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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | Men only |
| Enrollment | 500 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Locations | 38 sites (Konstanz, Baden-Wurttemberg and 37 other locations) |
| Status | Recruiting |
| Started | September 4, 2024 |
| Main results expected | February 1, 2028 |
| Study ends | February 1, 2028 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT06517719 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
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Novartis Investigative Site
Konstanz, Baden-Wurttemberg, Germany Recruiting -
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Stuttgart, Baden-Wurttemberg, Germany Recruiting -
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Munich, Bavaria, Germany Recruiting -
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Regensburg, Bavaria, Germany Recruiting -
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Würzburg, Bavaria, Germany Recruiting -
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Cottbus, Brandenburg, Germany Recruiting
Show 32 more locations
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Frankfurt (Oder), Brandenburg, Germany Recruiting -
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Ludwigshafen, Germany, Germany Recruiting -
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Marburg, Hesse, Germany Recruiting -
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Cologne, North Rhine-Westphalia, Germany Recruiting -
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Dresden, Saxony, Germany Recruiting -
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Leipzig, Saxony, Germany Recruiting -
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Halle, Saxony-Anhalt, Germany Recruiting -
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Jena, Thuringia, Germany Recruiting -
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Aachen, Germany Recruiting -
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Augsburg, Germany Recruiting -
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Berlin, Germany Recruiting -
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Berlin, Germany Recruiting -
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Berlin, Germany Recruiting -
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Bielefeld, Germany Recruiting -
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Bonn, Germany Recruiting -
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Braunschweig, Germany Recruiting -
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Chemnitz, Germany Recruiting -
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Dortmund, Germany Recruiting -
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Dortmund, Germany Recruiting -
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Erfurt, Germany Recruiting -
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Erlangen, Germany Recruiting -
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Essen, Germany Recruiting -
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Fulda, Germany Recruiting -
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Herford, Germany Recruiting -
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Homburg, Germany Recruiting -
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Magdeburg, Germany Recruiting -
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Mainz, Germany Recruiting -
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Nuremberg, Germany Recruiting -
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Rostock, Germany Recruiting -
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Trier, Germany Recruiting -
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Tübingen, Germany Recruiting -
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Ulm, Germany Recruiting
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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JUR-003 in adults with advanced prostate cancer
This first-in-human study tests JUR-003 to see if it is safe and tolerable and to get an early sense of activity in adults with metastatic or advanced prostate cancer.
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SRT-017 radioligand therapy in PSMA-positive metastatic castration-resistant prostate cancer
This study tests SRT-017 given by IV infusion to men with PSMA-positive metastatic castration-resistant prostate cancer to see if it is safe and tolerable and to gather early signals of anti-tumor activity.
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Rinzimetostat plus darolutamide in metastatic castration-resistant prostate cancer after abiraterone failure
This study tests whether adding rinzimetostat to darolutamide helps people with metastatic castration-resistant prostate cancer who previously took abiraterone.
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FX-111 safety and pharmacokinetics in metastatic castration-resistant prostate cancer
This study tests whether FX-111 is safe and can help treat metastatic castration-resistant prostate cancer in adult men.
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Docetaxel and SX-682 in head and neck cancers and prostate cancer
This trial tests a new drug SX-682 together with docetaxel in adults whose head and neck cancers or prostate cancer have returned or spread.
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Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer
This trial tests ETB-DualNK-01, a dual-target CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer to see if it is safe and shows early signs of activity.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.