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NCT03181867 · ClinicalTrials.gov registry record · Phase 2
18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 360
- Enrollment target
NCT03181867: Active Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03181867 is a Phase 2 study that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 360 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (171% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03181867, a Phase 2 study, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 360 participants
- Enrollment target
Study Summary
Background: Prostate cancer is the second leading cause of cancer deaths in American men. When prostate cancer is confined to the prostate there is a high chance of cure. However, it is outside the prostate or comes back after treatment, additional therapy may be needed. Current methods of imaging prostate cancer are limited. Researchers want to see if a radiotracer called 18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading outside the prostate or who have signs of recurrent cancer after treatment. Objectives: To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or after therapy. Eligibility: Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed after radiation or surgery Design: Participants will be divided into 2 groups. * Group 1 will be men with cancer that has been newly diagnosed as high risk by their doctor who are scheduled to have prostate removal surgery or undergo biopsy before radiation therapy. * Group 2 will be men who have presumed prostate cancer relapse after prostate removal surgery or radiation therapy. Both groups will have scans taken. Participants will lie still on a table in a machine that takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line. Participants will be contacted for follow-up after scans. Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove some prostate tissue. This procedure will be standard of care and is not a part of this study. They will also have an extra MRI scan of their prostate. For this, a tube, called an endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside of their pelvis. A contrast agent will be given by IV. Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of abnormalities found on the 18F-DCFyL scan. Participants will have data about their prosta
Primary Outcome
Correlation between 18F-DCFPyL scanning and accurately staging of high-risk primary prostate cancer and detection of sites of recurrent prostate cancer.
Interventions
- DRUG 18F-FDG
- DRUG 18F-DCFPyL
- DRUG PSMA-11
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2017-08-03 |
| Est. Completion | 2031-02-01 |
| Phase | Phase 2 |
What the registry record for NCT03181867 still lists
NCT03181867 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (171% higher).
The record links to 0 conditions, and to 3 interventions - of which 18F-FDG is the first listed.
NCT03181867 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03181867 about?
NCT03181867 is a clinical study titled "18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer". Background: Prostate cancer is the second leading cause of cancer deaths in American men. When prostate cancer is confined to the prostate there is a high chance of cure. However, it is outside the prostate or comes back after treatment, additional therapy may be needed. Current methods of imaging ...
What is the current status of trial NCT03181867?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 360 participants. The study started on 2017-08-03. Estimated completion is 2031-02-01.
What interventions are being tested in trial NCT03181867?
The interventions under investigation include: 18F-FDG (DRUG), 18F-DCFPyL (DRUG), PSMA-11 (DRUG).
Who is sponsoring clinical trial NCT03181867?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03181867's enrollment target sits among peer trials
360 123rd of 2000 higher than 1,874 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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