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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: Completed Early Phase 1 study of Bone Metastatic Castration-Resistant Prostate Cancer, sponsored by Duke University.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportion of patients who over-express ALP in the CTCs, defined as any over-expression, will be estimated using descriptive statistics at each time point. ALP expression will be concurrently examined in the bone metastatic biopsies of men as well, if evaluable tissue is available.
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 |
What the finished NCT02204943 record still lists
NCT02204943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02204943's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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