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NCT02680041 · ClinicalTrials.gov registry record · Phase 3
18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
A Phase 3 study, sponsored by Blue Earth Diagnostics.
- Completed
- Registry status
- Phase 3
- Development phase
- 221
- Enrollment target
NCT02680041: Completed Phase 3 study, sponsored by Blue Earth Diagnostics.
NCT02680041 is a Phase 3 study that has completed, run by Blue Earth Diagnostics. The registered enrollment target is 221 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02680041, a Phase 3 study, has completed, sponsored by Blue Earth Diagnostics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 221 participants
- Enrollment target
Study 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.
Primary Outcome
The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT
Interventions
- DRUG 18F-fluciclovine PET CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2016-06-01 |
| Est. Completion | 2017-11-01 |
| Phase | Phase 3 |
What the finished NCT02680041 record still lists
NCT02680041 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which 18F-fluciclovine PET CT is the first listed.
NCT02680041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02680041 about?
NCT02680041 is a clinical study titled "18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment". 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...
What is the current status of trial NCT02680041?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 221 participants. The study started on 2016-06-01. Estimated completion is 2017-11-01.
What interventions are being tested in trial NCT02680041?
The interventions under investigation include: 18F-fluciclovine PET CT (DRUG).
Who is sponsoring clinical trial NCT02680041?
This trial is sponsored by Blue Earth Diagnostics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02680041's enrollment target sits among peer trials
221 1318th of 2000 higher than 683 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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