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A Prospective Observational Study of Treatment Options in Men with metastatic hormone sensitive prostate cancer (mHSPC)

A Prospective Observational Study of Treatment Options in Men with metastatic hormone sensitive prostate cancer (mHSPC)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24642
Enrollment
450
Registered
2021-09-07
Start date
2020-05-28
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed metastatic hormone sensitive prostate cancer

Interventions

None listed

Sponsors

Janssen-Cilag B.V.
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Overall survival, progression-free survival, duration of treatments, changes to treatment, reasons for initiation/alteration/termination of anti-cancer treatment

Contacts

Public ContactKarien Lieverse

Janssen-Cilag B.V.

klievers@its.jnj.com+31611806578

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)