- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04587427
A Study to Learn More About How Radium-223 is Being Used With Other Treatments in European Patients Who Have Not Received Radium-223 Before (DIRECT)
Drug utilisatIon Study of Radium 223 Under Routine Clinical Practice in Europe
In this study data from people with metastatic castration-resistant prostate cancer (mCRPC) with bone metastasis are studied. mCRPC is a prostate cancer which has spread to other parts of the body even when the amount of testosterone in the body was reduced. Bone metastasis is when the cancer has spread to the bones.
The study drug, radium-223, is currently available as a treatment for mCRPC with bone metastasis. But, its combination with certain other cancer treatments may lead to medical problems. Therefore the instructions about how doctors should use radium-223 with other cancer treatments were changed.
In this study, the researchers want to learn more about how doctors are now using radium-223 to treat patients with mCRPC and bone metastasis.
The participants in this study will include men in Denmark, Germany, or the Netherlands. They will not have received radium-223 before. They will have at least 6 months of medical records before starting treatment with radium-223. The researchers will collect the participants' medical records up to December 2020.
The researchers will review information from the participants' medical records and medical claims from hospitals where the participants received radium-223. They will look at the medical records of participants who first started receiving radium-223 before there were new instructions about using it with other cancer treatments. They will also look at the medical records of participants who first started receiving radium-223 after there were new instructions.
They will then count how many participants received other specific cancer treatments with radium-223. They will compare the results of the participants' who received radium-223 before the new instructions and those who received it after the new instructions.
There are no required visits or tests in this study.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Multiple Locations, Denmark
- Many Locations
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Multiple Locations, Germany
- Many Locations
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Multiple Locations, Netherlands
- Many Locations
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who receive a first dispensing/administration of radium-223 during the before or after study period
- Patients who have at least 6 months of continuous enrolment in the study databases before the first dispensing/administration of radium-223 (to allow for evaluation of recent medical history and medication use)
Exclusion Criteria:
- Patients who used radium-223 ever before the start of the before study period
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Radium-223
Subjects who received the treatment of radium-223 during the before or after label change study periods.
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Prescribed by physicians.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The proportion of patients who use radium-223 in combination with abiraterone acetate
Time Frame: Data will be collected from Nov 2013 to Dec 2020
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Data will be collected from Nov 2013 to Dec 2020
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The proportion of patients who use radium-223 in combination with other systemic therapies for mCRPC, except luteinising hormone-releasing hormone (LHRH) analogues
Time Frame: Data will be collected from Nov 2013 to Dec 2020
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Data will be collected from Nov 2013 to Dec 2020
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The proportion of patients who use radium-223 without having received at least two prior lines of systemic therapy for mCRPC, except LHRH analogues
Time Frame: Data will be collected from Nov 2013 to Dec 2020
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Data will be collected from Nov 2013 to Dec 2020
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference between before and after the label change periods in the proportion of patients who use radium-223 in combination with abiraterone acetate
Time Frame: Data will be collected from Nov 2013 to Dec 2020
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Data will be collected from Nov 2013 to Dec 2020
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The difference between before and after the label change periods in the proportion of patients who use radium-223 in combination with other systemic therapies for mCRPC, except luteinising hormone-releasing hormone (LHRH) analogues
Time Frame: Data will be collected from Nov 2013 to Dec 2020
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Data will be collected from Nov 2013 to Dec 2020
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The difference between before and after the label change periods in the proportion of patients who use radium-223 without having received at least two prior lines of systemic therapy for mCRPC, except LHRH analogues
Time Frame: Data will be collected from Nov 2013 to Dec 2020
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Data will be collected from Nov 2013 to Dec 2020
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Descriptive summary of patient characteristics
Time Frame: Data will be collected from Nov 2013 to Dec 2020
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Including:
U/L):
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Data will be collected from Nov 2013 to Dec 2020
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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