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NCT03976843 · ClinicalTrials.gov registry record · Phase 2
Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
- 6
- Study locations
NCT03976843: Active Phase 2 study of Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT03976843 is a Phase 2 study of Prostate Cancer that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 175 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (71% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03976843, a Phase 2 study of Prostate Cancer, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 175 participants
- Enrollment target
- 6
- Study locations
Study Summary
Background: People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery. Objective: To test if a PET/CT scan before the prostate gland is removed can predict if prostate cancer will return. Also, to test if this approach is better or worse than the usual approach for prostate cancer. Eligibility: Men ages 18 and older with prostate cancer that appears to be contained within the prostate but is at risk of having spread Design: Participants will be screened with: * Medical history * Blood tests * CT and MRI scans: Participants will lie in a machine. The machine will take pictures of the body. * Bone scan Participants will have a radiotracer injected into a vein. They will have a PET/CT scan of their whole body 60-90 minutes later. During the scan, they will lie on their back and stay still. Within 60 days after the scan, participants will have surgery. This will remove the prostate gland and lymph nodes around it. Some tissue will be used for genetic testing. If the PET/CT scan suggests the cancer has spread, participants may need to have another biopsy within 60 days after the scan. After surgery, participants will have follow-up visits for 5 years. They will have 5 visits the first year and 2 the second. Then they will have visits once a year. If participants cancer returns, they will have repeat PET/CT scans.
Primary Outcome
progression-free survival which is improved over that of historical data from a general population
Conditions Studied
Interventions
- DRUG 18F-DCFPyL
Study Locations (6)
Maryland
- Johns Hopkins University - Baltimore
- National Institutes of Health Clinical Center - Bethesda
Louisiana
- Tulane University - New Orleans
Massachusetts
- Brigham and Women s Hospital - Boston
New York
- Memorial Sloan Kettering Cancer Center - New York
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2019-12-04 |
| Est. Completion | 2027-11-19 |
| Phase | Phase 2 |
What the registry record for NCT03976843 still lists
NCT03976843 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which 18F-DCFPyL is the first listed.
NCT03976843 lists 6 locations in 5 states (Maryland, Louisiana, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT03976843 about?
NCT03976843 is a clinical study titled "Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer". Background: People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery. Objective: To test if a PET/CT scan before the ...
What is the current status of trial NCT03976843?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2019-12-04. Estimated completion is 2027-11-19.
What conditions does trial NCT03976843 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT03976843?
The interventions under investigation include: 18F-DCFPyL (DRUG).
Who is sponsoring clinical trial NCT03976843?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03976843 being conducted?
This trial has 6 study locations across Louisiana, Maryland, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03976843's enrollment target sits among peer trials
175 245th of 735 higher than 490 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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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