TheranosticTrials.org

Clinical Trial · NCT01808222

FACBC for Recurrent Prostate Cancer

Overview

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.

Sponsor

Emory University

Phase

Phase 2

Contacts

David M Schuster, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01808222

Drug / Compound

FACBC

Isotope(s):
Target(s):
  • Amino Acid Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Ability to lie still for PET scanning
  • 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."
  • 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.
  • 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

Exclusion

  • Bone scan findings characteristic for metastatic prostate carcinoma
  • Does not meet above criteria of suspicious PSA elevation
  • Less than 1 month since any prior prostate biopsy (to decrease false positive uptake from inflammation). \-
  • Less than 1 year since cryotherapy,external beam radiation therapy, or HiFU or 2 years since brachytherapy..
  • Greater than T3 disease in past and/or treated with prostatectomy.
  • Inability to lie still for PET scanning