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NCT03824275 · ClinicalTrials.gov registry record · Phase 2
18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer
A Phase 2 study of Prostatic Neoplasms, sponsored by Columbia University.
- Active
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
- 1
- Study location
NCT03824275: Active Phase 2 study of Prostatic Neoplasms, sponsored by Columbia University.
NCT03824275 is a Phase 2 study of Prostatic Neoplasms that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 129 participants, below the 512-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03824275, a Phase 2 study of Prostatic Neoplasms, is active but no longer recruiting, sponsored by Columbia University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
- 1
- Study location
Study Summary
PyL, also known as \[18F\]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. Its ability to image metastatic prostate cancer sites was comparable to 68Ga-PSMA with high tumor-to-background ratios.Additionally, \[18F\] PyL demonstrated higher mean tumor-to-background ratios when using kidney, spleen, or parotid as reference organs. However, the role of \[18F\] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.
Primary Outcome
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis
Conditions Studied
Interventions
- DRUG 18F- DCFPyL PET/CT
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2019-02-12 |
| Est. Completion | 2023-12 |
| Phase | Phase 2 |
What the registry record for NCT03824275 still lists
NCT03824275 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 512-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which 18F- DCFPyL PET/CT is the first listed.
NCT03824275 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03824275 about?
NCT03824275 is a clinical study titled "18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer". PyL, also known as \[18F\]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. Its ability to image metastatic prostate c...
What is the current status of trial NCT03824275?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2019-02-12. Estimated completion is 2023-12.
What conditions does trial NCT03824275 study?
This clinical trial studies the following conditions: Prostatic Neoplasms.
What interventions are being tested in trial NCT03824275?
The interventions under investigation include: 18F- DCFPyL PET/CT (DRUG).
Who is sponsoring clinical trial NCT03824275?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03824275 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 NCT03824275's enrollment target sits among peer trials
129 36th of 65 higher than 30 of 65 other Prostatic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms 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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