FACBC PET/CT for Recurrent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: FACBC; ProstaScinct
Intervention description: Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan; ProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 128.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence,
      and lead to better characterization of disease status in restaging patients.

      This is a study that will test a compound (chemical substance) that has a small amount of
      radioactivity attached to it. This substance has a natural tendency to go to prostate tissue.
      The substance is called [18]FACBC and it is given in the form of an injection into a vein.
      After the substance reaches the prostate, scans called PET or Positron Emission Tomography,
      are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is
      used for PET scans but this substance is eliminated by the kidneys and cannot reach the
      prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow
      tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on
      the prostate is cancer with scans or x-rays that are usually done.

      Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the
      conventional imaging for prostate cancer. Investigators will be blinded of the intervention.

      This study will look at how the [18]FACBC goes into the prostate tissue and determine its
      ability to detect recurrent prostate cancer.
    

Eligibility criteria:

        STUDY NOW CLOSED for recruitment

        Inclusion Criteria:

          -  Patients must be 18 years of age or older.

          -  Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 )
             prostate carcinoma and have undergone what was considered definitive therapy for
             localized disease.

          -  In the case of brachytherapy, cryotherapy, or external beam radiation, treatment will
             have occurred at least 2 years in the past to eliminate patients with so-called "PSA
             bump."

          -  Patient will have suspicion of recurrent prostate carcinoma as defined by: ASTRO
             criteria of three consecutive rises of PSA or earlier if clinically appropriate,
             and/or nadir + 2.0 after radiotherapy, and/or greater than 0.3 after prostatectomy.

          -  Ability to lie still for PET scanning

          -  Patients must be able to provide written informed consent.

        Exclusion Criteria:

          -  Age less than 18.

          -  Greater than T3 disease in past

          -  Prior prostatectomy or 2 years since brachytherapy, cryotherapy, or external beam
             radiation therapy.

          -  Does not meet above criteria of suspicious PSA elevation

          -  Inability to lie still for PET scanning

          -  Cannot provide written informed consent.

          -  Bone scan findings characteristic for metastatic prostate carcinoma

          -  Less than 2 months since any prior prostate biopsy (to decrease false positive uptake
             from inflammation).