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NCT03419442 · ClinicalTrials.gov registry record
Multi-academic Center Study of Xofigo Patients
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 150
- Enrollment target
NCT03419442: Completed study, sponsored by Bayer.
NCT03419442 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 150 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03419442 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
Study Summary
The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide. The specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the safety patterns of docetaxel use among mCRPC patients who received chemotherapy post radium-223.
Primary Outcome
Survival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause).
Interventions
- DRUG Taxotere
- DRUG Xofigo
- DRUG Jevtana
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2018-12-03 |
| Est. Completion | 2019-10-22 |
What the finished NCT03419442 record still lists
NCT03419442 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Taxotere is the first listed.
NCT03419442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03419442 about?
NCT03419442 is a clinical study titled "Multi-academic Center Study of Xofigo Patients". The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemoth...
What is the current status of trial NCT03419442?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2018-12-03. Estimated completion is 2019-10-22.
What interventions are being tested in trial NCT03419442?
The interventions under investigation include: Taxotere (DRUG), Xofigo (DRUG), Jevtana (DRUG).
Who is sponsoring clinical trial NCT03419442?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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