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NCT03762759 · ClinicalTrials.gov registry record · Phase 2
Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes
A Phase 2 study of Prostate Adenocarcinoma, sponsored by Emory University.
- Active
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 3
- Study locations
NCT03762759: Active Phase 2 study of Prostate Adenocarcinoma, sponsored by Emory University.
NCT03762759 is a Phase 2 study of Prostate Adenocarcinoma that is active but no longer recruiting, run by Emory University. The registered enrollment target is 140 participants, below the 217-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (35% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03762759, a Phase 2 study of Prostate Adenocarcinoma, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial studies how well a positron emission tomography (PET)/computed tomography (CT) scan using fluciclovine F18 compared with a PET/CT scan with 68Ga-PSMA works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma. Fluciclovine F18 and 68Ga-PSMA are types of tracers, called radiotracers, that are injected and can accumulate in tumor cells to develop images of them during a PET/CT scan. It is not yet known whether giving fluciclovine F18 or 68Ga-PSMA may work better in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.
Primary Outcome
A survival analysis will be conducted on disease-free survival (DFS). The survivor functions for DFS will be estimated with Kaplan and Meier method and plotted. The logrank test will be used to test the difference in DFS of (a) both arms in aggregate with the survivor function on our prior R01 trial and (b) between the two study arms.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- DRUG Fluciclovine F18
- RADIATION Gallium Ga68-labeled PSMA-11
Study Locations (3)
Georgia
- Grady Health System - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2019-05-10 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03762759 still lists
NCT03762759 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 217-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Computed Tomography is the first listed.
NCT03762759 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT03762759 about?
NCT03762759 is a clinical study titled "Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes". This phase II trial studies how well a positron emission tomography (PET)/computed tomography (CT) scan using fluciclovine F18 compared with a PET/CT scan with 68Ga-PSMA works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma. Fluciclovine F18 and 68Ga-...
What is the current status of trial NCT03762759?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2019-05-10. Estimated completion is 2025-12-31.
What conditions does trial NCT03762759 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma.
What interventions are being tested in trial NCT03762759?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Fluciclovine F18 (DRUG), Gallium Ga68-labeled PSMA-11 (RADIATION).
Who is sponsoring clinical trial NCT03762759?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03762759 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03762759's enrollment target sits among peer trials
140 28th of 99 higher than 72 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma 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.
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