An observational study in Prostate Cancer, sponsored by Astellas Pharma Europe Ltd.. Completed at 1 site in Sweden. Open to male participants. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Astellas Pharma Europe Ltd. · Observational
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.
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.
Participants with prostate cancer registered in PPC.
Exclusion Criteria:
This is a retrospective registry based study to collect real world data on participants with different disease stages of prostate cancer in Sweden.
Other: 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.
Time from entry to exit either by progression or death from prostate cancer stage m0HSPC
M0HSPC as defined by date for start of ADT (Androgen Deprivation Therapy) (bicalutamide or hormone therapy) and no date for metastatic disease.
Time frame: 11 years
Measure: Time from entry to exit either by progression or death from prostate cancer stage m1HSPC
M1HSPC as defined by date for start of ADT (bicalutamide or hormone therapy) and date for metastatic disease.
Time frame: 11 years
Time from entry to exit either by progression or death from prostate cancer stage m0CRPC
M0CRPC as defined by date for clinical assessment of CRPC (Castration Resistant Prostate Cancer) or PSA (Prostate-Specific Antigen) progression ((while on GnRH (Gonadotropin-Releasing Hormone) analogues)) and no date for metastases.
Time frame: 11 years
Time from entry to exit either by progression or death from prostate cancer stage m1CRPC
m1CRPC as defined by date for clinical assessment of CRPC or PSA progression (while on GnRH analogues) and confirmed by date for radiographic progression or initiation of treatment for mCRPC (metastatic castration-resistant prostate cancer).
Time frame: 11 years
9785-MA-3631: Time from entry to exit either by progression or death from prostate cancer stage m1HSPC
M1HSPC as defined by date for start of ADT (bicalutamide or hormone therapy) and date for metastatic disease.
Time frame: 3.5 years
9785-MA-3631: Time from entry to exit either by progression or death from prostate cancer stage m1CRPC
M1CRPC as defined by date for clinical assessment of CRPC or PSA progression (while on GnRH analogues) and confirmed by date for radiographic progression or initiation of treatment for mCRPC (metastatic castration-resistant prostate cancer).
Time frame: 3.5 years
Co-morbidities at disease stage m0HSPC
The prevalence of different co-morbidities of interest will be summarized for each disease stage.
Time frame: 11 years
Co-morbidities at disease stage m1HSPC
The prevalence of different co-morbidities of interest will be summarized for each disease stage.
Time frame: 11 years
Co-morbidities at disease stage m0CRPC
The prevalence of different co-morbidities of interest will be summarized for each disease stage.
Time frame: 11 years
Co-morbidities at disease stage m1CRPC
The prevalence of different co-morbidities of interest will be summarized for each disease stage.
Time frame: 11 years
Co-medications at disease stage m0HSPC as recorded in the registries
The prevalence of different co-medications of interest will be summarized for each disease stage.
Time frame: 11 years
Co-medications at disease stage m1HSPC as recorded in the registries
The prevalence of different co-medications of interest will be summarized for each disease stage.
Time frame: 11 years
Co-medications at disease stage m0CRPC as recorded in the registries
The prevalence of different co-medications of interest will be summarized for each disease stage.
Time frame: 11 years
Co-medications at disease stage m1CRPC as recorded in the registries
The prevalence of different co-medications of interest will be summarized for each disease stage.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by number of prostate cancer treatment regimens
Healthcare resource utilization and related costs for each disease stage will be assessed by number of prostate cancer treatment regimens.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by number of prostate cancer treatment regimens
Healthcare resource utilization and related costs for each disease stage will be assessed by number of prostate cancer treatment regimens.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by number of prostate cancer treatment regimens
Healthcare resource utilization and related costs for each disease stage will be assessed by number of prostate cancer treatment regimens.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by number of prostate cancer treatment regimens
Healthcare resource utilization and related costs for each disease stage will be assessed by number of prostate cancer treatment regimens.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of prostate cancer treatment regimens
Healthcare resource utilization and related costs for each disease stage will be assessed by type of prostate cancer treatment regimens.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of prostate cancer treatment regimens
Healthcare resource utilization and related costs for each disease stage will be assessed by type of prostate cancer treatment regimens.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of prostate cancer treatment regimens
Healthcare resource utilization and related costs for each disease stage will be assessed by type of prostate cancer treatment regimens.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of prostate cancer treatment regimens
Healthcare resource utilization and related costs for each disease stage will be assessed by type of prostate cancer treatment regimens.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization in-patient
Healthcare resource utilization and related costs will be assessed by hospitalization in-patient. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization in-patient
Healthcare resource utilization and related costs will be assessed by hospitalization in-patient. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization in-patient
Healthcare resource utilization and related costs will be assessed by hospitalization in-patient. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization in-patient
Healthcare resource utilization and related costs will be assessed by hospitalization in-patient. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization frequency
Healthcare resource utilization and related costs will be assessed by hospitalization frequency. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization frequency
Healthcare resource utilization and related costs will be assessed by hospitalization frequency. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization frequency
