CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 221 enrolled
Drug / intervention
18F-fluciclovine PET CTdrug
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/NCT02680041
NCT02680041Phase 3Completed

The Impact of 18F Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on Management of Patients With Rising PSA (Prostate-specific Antigen) After Initial Prostate Cancer Treatment

Blue Earth Diagnostics·interventional·Posted Feb 11, 2016·Updated Jan 28, 2019

In Brief

A Phase 3 clinical trial evaluating 18F-fluciclovine PET CT for Prostate Cancer. Completed, enrolled 221 participants across 17 sites.

Detailed Summary

This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.

Study Details

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

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 11, 2016
Enrollment StartJun 1, 2016
Primary CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.4 years ago

Interventions

18F-fluciclovine PET CTdrug

Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment