NCT00562315

FACBC PET/CT for Recurrent Prostate Cancer

18F-FACBC PET-CT for the Detection and Staging of Recurrent Prostate Carcinoma (CA129356-01).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: David M. Schuster, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 \[18\]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 \[18\]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called \[18\]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. Anti-\[18F\]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention. This study will look at how the \[18\]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	FACBC	Anti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan
OTHER	ProstaScinct	ProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging.

Timeline

• Start date: 2007-10-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2007-11-22
• Last updated: 2016-06-21
• Results posted: 2015-08-18

Locations

1 site across 1 country: United States