RecruitingNCT06517719

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

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


Sponsor

Novartis Pharmaceuticals

Enrollment

500 participants

Start Date

Sep 4, 2024

Study Type

OBSERVATIONAL

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • 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 Criteria2

  • 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

Interventions

OTHERlutetium (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.


Locations(35)

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

Novartis Investigative Site

Dresden, Saxony, Germany

Novartis Investigative Site

Leipzig, Saxony, Germany

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany

Novartis Investigative Site

Jena, Thuringia, Germany

Novartis Investigative Site

Aachen, Germany

Novartis Investigative Site

Augsburg, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Bielefeld, Germany

Novartis Investigative Site

Bonn, Germany

Novartis Investigative Site

Chemnitz, Germany

Novartis Investigative Site

Dortmund, Germany

Novartis Investigative Site

Dortmund, Germany

Novartis Investigative Site

Erlangen, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Fulda, Germany

Novartis Investigative Site

Herford, Germany

Novartis Investigative Site

Homburg, Germany

Novartis Investigative Site

Magdeburg, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Rostock, Germany

Novartis Investigative Site

Trier, Germany

Novartis Investigative Site

Tübingen, Germany

Novartis Investigative Site

Ulm, Germany

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NCT06517719