Patient Reported Outcomes in the CAstration-resistant Prostate cancer RegIstry

Phase 4

Completed

• Conditions: prostate cancer; prostate carcinoma; CRPC; 10038597

• Registration Number: NL-OMON44771
• Lead Sponsor: institute for Medical Technology Assessment, Erasmus Universiteit Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

unable to complete questionnaires

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: to determine the HRQOL at baseline and changes over time<br /><br>during CRPC treatment<br /><br>a. generic HRQOL by EQ VAS score and EQ-5D index value<br /><br>b. cancer specific HRQOL by EORTC QLQ-C30 score<br /><br>c. prostate cancer specific HRQOL by EORTC QLQ-PR25 score</p><br>

Secondary Outcome Measures

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