TheranosticTrials.org

Clinical Trial · NCT00562315

FACBC PET/CT for Recurrent Prostate Cancer

Overview

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.

Sponsor

Emory University

Phase

Phase 2

Contacts

David M Schuster, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00562315

Drug / Compound

FACBC

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

Eligibility

Inclusion

  • 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."
  • 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.
  • 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

Exclusion

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