A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer
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ClinicalTrials.gov Identifier: NCT03574571 |
Recruitment Status :
Recruiting
First Posted : July 2, 2018
Last Update Posted : April 25, 2024
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Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
Bayer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 20, 2018 | ||||||||
First Posted Date ICMJE | July 2, 2018 | ||||||||
Last Update Posted Date | April 25, 2024 | ||||||||
Actual Study Start Date ICMJE | June 19, 2018 | ||||||||
Estimated Primary Completion Date | June 1, 2026 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Overall survival [ Time Frame: 2 years ] Overall survival is defined as the time from randomization to death from any cause.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer | ||||||||
Official Title ICMJE | Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC) | ||||||||
Brief Summary | The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: This is an open-labeled, randomized, phase III study of docetaxel versus docetaxel in combination with radium-223 in subjects with mCRPC. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
738 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 1, 2026 | ||||||||
Estimated Primary Completion Date | June 1, 2026 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Brazil, Netherlands, Spain, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03574571 | ||||||||
Other Study ID Numbers ICMJE | 18-150 2018-002944-10 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Memorial Sloan Kettering Cancer Center | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Bayer | ||||||||
Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | ||||||||
Verification Date | April 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |