Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517719
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Real-world Experience With Lutetium 177Lu Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer an Observational Multicenter Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to describe routine clinical practice with lutetium 177Lu vipivotide tetraxetan on Health related quality of life HRQoL at baseline on treatment and post progression
Detailed Description:
This non-interventional observational prospective cohort study is using primary data collection to describe the routine clinical practice and HRQoL of patients with Metastatic castration-resistant prostate cancer mCRPC initiating lutetium 177Lu vipivotide tetraxetan using patient questionnaires
Data will be collected at the following time points pre-index if patient is eligible index date first application of lutetium 177Lu vipivotide tetraxetan during treatment at EoT and during follow-up
The duration of a treatment cycle is 6 weeks 1 week Patients will be treated for up to 6 cycles as per local label
EoT visit assessments will be performed after the last lutetium 177Lu vipivotide tetraxetan application
Follow-up period patient data will be collected if available up to 1 year after EoT
Data will be collected at the following time points pre-index if patient is eligible index date first application of lutetium 177Lu vipivotide tetraxetan during treatment at EoT and during follow-up
The duration of a treatment cycle is 6 weeks 1 week Patients will be treated for up to 6 cycles as per local label
EoT visit assessments will be performed after the last lutetium 177Lu vipivotide tetraxetan application
Follow-up period patient data will be collected if available up to 1 year after EoT
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: