FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer
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.
|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|
- We will investigate the ability of anti[18F]FACBC to detect primary prostate carcinoma, and to detect the primary transport mechanism for its uptake [ Time Frame: At time of scan ] [ Designated as safety issue: No ]
- To determine the feasibility of utilizing the uptake of anti-[18F]ACBC with fusion to anatomic MRI images of the prostate to plan intensity modulated radiotherapy (IMRT) [ Time Frame: At end of accrual. Will software fuse the 20 patient studies. ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||January 2013|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
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.