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NCT03585114 · ClinicalTrials.gov registry record · Phase 2
Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers
A Phase 2 study of Metastatic Prostate Cancer, sponsored by Columbia University.
- Active
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT03585114: Active Phase 2 study of Metastatic Prostate Cancer, sponsored by Columbia University.
NCT03585114 is a Phase 2 study of Metastatic Prostate Cancer that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 11 participants, below the 186-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03585114, a Phase 2 study of Metastatic Prostate Cancer, is active but no longer recruiting, sponsored by Columbia University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: * To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria. Secondary Objectives: * To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans correlate with overall survival (OS) * To determine whether baseline SUVmax correlate with rPFS * To compare number of lesions detected with standard imaging at baseline and at the time of progression
Primary Outcome
To determine if changes in PyL PET/CT scans before and after 6 weeks on treatment is associated with stability of disease as measured by standard imaging.
Conditions Studied
Interventions
- DRUG [F-18] DCFPyL
- PROCEDURE PET/CT imaging
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-12-11 |
| Est. Completion | 2022-12 |
| Phase | Phase 2 |
What the registry record for NCT03585114 still lists
NCT03585114 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 186-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Metastatic Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which [F-18] DCFPyL is the first listed.
NCT03585114 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03585114 about?
NCT03585114 is a clinical study titled "Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers". Primary Objective: * To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3)...
What is the current status of trial NCT03585114?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2018-12-11. Estimated completion is 2022-12.
What conditions does trial NCT03585114 study?
This clinical trial studies the following conditions: Metastatic Prostate Cancer.
What interventions are being tested in trial NCT03585114?
The interventions under investigation include: [F-18] DCFPyL (DRUG), PET/CT imaging (PROCEDURE).
Who is sponsoring clinical trial NCT03585114?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03585114 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03585114's enrollment target sits among peer trials
11 40th of 41 higher than 2 of 41 other Metastatic Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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