FACBC PET/CT for Recurrent Prostate Cancer
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 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 FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called 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.
This study will look at how the FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||18F-FACBC PET-CT for the Detection and Staging of Recurrent Prostate Carcinoma (CA129356-01).|
- We will investigate the ability of anti-[18F]FACBC PET-CT imaging to detect recurrence of prostate carcinoma in the prostate bed validated by pathologic analysis of prostate bed biopsies and patient follow-up. [ Time Frame: At time of scan and pathologic examination and patient follow-up ] [ Designated as safety issue: No ]
- Investigate the ability of anti-[18F]FACBC PET-CT imaging to detect extra-prostatic recurrence of prostate carcinoma validated by pathologic analysis of suspect lymph nodes sampled via percutaneous and laparoscopic methods and patient follow-up. [ Time Frame: At time of scan and pathologic examination and patient follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
This is a single arm study
[18F]FACBC is given intravenously prior to PET scan
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562315
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||David M Schuster, MD||Emory University|