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NCT04158245 · ClinicalTrials.gov registry record · Phase 2
18F-fluciclovine PET in Metastatic Castration Resistant Prostate Cancer Treated With Life Prolonging Therapies
A Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Tulane University.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT04158245: Completed Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Tulane University.
NCT04158245 is a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer that has completed, run by Tulane University. The registered enrollment target is 9 participants, below the 198-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04158245, a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, has completed, sponsored by Tulane University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot phase 2 single-arm study, of men with metastatic castration-resistant prostate cancer (mCRPC). Patients will be treated with any of the approved life-prolonging therapies: abiraterone 1000 mg daily plus prednisone 5 mg (or dexamethasone 0.5 mg) daily, enzalutamide 160 mg daily, or docetaxel 50 mg/m2 every two weeks or 75 mg/m2 every three weeks.
Primary Outcome
To describe the 18F-fluciclovine PET findings for patients with mCRPC prior to starting treatment with Life Prolonging Therapies, and at 12 weeks after Life Prolonging Therapies treatment initiation. We have 4 categories that can be seen in the scan to measure the metabolic response using PERSIST 1.1, 1)stable disease, 2)progressive disease, 3)partial response and 4)complete response.
Conditions Studied
Interventions
- DRUG 18F-fluciclovine PET Scan
Study Locations (1)
Louisiana
- Tulane Cancer Center Clinic - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-01-30 |
| Est. Completion | 2023-04-03 |
| Phase | Phase 2 |
What the finished NCT04158245 record still lists
NCT04158245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 198-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which 18F-fluciclovine PET Scan is the first listed.
NCT04158245 reports a single indexed study location in Louisiana.
Frequently Asked Questions
What is clinical trial NCT04158245 about?
NCT04158245 is a clinical study titled "18F-fluciclovine PET in Metastatic Castration Resistant Prostate Cancer Treated With Life Prolonging Therapies". This is a pilot phase 2 single-arm study, of men with metastatic castration-resistant prostate cancer (mCRPC). Patients will be treated with any of the approved life-prolonging therapies: abiraterone 1000 mg daily plus prednisone 5 mg (or dexamethasone 0.5 mg) daily, enzalutamide 160 mg daily, or do...
What is the current status of trial NCT04158245?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2020-01-30. Estimated completion is 2023-04-03.
What conditions does trial NCT04158245 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT04158245?
The interventions under investigation include: 18F-fluciclovine PET Scan (DRUG).
Who is sponsoring clinical trial NCT04158245?
This trial is sponsored by Tulane University, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04158245 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04158245's enrollment target sits among peer trials
9 70th of 69 the lowest of 69 other Metastatic Castration-Resistant Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Castration-Resistant 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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