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

Prostate Cancers Clinical Trial

Official title:

Anti-[18F]FACBC PET-CT for the Characterization of Primary Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00917865
• Other study ID #: IRB00008094
• Secondary ID: FACBC
• Status: Terminated
• Phase: Phase 2
• First received: June 5, 2009
• Last updated: November 18, 2013
• Start date: April 2008
• Est. completion date: January 2013

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancers
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
David M. Schuster, MD

Country where clinical trial is conducted

United States, 

References & 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean SUVmax of Low Versus High Gleason Groups	To determine id radiotracer uptake correlates with gleason score	4 minutes,16 minutes,28 minutes and 40 minutes	No

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