F-18 Sodium Fluoride in Prostate Cancer
Condition: Prostate Neoplasm
MeSH terms: Prostatic Neoplasms
Intervention: F-18 NaF
Intervention description: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Imaging; Bone Metastasis; Bone Scan; Radiopharmaceutical; Pet Scan; Prostate Cancer

Summary:

      Background:

      - Sodium fluoride (NaF) is a common compound that is found in various foods and can be used
      to increase bone strength. When this compound is added to a small dose of radiation (F-18),
      it collects in the bones, with higher amounts in areas where the bone is rapidly changing,
      such as the site of a healing fracture or a tumor. By giving F-18 NaF before a combined
      positron emission tomography/ computed tomography (PET/CT) scan, researchers hope to be able
      to better measure the changes in the bone that may indicate that a certain type of cancer
      (such as prostate cancer) has spread to the bones.

      Objectives:

        -  To evaluate the effectiveness of F-18 NaF in imaging studies to measure bone tumors and
           their change over time and compare with clinical course, in individuals with prostate
           cancer.

        -  To determine the smallest amount of change in the bone tumors that F-18 NaF can
           accurately measure.

      Eligibility:

      - Men at least 18 years of age who have been diagnosed with prostate cancer and have had
      imaging studies to determine whether the cancer has spread to their bones. Both patients with
      and without known bone involvement will be enrolled.

      Design:

        -  Participants will be screened with a physical examination, medical history, and imaging
           studies, and will provide baseline blood samples to evaluate kidney function.

        -  For the study, participants will have two F-18 NaF PET/CT scans on separate days for
           baseline. These repeat scans will be used to determine the amount of change that is due
           to the imaging process alone (i.e. not due to the disease getting better or worse.
           Participants will receive a dose of F-18 NaF intravenously, and will have PET/CT
           scanning over the body (mid ear to upper thighs) over 1 hour, the body followed by a
           complete whole-body PET/CT scan at approximately 2 hours after F-18 NaF injection.
           Participants will be watched closely for side effects from the F-18 NaF until the scans
           are done, and will be asked to drink plenty of water to void the F-18 NaF from the body
           after the scans.

        -  As a followup study, participants will have two more F-18 NaF PET/CT scans, one 4 to 8
           months after the first scans and then one 10 to 14 months after the first scans.
           Participants will provide additional blood samples before the followup scans.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Participants must have a clinical course consistent with prostate cancer and have available
        documentation of prostate adenocarcinoma from either the National Cancer Institute (NCI) or
        from an outside pathology laboratory.

        Participant must have:

        - A history of PSA of > 10ng/mL or a history of PSA doubling time of less than or equal to
        6 months, and no known bone metastatic involvement on standard of care imaging (Tc-99m MDP
        bone scan, CT etc)

        OR

        - Any PSA level and known bone metastatic disease on standard of care imaging (Tc-99m MDP
        bone scan, CT etc).

        Ability to provide informed consent. All subjects must sign a document of informed consent
        indicating their understanding of the investigational nature and risks of the study before
        any protocol related studies are performed.

        EXCLUSION CRITERIA:

        Participants with severe claustrophobia unresponsive to oral anxiolytics.

        Subjects weighing greater than 350 lbs (weight limit for scanner table), or unable to fit
        within the imaging gantry.

        Subjects with any medical condition or other circumstances that, in the opinion of the
        Investigator, would significantly decrease obtaining reliable data, achieving study
        objectives or completing the study.