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NCT02981368 · ClinicalTrials.gov registry record · Phase 2
Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
A Phase 2 study, sponsored by Progenics Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 385
- Enrollment target
NCT02981368: Completed Phase 2 study, sponsored by Progenics Pharmaceuticals.
NCT02981368 is a Phase 2 study that has completed, run by Progenics Pharmaceuticals. The registered enrollment target is 385 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (189% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02981368, a Phase 2 study, has completed, sponsored by Progenics Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 385 participants
- Enrollment target
Study Summary
This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Cohort B). Cohort B is complete and no longer recruiting subjects.
Primary Outcome
The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity t
Interventions
- DIAGNOSTIC_TEST PET/CT imaging
- DRUG 18F-DCFPyL Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 385 participants |
| Start Date | 2016-11 |
| Est. Completion | 2018-07 |
| Phase | Phase 2 |
What the finished NCT02981368 record still lists
NCT02981368 is an interventional study that assigns participants to a tested intervention. The registered 385 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 (189% higher).
The record links to 0 conditions, and to 2 interventions - of which PET/CT imaging is the first listed.
NCT02981368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02981368 about?
NCT02981368 is a clinical study titled "Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer". This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Coho...
What is the current status of trial NCT02981368?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 385 participants. The study started on 2016-11. Estimated completion is 2018-07.
What interventions are being tested in trial NCT02981368?
The interventions under investigation include: PET/CT imaging (DIAGNOSTIC_TEST), 18F-DCFPyL Injection (DRUG).
Who is sponsoring clinical trial NCT02981368?
This trial is sponsored by Progenics Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02981368's enrollment target sits among peer trials
385 109th of 2000 higher than 1,890 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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