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

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.

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 6908

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 753 09
    • Site SE46001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with prostate cancer registered in PPC.

Description

Inclusion Criteria:

• All patients registered in PPC.

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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.	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).	3.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Co-morbidities at disease stage m0HSPC	The prevalence of different co-morbidities of interest will be summarized for each disease stage.	11 years
Co-morbidities at disease stage m1HSPC	The prevalence of different co-morbidities of interest will be summarized for each disease stage.	11 years
Co-morbidities at disease stage m0CRPC	The prevalence of different co-morbidities of interest will be summarized for each disease stage.	11 years
Co-morbidities at disease stage m1CRPC	The prevalence of different co-morbidities of interest will be summarized for each disease stage.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	3.5 years

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe Ltd.
• Investigators: Study Director: Astellas Pharma Europe Ltd., Astellas Pharma Europe Ltd.

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Prostate Cancer; Registry; Non interventional
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 9785-MA-3167; 9785-MA-3631 (Other Identifier: Amendment 2 to main study 9785-MA-3167)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No