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

NCT00917865 | Terminated Phase 2 Results DMC

• 2 other identifiers: IRB00008094FACBC
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancers

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis

  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.

  At 4, 16, 28 and 40 minutes post-injection of FACBC

Secondary Outcomes (1)

• Mean SUVmax of Low Versus High Gleason Groups

  4 minutes,16 minutes,28 minutes and 40 minutes

Study Arms (1)

FACBC Imaging

EXPERIMENTAL

Dynamic FACBC PET of primary prostate carcinoma.

Drug: anti [18F]FACBC

Interventions

anti [18F]FACBC DRUG

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.

FACBC Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• David M. Schuster, MD: lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• 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.

  PMID: 23342303 RESULT

Related Links

• Click here for more information on this study

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

A major limitation of our study is lack of step section whole mount histology at our institution which restricted the ability to ensure an exact correlation of histology to imaging.

Results Point of Contact

• Title: David Schuster, MD
• Organization: Emory University

dschust@emory.edu

404-712-4859

Study Officials

• David M Schuster, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 10, 2009
• Study Start: April 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: January 1, 2013
• Last Updated: January 7, 2014
• Results First Posted: January 7, 2014

Record last verified: 2013-11

Locations

US (1)