FACBC for Recurrent Prostate Cancer
Condition: Recurrent Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: FACBC
Intervention description: Participants will receive a bolus of anti-[18F]FACBC injected IV over 1-2 minutes. The dosage will be approximately 10.0 millicuries (mCi) (3.70 x 108 becquerel (Bq)).
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators will perform a study with 25 patients in whom the investigators have a
      strong suspicion of prostate cancer that has returned to the body after having an initial
      treatment. The major goal of the investigation is to see whether anti-[18F] FACBC PET-CT and
      MRI imaging individually will be useful in the detection of local and extraprostatic
      recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan
      and one week later as required by the FDA. All patients will undergo biopsy of the prostate
      as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate
      cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically
      appropriate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must be 18 years of age or older.

          2. Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 )
             prostate carcinoma and have undergone what was considered definitive non-prostatectomy
             therapy for localized disease.

          3. In the case of cryotherapy, external beam radiation, or High-Intensity Focused
             Ultrasound (HiFU) the procedure will have occurred at least one year in the past. In
             the case of brachytherapy, treatment will have occurred at least 2 years in the past
             to eliminate patients with so-called "PSA bump."

          4. Patient will have suspicion of recurrent prostate carcinoma as defined by: the
             Radiation Therapy Oncology Group (RTOG) - American Society for Therapeutic Radiology
             and Oncology (ASTRO) Phoenix criteria of nadir PSA +2, and absolute PSA ≥ 4.0
             ng/ml.with any doubling time (DT) or with PSA 2.0-3.99 ng/ml with DT ≤10 months

          5. Ability to lie still for PET scanning

          6. Patients must be able to provide written informed consent.

        Exclusion Criteria:

          1. Age less than 18.

          2. Greater than T3 disease in past and/or treated with prostatectomy.

          3. Less than 1 year since cryotherapy,external beam radiation therapy, or HiFU or 2 years
             since brachytherapy..

          4. Does not meet above criteria of suspicious PSA elevation

          5. Inability to lie still for PET scanning

          6. Cannot provide written informed consent.

          7. Bone scan findings characteristic for metastatic prostate carcinoma

          8. Less than 1 month since any prior prostate biopsy (to decrease false positive uptake
             from inflammation).

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