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NCT02043678 · ClinicalTrials.gov registry record · Phase 3
Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms
A Phase 3 study of Prostatic Neoplasms, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 806
- Enrollment target
- 20
- Study locations
NCT02043678 is a Phase 3 study of Prostatic Neoplasms that has completed, run by Bayer. The registered enrollment target is 806 participants, above the 502-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (61% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT02043678, a Phase 3 study of Prostatic Neoplasms, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 806 participants
- Enrollment target
- 20
- Study locations
Study Summary
To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.
Conditions Studied
Interventions
- DRUG Abiraterone
- DRUG Prednisone/Prednisolone
- DRUG Radium-223 dichloride (Xofigo, BAY88-8223)
- DRUG Matching placebo (normal saline)
Study Locations (20)
Maryland
- - Baltimore
- - Rockville
- - Towson
Massachusetts
- - Boston
- - Burlington
Michigan
- - Detroit
- - Traverse City
Alaska
- - Anchorage
Arizona
- - Tucson
California
- - Oceanside
Colorado
- - Denver
District of Columbia
- - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 806 participants |
| Start Date | 2014-03-30 |
| Est. Completion | 2024-02-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02043678
The ClinicalTrials.gov registry entry for NCT02043678 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 806 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 502-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (61% higher). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Abiraterone is the first listed.
NCT02043678 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Maryland, Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT02043678 about?
NCT02043678 is a clinical study titled "Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms". To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.
What is the current status of trial NCT02043678?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 806 participants. The study started on 2014-03-30. Estimated completion is 2024-02-08.
What conditions does trial NCT02043678 study?
This clinical trial studies the following conditions: Prostatic Neoplasms.
What interventions are being tested in trial NCT02043678?
The interventions under investigation include: Abiraterone (DRUG), Prednisone/Prednisolone (DRUG), Radium-223 dichloride (Xofigo, BAY88-8223) (DRUG), Matching placebo (normal saline) (DRUG).
Who is sponsoring clinical trial NCT02043678?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02043678 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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