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Completed

NCT Number: NCT03619980

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Site SE46001

Uppsala, 753 09, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients registered in PPC.

Exclusion criteria

  • None.

Treatment and study plan

No intervention

Other

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 outcomes

  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).

  5. 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.

  6. 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).

Secondary outcomes

  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.

  53. 9785-MA-3631: Co-morbidities at disease stage m0HSPC

    Time frame: 3.5 years

    The prevalence of different co-morbidities of interest will be summarized for each disease stage.

  54. 9785-MA-3631: Co-morbidities at disease stage m1HSPC

    Time frame: 3.5 years

    The prevalence of different co-morbidities of interest will be summarized for each disease stage.

  55. 9785-MA-3631: Co-morbidities at disease stage m0CRPC

    Time frame: 3.5 years

    The prevalence of different co-morbidities of interest will be summarized for each disease stage.

  56. 9785-MA-3631: Co-morbidities at disease stage m1CRPC

    Time frame: 3.5 years

    The prevalence of different co-morbidities of interest will be summarized for each disease stage.

  57. 9785-MA-3631: Co-medications at disease stage m0HSPC as recorded in the registries

    Time frame: 3.5 years

    The prevalence of different co-medications of interest will be summarized for each disease stage.

  58. 9785-MA-3631: Co-medications at disease stage m1HSPC as recorded in the registries

    Time frame: 3.5 years

    The prevalence of different co-medications of interest will be summarized for each disease stage.

  59. 9785-MA-3631: Co-medications at disease stage m0CRPC as recorded in the registries

    Time frame: 3.5 years

    The prevalence of different co-medications of interest will be summarized for each disease stage.

  60. 9785-MA-3631: Co-medications at disease stage m1CRPC as recorded in the registries

    Time frame: 3.5 years

    The prevalence of different co-medications of interest will be summarized for each disease stage.

  61. 9785-MA-3631: Prostate Cancer (PCa) treatments for the m1HSPC disease state

    Time frame: 3.5 years

    PCa treatments collected (using real world data) in the m1HSPC population.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2018
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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