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

Prostate Cancer Clinical Trial

Official title:

Retrospective Study to Evaluate Time to Event and Healthcare Resource Utilization of Prostate Cancer Patients Throughout the Disease Stages, From m0HSPC, m1HSPC, m0CRPC, m1CRPC Until Progression or Death

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619980
• Other study ID #: 9785-MA-3167
• Status: Completed
• Start date: September 13, 2018
• Est. completion date: November 28, 2018

Study information

• Verified date: January 2020
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1869
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients registered in PPC.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Sweden	Site SE46001	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	11 years
Primary	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.	11 years
Primary	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.	11 years
Primary	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).	11 years
Secondary	Co-morbidities at disease stage m0HSPC	The prevalence of different co-morbidities of interest will be summarized for each disease stage.	11 years
Secondary	Co-morbidities at disease stage m1HSPC	The prevalence of different co-morbidities of interest will be summarized for each disease stage.	11 years
Secondary	Co-morbidities at disease stage m0CRPC	The prevalence of different co-morbidities of interest will be summarized for each disease stage.	11 years
Secondary	Co-morbidities at disease stage m1CRPC	The prevalence of different co-morbidities of interest will be summarized for each disease stage.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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).	11 years
Secondary	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).	11 years
Secondary	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).	11 years
Secondary	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).	11 years
Secondary	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).	11 years
Secondary	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).	11 years
Secondary	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).	11 years
Secondary	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).	11 years
Secondary	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).	11 years
Secondary	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).	11 years
Secondary	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).	11 years
Secondary	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).	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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	11 years
Secondary	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.	11 years
Secondary	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.	11 years
Secondary	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.	11 years

External Links

•   Link to results on Astellas Clinical Study Results website