No registrations found.
ID
Source
Brief title
Health condition
Newly diagnosed metastatic hormone sensitive prostate cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) A comprehensive selection of PROM questionnaires are collected at pre-defined time points, enables comparison of health-related Quality-of-Life.
2) Comparison of clinical effectiveness between treatments.
3) Description of medical resource utilization and health economics.
4) Description of trends and variations in outcomes, diagnostic methods and treatment patterns for newly diagnosed mHSPC over time
Secondary outcome
Overall survival, progression-free survival, duration of treatments, changes to treatment, reasons for initiation/alteration/termination of anti-cancer treatment
Background summary
The objective of this study is to document the treatment patterns and outcomes, characteristics and management of patients with newly diagnosed mHSPC in routine clinical practice, independent of treatment used.
Study objective
This study is designed to generate data for informative purposes and as a resource for future analyses. Thus, the results will be presented descriptively, and no formal hypotheses will be pre-specified.
Study design
Patients will be followed 2 years from inclusion
Intervention
Not applicable
Inclusion criteria
Male, 18 years or older aged
Must have a confirmed newly diagnosis of metastatic hormone sensitive prostate cancer.
Must sign a participation agreement/ICF allowing data collection and source data verification in accordance with local requirements
Exclusion criteria
Currently enrolled in an investigational interventional study
Currently enrolled in an observational study sponsored or managed by a Janssen company
Patients with insufficient understanding of the Dutch language or cognitive impairment that impede proper answering of the questionnaires
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9719 |
| Other | Adviescommissie nWMO MEC-U/Twente : NWMO18.11.051 |