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

NCT ID: NCT06517719

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-04

Study Completion Date

2028-02-01

Brief Summary

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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

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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.

Conditions

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Metastatic Castration Resistant Prostate Cancer

Keywords

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metastatic castration resistant prostate cancer mCRPC Prostate cancer lutetium vipivotide tetraxetan 177Lu

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lutetium (177Lu) vipivotide tetraxetan

Patients with mCRPC initiating lutetium (177Lu) vipivotide tetraxetan

lutetium (177Lu) vipivotide tetraxetan

Intervention Type OTHER

This is an observational study. There is no treatment allocation. The decision to initiate lutetium vipivotide tetraxetan will be based solely on clinical judgement.

Interventions

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lutetium (177Lu) vipivotide tetraxetan

This is an observational study. There is no treatment allocation. The decision to initiate lutetium vipivotide tetraxetan will be based solely on clinical judgement.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Konstanz, Baden-Wurttemberg, Germany

Site Status RECRUITING

Novartis Investigative Site

Stuttgart, Baden-Wurttemberg, Germany

Site Status RECRUITING

Novartis Investigative Site

Munich, Bavaria, Germany

Site Status RECRUITING

Novartis Investigative Site

Regensburg, Bavaria, Germany

Site Status RECRUITING

Novartis Investigative Site

Würzburg, Bavaria, Germany

Site Status RECRUITING

Novartis Investigative Site

Cottbus, Brandenburg, Germany

Site Status RECRUITING

Novartis Investigative Site

Frankfurt (Oder), Brandenburg, Germany

Site Status RECRUITING

Novartis Investigative Site

Ludwigshafen, Germany, Germany

Site Status RECRUITING

Novartis Investigative Site

Marburg, Hesse, Germany

Site Status RECRUITING

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Novartis Investigative Site

Dresden, Saxony, Germany

Site Status RECRUITING

Novartis Investigative Site

Leipzig, Saxony, Germany

Site Status RECRUITING

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany

Site Status RECRUITING

Novartis Investigative Site

Jena, Thuringia, Germany

Site Status RECRUITING

Novartis Investigative Site

Aachen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Augsburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Bielefeld, , Germany

Site Status RECRUITING

Novartis Investigative Site

Bonn, , Germany

Site Status RECRUITING

Novartis Investigative Site

Chemnitz, , Germany

Site Status RECRUITING

Novartis Investigative Site

Dortmund, , Germany

Site Status RECRUITING

Novartis Investigative Site

Dortmund, , Germany

Site Status RECRUITING

Novartis Investigative Site

Erlangen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Essen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Fulda, , Germany

Site Status RECRUITING

Novartis Investigative Site

Herford, , Germany

Site Status RECRUITING

Novartis Investigative Site

Homburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Magdeburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Mainz, , Germany

Site Status RECRUITING

Novartis Investigative Site

Rostock, , Germany

Site Status RECRUITING

Novartis Investigative Site

Trier, , Germany

Site Status RECRUITING

Novartis Investigative Site

Tübingen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Ulm, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Other Identifiers

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CAAA617A1DE04

Identifier Type: -

Identifier Source: org_study_id