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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

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ClinicalTrials.gov Identifier: NCT03619980
Recruitment Status : Completed
First Posted : August 8, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )

Brief Summary:

Primary objective of this study is to describe the time in each prostate cancer stage from non-metastatic Hormone Sensitive Prostate Cancer (m0HSPC), metastatic Hormone Sensitive Prostate Cancer (m1HSPC), non-metastatic Castrate-Resistant Prostate Cancer (m0CRPC), metastatic Castrate-Resistant Prostate Cancer (m1CRPC) to progression or death.

The secondary objectives of this study are to describe co-medication at each disease stage, to describe co-morbidities at each disease stage and to describe the healthcare resource use and costs associated to each disease stage.


Condition or disease Intervention/treatment
Prostate Cancer 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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 1869 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 11 Years
Official Title: Retrospective Study to Evaluate Time to Event and Healthcare Resource Utilisation of Prostate Cancer Patients Throughout the Disease Stages, From m0HSPC, m1HSPC, m0CRPC, m1CRPC Until Progression or Death
Actual Study Start Date : September 13, 2018
Actual Primary Completion Date : November 28, 2018
Actual Study Completion Date : November 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).


Secondary Outcome Measures :
  1. Co-morbidities at disease stage m0HSPC [ Time Frame: 11 years ]
    The prevalence of different co-morbidities of interest will be summarized for each disease stage.

  2. Co-morbidities at disease stage m1HSPC [ Time Frame: 11 years ]
    The prevalence of different co-morbidities of interest will be summarized for each disease stage.

  3. Co-morbidities at disease stage m0CRPC [ Time Frame: 11 years ]
    The prevalence of different co-morbidities of interest will be summarized for each disease stage.

  4. Co-morbidities at disease stage m1CRPC [ Time Frame: 11 years ]
    The prevalence of different co-morbidities of interest will be summarized for each disease stage.

  5. Co-medications at disease stage m0HSPC as recorded in the registries [ Time Frame: 11 years ]
    The prevalence of different co-medications of interest will be summarized for each disease stage.

  6. Co-medications at disease stage m1HSPC as recorded in the registries [ Time Frame: 11 years ]
    The prevalence of different co-medications of interest will be summarized for each disease stage.

  7. Co-medications at disease stage m0CRPC as recorded in the registries [ Time Frame: 11 years ]
    The prevalence of different co-medications of interest will be summarized for each disease stage.

  8. Co-medications at disease stage m1CRPC as recorded in the registries [ Time Frame: 11 years ]
    The prevalence of different co-medications of interest will be summarized for each disease stage.

  9. 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 for each disease stage will be assessed by number of prostate cancer treatment regimens.

  10. 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 for each disease stage will be assessed by number of prostate cancer treatment regimens.

  11. 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 for each disease stage will be assessed by number of prostate cancer treatment regimens.

  12. 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 for each disease stage will be assessed by number of prostate cancer treatment regimens.

  13. 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 for each disease stage will be assessed by type of prostate cancer treatment regimens.

  14. 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 for each disease stage will be assessed by type of prostate cancer treatment regimens.

  15. 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 for each disease stage will be assessed by type of prostate cancer treatment regimens.

  16. 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 for each disease stage will be assessed by type of prostate cancer treatment regimens.

  17. 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 will be assessed by hospitalization in-patient. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).

  18. 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 will be assessed by hospitalization in-patient. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).

  19. 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 will be assessed by hospitalization in-patient. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).

  20. 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 will be assessed by hospitalization in-patient. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).

  21. 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 will be assessed by hospitalization frequency. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).

  22. 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 will be assessed by hospitalization frequency. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).

  23. 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 will be assessed by hospitalization frequency. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).

  24. 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 will be assessed by hospitalization frequency. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).

  25. 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 will be assessed by hospitalization duration. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).

  26. 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 will be assessed by hospitalization duration. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).

  27. 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 will be assessed by hospitalization duration. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).

  28. 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 will be assessed by hospitalization duration. Disease coding is according to International Classification of Diseases 10th Edition (ICD-10).

  29. 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 will be assessed by type of hospital visits.

  30. 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 will be assessed by type of hospital visits.

  31. 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 will be assessed by type of hospital visits.

  32. 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 will be assessed by type of hospital visits.

  33. 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 will be assessed by frequency of hospital visits.

  34. 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 will be assessed by frequency of hospital visits.

  35. 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 will be assessed by frequency of hospital visits.

  36. 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 will be assessed by frequency of hospital visits.

  37. 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 will be assessed by type of imaging examinations.

  38. 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 will be assessed by type of imaging examinations.

  39. 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 will be assessed by type of imaging examinations.

  40. Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of imaging examinations [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by type of imaging examinations.

  41. Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of imaging examinations [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by frequency of imaging examinations.

  42. Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of imaging examinations [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by frequency of imaging examinations.

  43. Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of imaging examinations [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by frequency of imaging examinations.

  44. Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of imaging examinations [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by frequency of imaging examinations.

  45. Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of laboratory tests [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by type of laboratory tests.

  46. Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of laboratory tests [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by type of laboratory tests.

  47. Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of laboratory tests [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by type of laboratory tests.

  48. Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of laboratory tests [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by type of laboratory tests.

  49. Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of laboratory tests [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by frequency of laboratory tests

  50. Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of laboratory tests [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by frequency of laboratory tests.

  51. Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of laboratory tests [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by frequency of laboratory tests.

  52. Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of laboratory tests [ Time Frame: 11 years ]
    Healthcare resource utilization and related costs will be assessed by frequency of laboratory tests.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with prostate cancer registered in PPC.
Criteria

Inclusion Criteria:

  • All patients registered in PPC.

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619980


Locations
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Sweden
Site SE46001
Uppsala, Sweden, 753 09
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
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Study Director: Astellas Pharma Europe Ltd. Astellas Pharma Europe Ltd.

Additional Information:

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Responsible Party: Astellas Pharma Europe Ltd.
ClinicalTrials.gov Identifier: NCT03619980     History of Changes
Other Study ID Numbers: 9785-MA-3167
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe Ltd. ):
Prostate Cancer
Non interventional
Registry

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases