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NCT04134208 · ClinicalTrials.gov registry record · Phase 4
An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer
A Phase 4 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT04134208: Clinical Trial Phase 4 study, sponsored by M.D. Anderson Cancer Center.
NCT04134208 is a Phase 4 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 2 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04134208, a Phase 4 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study Summary
This phase IV trial studies how well an investigational scan (18F-fluciclovine PET-CT) works for the measurement of therapeutic response in patients with prostate cancer that has spread to other places in the body (metastatic). 18F-fluciclovine is a radioactive substance that is used in this study with PET-CT imaging scans that may help doctors learn about response to standard therapy in patients with prostate cancer.
Primary Outcome
Will evaluate metabolic response by 18F-fluciclovine PET qualitatively and semi-quantitatively with SUV and correlate the findings with size changes as defined by conventional imaging prostate specific antigen (PSA) response. The percentage of change in the 18F-fluciclovine maximum standardized uptake value (SUVmax) after therapy will be calculated as follows (\[pretreatment corrected SUVmax - posttreatment corrected SUVmax\]/pretreatment corrected SUVmax) x 100. Similar calculations will be per
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- DRUG Fluciclovine F18
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-09-19 |
| Est. Completion | 2022-06-28 |
| Phase | Phase 4 |
Why NCT04134208 stopped before completion
NCT04134208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which Computed Tomography is the first listed.
NCT04134208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04134208 about?
NCT04134208 is a clinical study titled "An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer". This phase IV trial studies how well an investigational scan (18F-fluciclovine PET-CT) works for the measurement of therapeutic response in patients with prostate cancer that has spread to other places in the body (metastatic). 18F-fluciclovine is a radioactive substance that is used in this study w...
What is the current status of trial NCT04134208?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2019-09-19. Estimated completion is 2022-06-28.
What interventions are being tested in trial NCT04134208?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Fluciclovine F18 (DRUG).
Who is sponsoring clinical trial NCT04134208?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04134208's enrollment target sits among peer trials
2 1998th of 2000 higher than 1 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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