CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 128 enrolled
Drug / intervention
FACBC +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00562315
NCT00562315Phase 2Completed

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

David M. Schuster, MD·interventional·Posted Nov 22, 2007·Updated Jun 21, 2016

In Brief

A Phase 2 clinical trial evaluating FACBC and ProstaScinct for Prostate Cancer. Completed, enrolled 128 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 22, 2007
Enrollment StartOct 1, 2007
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 18.6 years ago

Interventions

FACBCdrug

Anti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan

ProstaScinctother

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.