Evaluating the use of lutetium vipivotide tetraxetan in advanced prostate cancer
Real-world Experience With Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, Multicenter, Prospective Cohort Study
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Male |
| Sponsor | Novartis Industry-sponsored |
| Locations | 36 sites (Konstanz, Baden-Wurttemberg and 35 other locations) |
| Trial ID | NCT06517719 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult males diagnosed with metastatic castration-resistant prostate cancer who are initiating treatment with lutetium (177Lu) vipivotide tetraxetan.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Konstanz, Baden-Wurttemberg and 35 other locations
- 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)
- 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 — Chemnitz, Germany (Recruiting)
- Novartis Investigative Site — Dortmund, Germany (Recruiting)
- Novartis Investigative Site — Dortmund, 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
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.