FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00917865
Recruitment Status : Terminated (Optimal histolgic verification support such as whole mount analysis could not be made available.)
First Posted : June 10, 2009
Results First Posted : January 7, 2014
Last Update Posted : January 7, 2014
Information provided by (Responsible Party):
David M. Schuster, MD, Emory University

Brief Summary:

The purpose of this research project is to test if a compound (chemical substance) has a natural tendency to go to prostate cancer. This compound has a small amount of radioactivity attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be detected on a special imaging device called a PET scanner (positron emission tomography). The radiotracer is treated in the body much like an amino acid which is a nutrient required for normal functioning. Tumors also use these nutrients. Earlier studies have shown that this radiotracer may be able to detect prostate cancer.

The investigators will perform a study with 20 patients in whom they know have prostate cancer after a biopsy and who are scheduled for an operation in which the prostate is removed and the nearby lymph nodes are examined. This operation is called prostatectomy. The investigators think that this radiotracer can help us determine where exactly the prostate cancer is present in the prostate or if it has spread. This information may be useful in the future to help with other non-surgical therapy such as radiation beam therapy.

The investigators will compare the results of the FACBC PET scan to the results of the pathology analysis of the removed prostate. In this way the investigators can determine how good a test FACBC PET is for finding out where and if prostate cancer is located in the prostate or nearby lymph nodes. The investigators will also do more advanced analysis on the biopsy samples to see if they can tell why FACBC goes into prostate cancer cells.

This radiotracer has been tested in over 100 human subjects without incident. It has also been chosen by the National Institutes of Health (NIH) as a promising radiotracer. The NIH is funding this study.

Condition or disease Intervention/treatment Phase
Prostate Cancers Drug: anti [18F]FACBC Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Anti-[18F]FACBC PET-CT for the Characterization of Primary Prostate Cancer
Study Start Date : April 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: FACBC Imaging
Dynamic FACBC PET of primary prostate carcinoma.
Drug: anti [18F]FACBC
Anti[18F]FACBC (10mci) will be given intravenously over 1-2 minutes prior to obtaining PET-CT images At 4 minutes, 10 consecutive/4minutes images will be obtained of the pelvis to include the prostate.

Primary Outcome Measures :
  1. Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis [ Time Frame: At 4, 16, 28 and 40 minutes post-injection of FACBC ]

    Each of 12 sextants per prostate (for a total of 120 sextants for the 10 patients) were analyzed separately at 4, 16, 28 and 40 min post-injection for the presence or absence of focal activity suspicious for tumor.

    Sensitivity: Proportion of people with a disease who have a positive test result

    Specificity: The proportion of people without disease who have a negative test result Positive Predictive Value (PPV):The probability that a person who has a positive test result has the disease for which the test was conducted.

    Negative Predictive Value (NPV): The probability that a person who has a negative test result does not have the disease for which the test was conducted

    Accuracy: Ability of the test to differentiate between disease and non-disease.

    Note: 'n=' is the denominator used to compute each parameter.

Secondary Outcome Measures :
  1. Mean SUVmax of Low Versus High Gleason Groups [ Time Frame: 4 minutes,16 minutes,28 minutes and 40 minutes ]
    To determine id radiotracer uptake correlates with gleason score

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must be 18 years of age or older.
  • Patients will be scheduled for prostatectomy based on a diagnosis of primary prostate cancer.
  • Ability to lie still for PET scanning
  • Patients must be able to provide written informed consent.

Exclusion Criteria:

  • Age less than 18
  • Inability to lie still for PET scanning
  • Cannot provide written informed consent.
  • Less than 4 weeks since any prior prostate biopsy (to decrease false positive uptake from inflammation).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00917865

United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
David M. Schuster, MD
Principal Investigator: David M Schuster, MD Emory University

Additional Information:
Publications of Results:
Responsible Party: David M. Schuster, MD, Sponsor-Investigator, Emory University Identifier: NCT00917865     History of Changes
Other Study ID Numbers: IRB00008094
FACBC ( Other Identifier: Other )
First Posted: June 10, 2009    Key Record Dates
Results First Posted: January 7, 2014
Last Update Posted: January 7, 2014
Last Verified: November 2013

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases