A Non-Interventional Study to Evaluate Time to Event and Healthcare Resource Utilisation for Prostate Cancer Participants Throughout the Disease Trajectories Until Progression or Death
NCT ID: NCT03619980
Last Updated: 2025-01-13
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
6908 participants
OBSERVATIONAL
2018-09-13
2024-12-10
Brief Summary
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The secondary objectives of this study are to describe co-medication at each disease stage, to describe co-morbidities at each disease stage and to describe the healthcare resource use and costs associated to each disease stage.
This study has been opened and amended (amendment 2; also known as 9785-MA-3631 study) to describe the time in each prostate cancer state from m1HSPC to progression or death. The secondary objective for amendment 2 is to describe co-medication at each disease state, describe co-morbidities at each disease state, and describe PCa treatments in the m1HSPC state. The aim of the second amendment is to provide up to date real world data on the change of the treatment landscape in the m1HSPC population from 1 January 2021 to 30 June 2024.
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Detailed Description
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Data will be extracted from PPC for the different Prostate Cancer (PCa) disease stages, from m0HSPC, m1HSPC, m0CRPC, m1CRPC until progression or death. The prostate cancer disease progression from m0HSPC, m1HSPC, m0CRPC, m1CRPC until progression or death has not been recorded in a systematic way. Given the complexity of this disease, the aim of this study is to have a comprehensive understanding about the disease progression in prostate cancer, from m0HSPC, m1HSPC, m0CRPC, m1CRPC until progression or death.
In addition, the following will be collected: co-morbidities, co-medication, health care resource utilization and costs, as well as other health economic variables such as sick leave and early retirement at the different disease stages.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Participants with prostate cancer
This is a retrospective registry based study to collect real world data on participants with different disease stages of prostate cancer in Sweden.
No intervention
Retrospective study to evaluate time to event and healthcare resource utilisation of prostate cancer patients throughout the different disease stages, until progression or death.
Interventions
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No intervention
Retrospective study to evaluate time to event and healthcare resource utilisation of prostate cancer patients throughout the different disease stages, until progression or death.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
MALE
No
Sponsors
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Astellas Pharma Europe Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Astellas Pharma Europe Ltd.
Role: STUDY_DIRECTOR
Astellas Pharma Europe Ltd.
Locations
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Site SE46001
Uppsala, , Sweden
Countries
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Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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9785-MA-3631
Identifier Type: OTHER
Identifier Source: secondary_id
9785-MA-3167
Identifier Type: -
Identifier Source: org_study_id
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