Prostate CancerNCT03619980
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
An observational study of Prostate Cancer, run by Astellas Pharma Europe Ltd. at 1 site in Sweden.
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)… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 6,908 participants
- Where
- 1 siteSweden
- Study dates
- 13 Sep 2018to 10 Dec 2024
- How long will I take part?
- 11 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with prostate cancer registered in PPC.
Who may be able to join
- All patients registered in PPC.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- No intervention
- Keywords
- Prostate Cancer, Non interventional, Registry
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Retrospective study to evaluate time to event and healthcare resource utilisation of prostate cancer patients throughout the different disease stages, until progression or death.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 3.5 years
Secondary outcomes (61)
Co-morbidities at disease stage m0HSPC
The prevalence of different co-morbidities of interest will be summarized for each disease stage.
Measured: 11 years
Co-morbidities at disease stage m1HSPC
The prevalence of different co-morbidities of interest will be summarized for each disease stage.
Measured: 11 years
Co-morbidities at disease stage m0CRPC
The prevalence of different co-morbidities of interest will be summarized for each disease stage.
Measured: 11 years
Co-morbidities at disease stage m1CRPC
The prevalence of different co-morbidities of interest will be summarized for each disease stage.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start13 Sep 2018
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 6,908 participants (actual)
- Target duration
- 11 Years
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Astellas Pharma Europe Ltd., Study director, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619980
- Sponsor's protocol ID
- 9785-MA-3167
- Other IDs
- 9785-MA-3631
- Status last verified
- Jan 2025
- First submitted
- 2 Aug 2018
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03619980
- Acronym / sponsor ID
- 9785-MA-3167
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Non interventional, Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,908 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 11 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with prostate cancer | – | Other: No interventionThis is a retrospective registry based study to collect real world data on participants with different disease stages of prostate cancer in Sweden. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with prostate cancer registered in PPC.
Key inclusion criteria (1 listed)
- All patients registered in PPC.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionRetrospective study to evaluate time to event and healthcare resource utilisation of prostate cancer patients throughout the different disease stages, until progression or death. | Other | Participants with prostate cancer |
Primary outcome
Time from entry to exit either by progression or death from prostate cancer stage m0HSPC
Time frame: 11 years
M0HSPC as defined by date for start of ADT (Androgen Deprivation Therapy) (bicalutamide or hormone therapy) and no date for metastatic disease.
Measure: Time from entry to exit either by progression or death from prostate cancer stage m1HSPC
Time frame: 11 years
M1HSPC as defined by date for start of ADT (bicalutamide or hormone therapy) and date for metastatic disease.
Time from entry to exit either by progression or death from prostate cancer stage m0CRPC
Time frame: 11 years
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 from entry to exit either by progression or death from prostate cancer stage m1CRPC
Time frame: 11 years
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).
9785-MA-3631: Time from entry to exit either by progression or death from prostate cancer stage m1HSPC
Time frame: 3.5 years
M1HSPC as defined by date for start of ADT (bicalutamide or hormone therapy) and date for metastatic disease.
9785-MA-3631: Time from entry to exit either by progression or death from prostate cancer stage m1CRPC
Time frame: 3.5 years
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).
61 secondary outcomes
Co-morbidities at disease stage m0HSPC
Time frame: 11 years
Co-morbidities at disease stage m1HSPC
Time frame: 11 years
Co-morbidities at disease stage m0CRPC
Time frame: 11 years
Co-morbidities at disease stage m1CRPC
Time frame: 11 years
Co-medications at disease stage m0HSPC as recorded in the registries
Time frame: 11 years
Co-medications at disease stage m1HSPC as recorded in the registries
Time frame: 11 years
Co-medications at disease stage m0CRPC as recorded in the registries
Time frame: 11 years
Co-medications at disease stage m1CRPC as recorded in the registries
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured 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
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured 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
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured 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
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured 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
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization in-patient
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization in-patient
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization in-patient
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization in-patient
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization frequency
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization frequency
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization frequency
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization frequency
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization duration
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization duration
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization duration
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization duration
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured 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
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured 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
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured 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
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured 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
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0HSPC as measured 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
Time frame: 11 years
Healthcare resource utilization and related costs in disease stage m0CRPC as measured 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
Time frame: 11 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astellas Pharma Europe Ltd. study director
Astellas Pharma Europe Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Astellas Pharma Europe Ltd. at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from entry to exit either by progression or death from prostate cancer stage m0HSPC (time frame: 11 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.