Clinical trial Recruiting at 38 sites Observational Ages 18 to 99 Men only

Evaluating the use of lutetium vipivotide tetraxetan in advanced prostate cancer

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

Run by Novartis · NCT06517719 · Data updated 2026-11-12

This study is trying to see how the treatment lutetium vipivotide tetraxetan affects the quality of life for men with advanced prostate cancer over the course of their treatment and follow-up.

More Metastatic Castration-resistant Prostate Cancer trials

Quick facts

Study typeObservational
Ages18 Years to 99 Years
SexMen only
Enrollment500 (estimated)
SponsorNovartis
Industry-sponsored
Locations38 sites (Konstanz, Baden-Wurttemberg and 37 other locations)
StatusRecruiting
StartedSeptember 4, 2024
Main results expectedFebruary 1, 2028
Study endsFebruary 1, 2028
Registry record updatedJuly 13, 2026
Trial IDNCT06517719 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adult males diagnosed with metastatic castration-resistant prostate cancer who are initiating treatment with lutetium (177Lu) vipivotide tetraxetan.

Probably not a fit

Patients currently participating in other investigational trials or non-interventional studies involving lutetium (177Lu) vipivotide tetraxetan may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather real-world data on the use of lutetium (177Lu) vipivotide tetraxetan in patients with metastatic castration-resistant prostate cancer (mCRPC). It will assess health-related quality of life (HRQoL) at various stages: before treatment, during treatment, at the end of treatment, and during follow-up. Data will be collected through patient questionnaires over a period of up to one year after treatment. The study will involve adult male patients who are starting this treatment as per their physician's decision.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the quality of life improvements for patients undergoing treatment for mCRPC.

How similar studies have gone: While this study focuses on real-world data collection, similar approaches in other studies have shown promise in understanding treatment impacts on quality of life.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Novartis Investigative Site
    Konstanz, Baden-Wurttemberg, Germany
    Recruiting
  • Novartis Investigative Site
    Stuttgart, Baden-Wurttemberg, Germany
    Recruiting
  • Novartis Investigative Site
    Munich, Bavaria, Germany
    Recruiting
  • Novartis Investigative Site
    Regensburg, Bavaria, Germany
    Recruiting
  • Novartis Investigative Site
    Würzburg, Bavaria, Germany
    Recruiting
  • Novartis Investigative Site
    Cottbus, Brandenburg, Germany
    Recruiting
Show 32 more locations
  • Novartis Investigative Site
    Frankfurt (Oder), Brandenburg, Germany
    Recruiting
  • Novartis Investigative Site
    Ludwigshafen, Germany, Germany
    Recruiting
  • Novartis Investigative Site
    Marburg, Hesse, Germany
    Recruiting
  • Novartis Investigative Site
    Cologne, North Rhine-Westphalia, Germany
    Recruiting
  • Novartis Investigative Site
    Dresden, Saxony, Germany
    Recruiting
  • Novartis Investigative Site
    Leipzig, Saxony, Germany
    Recruiting
  • Novartis Investigative Site
    Halle, Saxony-Anhalt, Germany
    Recruiting
  • Novartis Investigative Site
    Jena, Thuringia, Germany
    Recruiting
  • Novartis Investigative Site
    Aachen, Germany
    Recruiting
  • Novartis Investigative Site
    Augsburg, Germany
    Recruiting
  • Novartis Investigative Site
    Berlin, Germany
    Recruiting
  • Novartis Investigative Site
    Berlin, Germany
    Recruiting
  • Novartis Investigative Site
    Berlin, Germany
    Recruiting
  • Novartis Investigative Site
    Bielefeld, Germany
    Recruiting
  • Novartis Investigative Site
    Bonn, Germany
    Recruiting
  • Novartis Investigative Site
    Braunschweig, Germany
    Recruiting
  • Novartis Investigative Site
    Chemnitz, Germany
    Recruiting
  • Novartis Investigative Site
    Dortmund, Germany
    Recruiting
  • Novartis Investigative Site
    Dortmund, Germany
    Recruiting
  • Novartis Investigative Site
    Erfurt, Germany
    Recruiting
  • Novartis Investigative Site
    Erlangen, Germany
    Recruiting
  • Novartis Investigative Site
    Essen, Germany
    Recruiting
  • Novartis Investigative Site
    Fulda, Germany
    Recruiting
  • Novartis Investigative Site
    Herford, Germany
    Recruiting
  • Novartis Investigative Site
    Homburg, Germany
    Recruiting
  • Novartis Investigative Site
    Magdeburg, Germany
    Recruiting
  • Novartis Investigative Site
    Mainz, Germany
    Recruiting
  • Novartis Investigative Site
    Nuremberg, Germany
    Recruiting
  • Novartis Investigative Site
    Rostock, Germany
    Recruiting
  • Novartis Investigative Site
    Trier, Germany
    Recruiting
  • Novartis Investigative Site
    Tübingen, Germany
    Recruiting
  • Novartis Investigative Site
    Ulm, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.