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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,908
- 试验地点
- 1
- 主要终点
- Time from entry to exit either by progression or death from prostate cancer stage m0HSPC
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients registered in PPC.
排除标准
- 未提供
结局指标
主要结局
Time from entry to exit either by progression or death from prostate cancer stage m0HSPC
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of hospital visits(11 years)
- Healthcare resource utilization and related costs in disease stage m1CRPC as measured by number of prostate cancer treatment regimens(11 years)
- 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)
- Co-medications at disease stage m1HSPC as recorded in the registries(11 years)
- Co-medications at disease stage m0CRPC as recorded in the registries(11 years)
- Co-medications at disease stage m1CRPC as recorded in the registries(11 years)
- Healthcare resource utilization and related costs in disease stage m0HSPC as measured 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(11 years)
- Healthcare resource utilization and related costs in disease stage m0CRPC as measured 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(11 years)
- Healthcare resource utilization and related costs in disease stage m1HSPC as measured 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(11 years)
- Healthcare resource utilization and related costs in disease stage m1CRPC as measured 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(11 years)
- Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization in-patient(11 years)
- Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization in-patient(11 years)
- Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization in-patient(11 years)
- Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization frequency(11 years)
- Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization frequency(11 years)
- Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization frequency(11 years)
- Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization frequency(11 years)
- Healthcare resource utilization and related costs in disease stage m0HSPC as measured by hospitalization duration(11 years)
- Healthcare resource utilization and related costs in disease stage m1HSPC as measured by hospitalization duration(11 years)
- Healthcare resource utilization and related costs in disease stage m0CRPC as measured by hospitalization duration(11 years)
- Healthcare resource utilization and related costs in disease stage m1CRPC as measured by hospitalization duration(11 years)
- Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of hospital visits(11 years)
- Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of hospital visits(11 years)
- Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of hospital visits(11 years)
- Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of hospital visits(11 years)
- Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of hospital visits(11 years)
- Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of hospital visits(11 years)
- Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of hospital visits(11 years)
- Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of imaging examinations(11 years)
- Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of imaging examinations(11 years)
- Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of imaging examinations(11 years)
- Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of imaging examinations(11 years)
- Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of imaging examinations(11 years)
- Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of imaging examinations(11 years)
- Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of imaging examinations(11 years)
- Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of imaging examinations(11 years)
- Healthcare resource utilization and related costs in disease stage m0HSPC as measured by type of laboratory tests(11 years)
- Healthcare resource utilization and related costs in disease stage m1HSPC as measured by type of laboratory tests(11 years)
- Healthcare resource utilization and related costs in disease stage m0CRPC as measured by type of laboratory tests(11 years)
- Healthcare resource utilization and related costs in disease stage m1CRPC as measured by type of laboratory tests(11 years)
- Healthcare resource utilization and related costs in disease stage m0HSPC as measured by frequency of laboratory tests(11 years)
- Healthcare resource utilization and related costs in disease stage m1HSPC as measured by frequency of laboratory tests(11 years)
- Healthcare resource utilization and related costs in disease stage m0CRPC as measured by frequency of laboratory tests(11 years)
- Healthcare resource utilization and related costs in disease stage m1CRPC as measured by frequency of laboratory tests(11 years)
- 9785-MA-3631: Co-morbidities at disease stage m0HSPC(3.5 years)
- 9785-MA-3631: Co-morbidities at disease stage m1HSPC(3.5 years)
- 9785-MA-3631: Co-morbidities at disease stage m0CRPC(3.5 years)
- 9785-MA-3631: Co-morbidities at disease stage m1CRPC(3.5 years)
- 9785-MA-3631: Co-medications at disease stage m0HSPC as recorded in the registries(3.5 years)
- 9785-MA-3631: Co-medications at disease stage m1HSPC as recorded in the registries(3.5 years)
- 9785-MA-3631: Co-medications at disease stage m0CRPC as recorded in the registries(3.5 years)
- 9785-MA-3631: Co-medications at disease stage m1CRPC as recorded in the registries(3.5 years)
- 9785-MA-3631: Prostate Cancer (PCa) treatments for the m1HSPC disease state(3.5 years)