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.
ID
Bron
Verkorte titel
Aandoening
Newly diagnosed metastatic hormone sensitive prostate cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Patients will be followed 2 years from inclusion
Onderzoeksproduct en/of interventie
Not applicable
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9719 |
| Ander register | Adviescommissie nWMO MEC-U/Twente : NWMO18.11.051 |