Study Description
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.
Interventions
lutetium (177Lu) vipivotide tetraxetan
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Study Location
Novartis Investigative Site
Recruiting
Essen,45147,Germany
Novartis Investigative Site
Recruiting
Halle S,06120,Germany
Novartis Investigative Site
Recruiting
Konstanz,Baden Wuerttemberg,78464,Germany
Novartis Investigative Site
Recruiting
Berlin,10249,Germany
Novartis Investigative Site
Recruiting
Berlin,13125,Germany
Worldwide Contacts
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