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

NCT03619980 | Completed

• 2 other identifiers: 9785-MA-31679785-MA-3631
• Study Type: observational
• Target: 6,908
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Non interventional; Registry

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (61)

• Co-morbidities at disease stage m0HSPC

  11 years

• Co-morbidities at disease stage m1HSPC

  11 years

• Co-morbidities at disease stage m0CRPC

  11 years

• Co-morbidities at disease stage m1CRPC

  11 years

• Co-medications at disease stage m0HSPC as recorded in the registries

  11 years

Study Arms (1)

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

Interventions

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.

Participants with prostate cancer

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with prostate cancer registered in PPC.

You may qualify if:

• All patients registered in PPC.

You may not qualify if:

• None.

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.: lead

Study Sites (1)

Site SE46001

Uppsala, 753 09, Sweden

Location

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Astellas Pharma Europe Ltd.

  Astellas Pharma Europe Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 11 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 8, 2018
• Study Start: September 13, 2018
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)