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NCT03515577 · ClinicalTrials.gov registry record · Phase 2
Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery
A Phase 2 study of Recurrent Prostate Carcinoma, sponsored by Jonsson Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03515577: Completed Phase 2 study of Recurrent Prostate Carcinoma, sponsored by Jonsson Comprehensive Cancer Center.
NCT03515577 is a Phase 2 study of Recurrent Prostate Carcinoma that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 50 participants, below the 164-participant average among 29 other Recurrent Prostate Carcinoma trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03515577, a Phase 2 study of Recurrent Prostate Carcinoma, has completed, sponsored by Jonsson Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial compares how well gallium 68-labeled PSMA-11 positron emission tomography/computed tomography (PET/CT) works compared to fluciclovine F18 PET/CT in imaging participants with prostate cancer after surgery that has come back. PET is an established imaging technique that uses small amounts of radioactivity and CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. Diagnostic procedures, such as PET/CT with gallium 68-labeled PSMA-11, may work better than PET/CT with fluciclovine F18 in helping find out how far the prostate cancer has spread.
Primary Outcome
Will compare rates for the identification of tumor location(s), assessed by patient and region based analysis. This will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using the Wilson score method. Detection rate in the per-participant analysis is defined as number of participants with PET positive disease, independent of pathology or imaging/clinical follow-up. Detection rate in the per-region analysis is
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Laboratory Biomarker Analysis
- DRUG Fluciclovine F18
- DRUG Gallium Ga 68-labeled PSMA-11
Study Locations (1)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2019-04-12 |
| Est. Completion | 2019-04-25 |
| Phase | Phase 2 |
What the finished NCT03515577 record still lists
NCT03515577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 164-participant average among 29 other Recurrent Prostate Carcinoma trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Recurrent Prostate Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT03515577 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03515577 about?
NCT03515577 is a clinical study titled "Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery". This phase II trial compares how well gallium 68-labeled PSMA-11 positron emission tomography/computed tomography (PET/CT) works compared to fluciclovine F18 PET/CT in imaging participants with prostate cancer after surgery that has come back. PET is an established imaging technique that uses small ...
What is the current status of trial NCT03515577?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2019-04-12. Estimated completion is 2019-04-25.
What conditions does trial NCT03515577 study?
This clinical trial studies the following conditions: Recurrent Prostate Carcinoma.
What interventions are being tested in trial NCT03515577?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Fluciclovine F18 (DRUG), Gallium Ga 68-labeled PSMA-11 (DRUG).
Who is sponsoring clinical trial NCT03515577?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03515577 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03515577's enrollment target sits among peer trials
50 17th of 29 higher than 13 of 29 other Recurrent Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Prostate Carcinoma 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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