Recruiting

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

NCT06517719 · Novartis

Recruiting

In plain English

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Official title

Real-world Experience With Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, Multicenter, Prospective Cohort Study

About this study

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.

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 design

Enrollment target: 500 participants

Age groups: adult, older_adult

Timeline

Starts: 2024-09-04

Estimated completion: 2028-02-01

Last updated: 2026-07-13

Interventions

Other: lutetium (177Lu) vipivotide tetraxetan

Primary outcomes

• Functional Assessment of Cancer Therapy - Prostate (FACT-P) (Baseline, up to 1 year after end of treatment)
• Change from baseline in FACT-P (Baseline, up to 1 year after end of treatment)
• Functional Assessment of Cancer Therapy-Radionuclid Therapy (FACT-RNT) (Baseline, up to 1 year after end of treatment)

Sponsor

Novartis Pharmaceuticals · industry

Contacts & investigators

ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · +41613241111

ContactNovartis Pharmaceuticals · contact

InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals