investigators will perform a study with 20 patients in whom they know have prostate
      cancer after a biopsy and who are scheduled for an operation in which the prostate is removed
      and the nearby lymph nodes are examined. This operation is called prostatectomy. The
      investigators think that this radiotracer can help us determine where exactly the prostate
      cancer is present in the prostate or if it has spread. This information may be useful in the
      future to help with other non-surgical therapy such as radiation beam therapy.

      The investigators will compare the results of the FACBC PET scan to the results of the
      pathology analysis of the removed prostate. In this way the investigators can determine how
      good a test FACBC PET is for finding out where and if prostate cancer is located in the
      prostate or nearby lymph nodes. The investigators will also do more advanced analysis on the
      biopsy samples to see if they can tell why FACBC goes into prostate cancer cells.

      This radiotracer has been tested in over 100 human subjects without incident. It has also
      been chosen by the National Institutes of Health (NIH) as a promising radiotracer. The NIH is
      funding this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be 18 years of age or older.

          -  Patients will be scheduled for prostatectomy based on a diagnosis of primary prostate
             cancer.

          -  Ability to lie still for PET scanning

          -  Patients must be able to provide written informed consent.

        Exclusion Criteria:

          -  Age less than 18

          -  Inability to lie still for PET scanning

          -  Cannot provide written informed consent.

          -  Less than 4 weeks since any prior prostate biopsy (to decrease false positive uptake
             from inflammation).