Ignite Creation Date:
2024-05-06 @ 4:28 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04995614
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2021-07-16
Brief Title:
Health-related Quality of Life Psychological Distress and Fatigue in Metastatic CRPC Patients Treated With Radium-223
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
The Evaluation of the Health-related Quality of Life Psychological Distress and Fatigue in Metastatic Castration-resistant Prostate Cancer Patients Treated With Radium-223 Therapy a Multicenter Prospective Observational Cohort Study
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the current prospective multicenter study is to evaluate cancer-specific and bone metastases related HR-QoL psychological distress and fatigue in mCRPC patients before during and after treatment with radium-223 in daily practice Furthermore the investigators aim to determine patient groups with identical health-related quality of life patterns over time in order to identify variables related to health-related quality of life deterioration during the course of treatment as patients with health-related quality of life deterioration may need specific attention to preserve health-related quality of life
Detailed Description:
Radium-223 is a registered treatment option for patients with symptomatic bone metastatic castration-resistant prostate cancer Previously the phase 3 ALSYMPCA trial demonstrated that radium-223 improved overall survival and prolonged the time to the first symptomatic skeletal event and the time to first opioid use irrespective of prior docetaxel chemotherapy Subsequent analysis of the ALSYMPCA study showed that a significantly higher percentage of patients receiving radium-223 experienced meaningful HR-QoL improvement as measured by the EQ-5D questionnaire and the FACT-P questionnaire when compared to patients treated with placebo However studies evaluating health-related quality of life psychological distress and fatigue in metastatic castration-resistant prostate cancer patients treated with radium-223 in daily practice are lacking
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MOURO27 | OTHER | Radboudumc | None |