Patient Reported Outcomes in the CAstration-resistant Prostate cancer RegIstry

Patient Reported Outcomes in the CAstration-resistant Prostate cancer RegIstry - PRO-CAPRI

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44771

Enrollment

200

Registered

2013-07-09

Start date

2013-06-27

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

prostate cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. CRPC, newly diagnosed, as defined by either the treating doctor/physician, or by the definition: prostate cancer that is progressing despite medical or surgical castration. OR 2. CRPC, progressive on docetaxel and starting the first post-docetaxel line of anti-cancer treatment

Exclusion criteria

Exclusion criteria: unable to complete questionnaires

Design outcomes

Primary

Measure	Time frame
Primary endpoint: to determine the HRQOL at baseline and changes over time during CRPC treatment a. generic HRQOL by EQ VAS score and EQ-5D index value b. cancer specific HRQOL by EORTC QLQ-C30 score c. prostate cancer specific HRQOL by EORTC QLQ-PR25 score	—

Secondary

Measure	Time frame
Secondary endpoint: to determine a. indirect non-medical costs during CRPC treatment (productivity losses due to absenteeism) b. direct medical costs outside the hospital during CRPC treatment (medical resource use outside the hospital and informal care) c. self-reported pain by BPI-SF pain severity and interference	—

Countries

Netherlands

Outcome results