Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2018-12-03
2019-10-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Ra-223 therapy before chemotherapy
Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy
Xofigo
Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection
Taxotere
Docetaxel injection 75mg/m2 every 3 weeks
Jevtana
Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks
Ra-223 after chemotherapy
Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy
Xofigo
Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection
Taxotere
Docetaxel injection 75mg/m2 every 3 weeks
Jevtana
Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks
Interventions
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Xofigo
Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection
Taxotere
Docetaxel injection 75mg/m2 every 3 weeks
Jevtana
Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks
Eligibility Criteria
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Inclusion Criteria
* Received at least one prescription or dose of chemotherapy for treatment of mCRPC
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Bayer US
Whippany, New Jersey, United States
Countries
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Related Links
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Click here to find results for studies related to Bayer products
Other Identifiers
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19863
Identifier Type: -
Identifier Source: org_study_id
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