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Real-world Experience With Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, Multicenter, Prospective Cohort Study
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.
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.
Age
18 - 99 years
Sex
MALE
Healthy Volunteers
No
Novartis Investigative Site
Konstanz, Baden-Wurttemberg, Germany
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, Germany
Novartis Investigative Site
Munich, Bavaria, Germany
Novartis Investigative Site
Regensburg, Bavaria, Germany
Novartis Investigative Site
Würzburg, Bavaria, Germany
Novartis Investigative Site
Cottbus, Brandenburg, Germany
Novartis Investigative Site
Frankfurt (Oder), Brandenburg, Germany
Novartis Investigative Site
Ludwigshafen, Germany, Germany
Novartis Investigative Site
Marburg, Hesse, Germany
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
Start Date
September 4, 2024
Primary Completion Date
February 1, 2028
Completion Date
February 1, 2028
Last Updated
December 30, 2025
500
ESTIMATED participants
lutetium (177Lu) vipivotide tetraxetan
OTHER
Novartis Pharmaceuticals
CONTACT
Lead Sponsor
Novartis Pharmaceuticals
NCT07285694
NCT06830850
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06609005