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NCT02204943 · ClinicalTrials.gov registry record · Early Phase 1
Pharmacodynamic Study of Radium-223 in Men With Bone Metastatic Castration-Resistant Prostate Cancer
A Early Phase 1 study of Bone Metastatic Castration-Resistant Prostate Cancer, sponsored by Duke University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02204943 is a Early Phase 1 study of Bone Metastatic Castration-Resistant Prostate Cancer that has completed, run by Duke University. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02204943, a Early Phase 1 study of Bone Metastatic Castration-Resistant Prostate Cancer, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine biomarkers involved in osteomimicry in bone metastases and circulating tumor cells (CTCs) of men with mCRPC before and during therapy with the bone-targeting radiopharmaceutical radium-223. This study will also examine the bio-distribution of radium-223 in bone and bone metastases of men with mCRPC. The investigators hypothesize that bone metastases and CTCs in men with mCRPC will commonly express markers of EMT/plasticity and osteomimicry, not just in the normal surrounding osteoblastic stroma but in the epithelial tumor cells themselves and that radium-223 will target both of these compartments including the more mesenchymal/osteoblastic tumor cells and the surrounding osteoblasts in the active bone microenvironment, with a relative sparing of normal bone and bone marrow.
Conditions Studied
Interventions
- DEVICE Biomarker analysis
- DRUG Administration of radium-223
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-05-06 |
| Est. Completion | 2017-07-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02204943
The ClinicalTrials.gov registry entry for NCT02204943 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bone Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Biomarker analysis is the first listed.
NCT02204943 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT02204943 about?
NCT02204943 is a clinical study titled "Pharmacodynamic Study of Radium-223 in Men With Bone Metastatic Castration-Resistant Prostate Cancer". This study will examine biomarkers involved in osteomimicry in bone metastases and circulating tumor cells (CTCs) of men with mCRPC before and during therapy with the bone-targeting radiopharmaceutical radium-223. This study will also examine the bio-distribution of radium-223 in bone and bone metas...
What is the current status of trial NCT02204943?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2015-05-06. Estimated completion is 2017-07-31.
What conditions does trial NCT02204943 study?
This clinical trial studies the following conditions: Bone Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT02204943?
The interventions under investigation include: Biomarker analysis (DEVICE), Administration of radium-223 (DRUG).
Who is sponsoring clinical trial NCT02204943?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02204943 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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