Healthcare resource utilization and related costs will be assessed by hospitalization frequency. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization frequency
Healthcare resource utilization and related costs will be assessed by hospitalization frequency. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization duration
Healthcare resource utilization and related costs will be assessed by hospitalization duration. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization duration
Healthcare resource utilization and related costs will be assessed by hospitalization duration. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization duration
Healthcare resource utilization and related costs will be assessed by hospitalization duration. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization duration
Healthcare resource utilization and related costs will be assessed by hospitalization duration. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of hospital visits
Healthcare resource utilization and related costs will be assessed by type of hospital visits.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of hospital visits
Healthcare resource utilization and related costs will be assessed by type of hospital visits.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of hospital visits
Healthcare resource utilization and related costs will be assessed by type of hospital visits.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of hospital visits
Healthcare resource utilization and related costs will be assessed by type of hospital visits.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of hospital visits
Healthcare resource utilization and related costs will be assessed by frequency of hospital visits.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of hospital visits
Healthcare resource utilization and related costs will be assessed by frequency of hospital visits.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of hospital visits
Healthcare resource utilization and related costs will be assessed by frequency of hospital visits.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of hospital visits
Healthcare resource utilization and related costs will be assessed by frequency of hospital visits.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of imaging examinations
Healthcare resource utilization and related costs will be assessed by type of imaging examinations.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of imaging examinations
Healthcare resource utilization and related costs will be assessed by type of imaging examinations.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of imaging examinations
Healthcare resource utilization and related costs will be assessed by type of imaging examinations.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of imaging examinations
Healthcare resource utilization and related costs will be assessed by type of imaging examinations.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of imaging examinations
Healthcare resource utilization and related costs will be assessed by frequency of imaging examinations.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of imaging examinations
Healthcare resource utilization and related costs will be assessed by frequency of imaging examinations.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of imaging examinations
Healthcare resource utilization and related costs will be assessed by frequency of imaging examinations.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of imaging examinations
Healthcare resource utilization and related costs will be assessed by frequency of imaging examinations.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of laboratory tests
Healthcare resource utilization and related costs will be assessed by type of laboratory tests.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of laboratory tests
Healthcare resource utilization and related costs will be assessed by type of laboratory tests.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of laboratory tests
Healthcare resource utilization and related costs will be assessed by type of laboratory tests.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of laboratory tests
Healthcare resource utilization and related costs will be assessed by type of laboratory tests.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of laboratory tests
Healthcare resource utilization and related costs will be assessed by frequency of laboratory tests
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of laboratory tests
Healthcare resource utilization and related costs will be assessed by frequency of laboratory tests.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of laboratory tests
Healthcare resource utilization and related costs will be assessed by frequency of laboratory tests.
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of laboratory tests
Healthcare resource utilization and related costs will be assessed by frequency of laboratory tests.
Time frame: 11 years
9785-MA-3631: Co-morbidities at disease stage m0HSPC
The prevalence of different co-morbidities of interest will be summarized for each disease stage.
Time frame: 3.5 years
9785-MA-3631: Co-morbidities at disease stage m1HSPC
The prevalence of different co-morbidities of interest will be summarized for each disease stage.
Time frame: 3.5 years
9785-MA-3631: Co-morbidities at disease stage m0CRPC
The prevalence of different co-morbidities of interest will be summarized for each disease stage.
Time frame: 3.5 years
9785-MA-3631: Co-morbidities at disease stage m1CRPC
The prevalence of different co-morbidities of interest will be summarized for each disease stage.
Time frame: 3.5 years
9785-MA-3631: Co-medications at disease stage m0HSPC as recorded in the registries
The prevalence of different co-medications of interest will be summarized for each disease stage.
Time frame: 3.5 years
9785-MA-3631: Co-medications at disease stage m1HSPC as recorded in the registries
The prevalence of different co-medications of interest will be summarized for each disease stage.
Time frame: 3.5 years
9785-MA-3631: Co-medications at disease stage m0CRPC as recorded in the registries
The prevalence of different co-medications of interest will be summarized for each disease stage.
Time frame: 3.5 years
9785-MA-3631: Co-medications at disease stage m1CRPC as recorded in the registries
The prevalence of different co-medications of interest will be summarized for each disease stage.
Time frame: 3.5 years
9785-MA-3631: Prostate Cancer (PCa) treatments for the m1HSPC disease state
PCa treatments collected (using real world data) in the m1HSPC population.
Time frame: 3.5 years
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Astellas Pharma Europe Ltd.