Clinical trial NCT00917865: FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer
Official title: Anti-[18F]FACBC PET-CT for the Characterization of Primary Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancers
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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).

Primary outcomes:
measure: Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis
timeFrame: At 4, 16, 28 and 40 minutes post-injection of FACBC
Secondary outcomes:
measure: Mean SUVmax of Low Versus High Gleason Groups
timeFrame: 4 minutes,16 minutes,28 minutes and 40 minutes
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: David M Schuster, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schuster DM, Taleghani PA, Nieh PT, Master VA, Amzat R, Savir-Baruch B, Halkar RK, Fox T, Osunkoya AO, Moreno CS, Nye JA, Yu W, Fei B, Wang Z, Chen Z, Goodman MM. Characterization of primary prostate carcinoma by anti-1-amino-2-[(18)F] -fluorocyclobutane-1-carboxylic acid (anti-3-[(18)F] FACBC) uptake. Am J Nucl Med Mol Imaging. 2013;3(1):85-96. Epub 2013 Jan 5.