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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

6908 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-13

Study Completion Date

2024-12-10

Brief Summary

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Primary objective of this study is to describe the time in each prostate cancer stage from non-metastatic Hormone Sensitive Prostate Cancer (m0HSPC), metastatic Hormone Sensitive Prostate Cancer (m1HSPC), non-metastatic Castrate-Resistant Prostate Cancer (m0CRPC), metastatic Castrate-Resistant Prostate Cancer (m1CRPC) to progression or death.

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.

Detailed Description

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This is a retrospective analysis of Prostate Cancer patients from m0HSPC, m1HSPC, m0CRPC, m1CRPC followed in the Prostate Cancer Database Sweden (PCBaSe) database. The patient population consists of men recorded in Patient-overview Prostate Cancer (PPC) between 1 January 2014 until death or 31 December 2016. Patient history to 2006 was collected by retrospective charted review.

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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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients registered in PPC.

Exclusion Criteria

* None.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Sweden

Related Links

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https://astellasclinicalstudyresults.com/study.aspx?ID=347

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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