A Prospective Observational Study of Treatment Options in Men with metastatic hormone sensitive prostate cancer (mHSPC)
Recruiting
- Conditions
- ewly diagnosed metastatic hormone sensitive prostate cancer
- Registration Number
- NL-OMON24642
- Lead Sponsor
- Janssen-Cilag B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) A comprehensive selection of PROM questionnaires are collected at pre-defined time points, enables comparison of health-related Quality-of-Life. <br>2) Comparison of clinical effectiveness between treatments. <br>3) Description of medical resource utilization and health economics. <br>4) Description of trends and variations in outcomes, diagnostic methods and treatment patterns for newly diagnosed mHSPC over time
- Secondary Outcome Measures
Name Time Method Overall survival, progression-free survival, duration of treatments, changes to treatment, reasons for initiation/alteration/termination of anti-cancer treatment