CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 165 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/NCT01666808
NCT01666808Phase 3Completed

Advanced Molecular Imaging With Anti-3-[18F]FACBC PET-CT to Improve the Selection and Outcomes of Prostate Cancer Patients Receiving Post-prostatectomy Radiotherapy

Emory University·interventional·Posted Aug 16, 2012·Updated Aug 2, 2023

In Brief

A Phase 3 clinical trial evaluating FACBC and Radiation therapy for Prostate Cancer. Completed, enrolled 165 participants across 1 site.

Detailed Summary

Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy decision and volumes guided by the FACBC test (anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (anti-3- \[18F\]FACBC). The major goal of the investigation is to see whether the FACBC improves the selection and the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.

Study Details

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

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 16, 2012
Enrollment StartSep 1, 2012
Primary CompletionApr 18, 2022
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 13.9 years ago

Interventions

FACBCdrug

FACBC is given intravenously prior to PET scan, radiotherapy decisions and treatment guided by PET findings

Radiation therapyradiation

External beam radiotherapy to prostate bed +/- pelvic lymph nodes; final dose of 66.6 Gy.