Status:
RECRUITING
Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Metastatic Castration Resistant Prostate Cancer
Eligibility:
MALE
18-99 years
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 pr...
Eligibility Criteria
Inclusion
- All patients must meet the following inclusion criteria during the identification period:
- Adult male patients diagnosed with mCRPC and initiating lutetium (177Lu) vipivotide tetraxetan by treating physician as per local label. After treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of Cycle 1.
- ≥ 18 years old at the time of enrollment
- Written informed consent must be obtained prior to any data collection
- Willing to participate in Quality of Life post treatment date collection for 1 year
Exclusion
- Patients must not meet the following exclusion criterion during the identification period:
- \- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with lutetium (177Lu) vipivotide tetraxetan
Key Trial Info
Start Date :
September 4 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06517719
Start Date
September 4 2024
End Date
February 1 2028
Last Update
December 30 2025
Active Locations (35)
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1
Novartis Investigative Site
Konstanz, Baden-Wurttemberg, Germany, 78464
2
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, Germany, 70174
3
Novartis Investigative Site
Munich, Bavaria, Germany, 81377
4
Novartis Investigative Site
Regensburg, Bavaria, Germany, 93053