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

This study has been terminated.
(Optimal histolgic verification support such as whole mount analysis could not be made available.)
Sponsor:
Information provided by (Responsible Party):
David M. Schuster, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00917865
First received: June 5, 2009
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Prostate Cancers
Drug: anti [18F]FACBC
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Anti-[18F]FACBC PET-CT for the Characterization of Primary Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis [ Time Frame: At 4, 16, 28 and 40 minutes post-injection of FACBC ] [ Designated as safety issue: No ]

    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:
  • Mean SUVmax of Low Versus High Gleason Groups [ Time Frame: 4 minutes,16 minutes,28 minutes and 40 minutes ] [ Designated as safety issue: No ]
    To determine id radiotracer uptake correlates with gleason score


Enrollment: 11
Study Start Date: April 2008
Study Completion Date: January 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917865

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

Additional Information:
Publications:
Responsible Party: David M. Schuster, MD, Sponsor-Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00917865     History of Changes
Other Study ID Numbers: IRB00008094, FACBC
Study First Received: June 5, 2009
Results First Received: May 8, 2013
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014