Clinical trial NCT03619980: 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
Official title: Retrospective Study to Evaluate Time to Event and Treatment of Prostate Cancer Patients Throughout the Disease States, From m1HSPC and m1CRPC Until Progression or Death.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Non interventional
Registry
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2018-08-08
Enrollment: 6908
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with prostate cancer registered in PPC.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* All patients registered in PPC.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Time from entry to exit either by progression or death from prostate cancer stage m0HSPC
timeFrame: 11 years
measure: Measure: Time from entry to exit either by progression or death from prostate cancer stage m1HSPC
timeFrame: 11 years
measure: Time from entry to exit either by progression or death from prostate cancer stage m0CRPC
timeFrame: 11 years
measure: Time from entry to exit either by progression or death from prostate cancer stage m1CRPC
timeFrame: 11 years
measure: 9785-MA-3631: Time from entry to exit either by progression or death from prostate cancer stage m1HSPC
timeFrame: 3.5 years
measure: 9785-MA-3631: Time from entry to exit either by progression or death from prostate cancer stage m1CRPC
timeFrame: 3.5 years
Secondary outcomes:
measure: Co-morbidities at disease stage m0HSPC
timeFrame: 11 years
measure: Co-morbidities at disease stage m1HSPC
timeFrame: 11 years
measure: Co-morbidities at disease stage m0CRPC
timeFrame: 11 years
measure: Co-morbidities at disease stage m1CRPC
timeFrame: 11 years
measure: Co-medications at disease stage m0HSPC as recorded in the registries
timeFrame: 11 years
measure: Co-medications at disease stage m1HSPC as recorded in the registries
timeFrame: 11 years
measure: Co-medications at disease stage m0CRPC as recorded in the registries
timeFrame: 11 years
measure: Co-medications at disease stage m1CRPC as recorded in the registries
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by number of prostate cancer treatment regimens
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by number of prostate cancer treatment regimens
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by number of prostate cancer treatment regimens
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by number of prostate cancer treatment regimens
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of prostate cancer treatment regimens
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of prostate cancer treatment regimens
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of prostate cancer treatment regimens
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of prostate cancer treatment regimens
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization in-patient
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization in-patient
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization in-patient
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization in-patient
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization frequency
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization frequency
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization frequency
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization frequency
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization duration
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization duration
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization duration
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization duration
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of hospital visits
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of hospital visits
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of hospital visits
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of hospital visits
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of hospital visits
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of hospital visits
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of hospital visits
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of hospital visits
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of imaging examinations
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of imaging examinations
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of imaging examinations
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of imaging examinations
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of imaging examinations
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of imaging examinations
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of imaging examinations
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of imaging examinations
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of laboratory tests
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of laboratory tests
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of laboratory tests
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of laboratory tests
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of laboratory tests
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of laboratory tests
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of laboratory tests
timeFrame: 11 years
measure: Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of laboratory tests
timeFrame: 11 years
measure: 9785-MA-3631: Co-morbidities at disease stage m0HSPC
timeFrame: 3.5 years
measure: 9785-MA-3631: Co-morbidities at disease stage m1HSPC
timeFrame: 3.5 years
measure: 9785-MA-3631: Co-morbidities at disease stage m0CRPC
timeFrame: 3.5 years
measure: 9785-MA-3631: Co-morbidities at disease stage m1CRPC
timeFrame: 3.5 years
measure: 9785-MA-3631: Co-medications at disease stage m0HSPC as recorded in the registries
timeFrame: 3.5 years
measure: 9785-MA-3631: Co-medications at disease stage m1HSPC as recorded in the registries
timeFrame: 3.5 years
measure: 9785-MA-3631: Co-medications at disease stage m0CRPC as recorded in the registries
timeFrame: 3.5 years
measure: 9785-MA-3631: Co-medications at disease stage m1CRPC as recorded in the registries
timeFrame: 3.5 years
measure: 9785-MA-3631: Prostate Cancer (PCa) treatments for the m1HSPC disease state
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Site SE46001
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Astellas Pharma Europe Ltd.
role: STUDY_DIRECTOR
References: