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Completed Phase 3 Interventional Results available

18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment

ClinicalTrials.gov ID: NCT02680041

Public ClinicalTrials.gov record NCT02680041. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 10:36 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02680041
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Blue Earth Diagnostics
Industry
Enrollment
221 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 1, 2016 (Actual)
Primary completion
Nov 1, 2017 (Actual)
Completion
Nov 1, 2017 (Actual)
Last update posted
Jan 28, 2019

2016 – 2017

United States locations

U.S. sites
17
U.S. states
10
U.S. cities
13
Facility City State ZIP Site status
City of Hope National Medical Center Duarte California 91010 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
Tower Urology Los Angeles California 90048 —
Genesis Research, LLC San Diego California 92123 —
University of Florida Jacksonville Florida 32209 —
Loyola University Medical Center Maywood Illinois 60153 —
Roudebush VA Medical Center Indianapolis Indiana 46202 —
University of Louisville Louisville Kentucky 40202 —
Washington University School of Medicine St Louis Missouri 63110 —
Coastal Urology Associates Brick New Jersey 08724 —
Manhattan Medical Research New York New York 10016 —
Icahn School of Medicine at Mount Sinai New York New York 10029 —
Urologic Consultants of SE Pennsylvania Bala-Cynwyd Pennsylvania 19004 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107 —
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 —
University of Utah, Huntsman Cancer Institute Salt Lake City Utah 84112 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02680041, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 28, 2019 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02680041 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →