Last Update: Jul 13, 2026 Real-world Experience With Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, Multicenter, Prospective Cohort Study ClinicalTrials.gov Identifier: [NCT06517719](https://clinicaltrials.gov/ct2/show/NCT06517719) Novartis Reference Number:CAAA617A1DE04 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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. 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. Condition Metastatic Castration Resistant Prostate Cancer Overall Status Recruiting Number of Participants500 Start Date Sep 04, 2024 Completion Date Feb 01, 2028 Gender Male Age(s) 18 Years - 99 Years (Adult, Older Adult) ## Interventions Other ### 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. ## Eligibility 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 Germany #### Novartis Investigative Site Recruiting Erlangen,91054,Germany #### Novartis Investigative Site Recruiting Marburg,Hesse,35043,Germany #### Novartis Investigative Site Recruiting Cologne,North Rhine-Westphalia,50937,Germany #### Novartis Investigative Site Recruiting Dresden,Saxony,01307,Germany #### Novartis Investigative Site Recruiting Leipzig,Saxony,04103,Germany #### Novartis Investigative Site Recruiting Halle,Saxony-Anhalt,06120,Germany #### Novartis Investigative Site Recruiting Jena,Thuringia,07740,Germany #### Novartis Investigative Site Recruiting Berlin,12559,Germany #### Novartis Investigative Site Recruiting Dortmund,44137,Germany #### Novartis Investigative Site Recruiting Dortmund,44309,Germany #### Novartis Investigative Site Recruiting Ludwigshafen,Germany,67063,Germany #### Novartis Investigative Site Recruiting Fulda,36043,Germany #### Novartis Investigative Site Recruiting Herford,32049,Germany #### Novartis Investigative Site Recruiting Homburg,66421,Germany #### Novartis Investigative Site Recruiting Mainz,55131,Germany #### Novartis Investigative Site Recruiting Rostock,18057,Germany #### Novartis Investigative Site Recruiting Nuremberg,90419,Germany #### Novartis Investigative Site Recruiting Erfurt,99089,Germany #### Novartis Investigative Site Recruiting Braunschweig,38114,Germany #### Novartis Investigative Site Recruiting Trier,54290,Germany #### Novartis Investigative Site Recruiting Berlin,13125,Germany #### Novartis Investigative Site Recruiting Essen,45147,Germany #### Novartis Investigative Site Recruiting Regensburg,Bavaria,93053,Germany #### Novartis Investigative Site Recruiting Aachen,52074,Germany #### Novartis Investigative Site Recruiting Bielefeld,33611,Germany #### Novartis Investigative Site Recruiting Bonn,53105,Germany #### Novartis Investigative Site Recruiting Chemnitz,09113,Germany #### Novartis Investigative Site Recruiting Magdeburg,39120,Germany #### Novartis Investigative Site Recruiting Augsburg,86179,Germany #### Novartis Investigative Site Recruiting Berlin,10249,Germany #### Novartis Investigative Site Recruiting Ulm,89081,Germany #### Novartis Investigative Site Recruiting Konstanz,Baden-Wurttemberg,78464,Germany #### Novartis Investigative Site Recruiting Tübingen,72076,Germany #### Novartis Investigative Site Recruiting Stuttgart,Baden-Wurttemberg,70174,Germany #### Novartis Investigative Site Recruiting Munich,Bavaria,81377,Germany #### Novartis Investigative Site Recruiting Würzburg,Bavaria,97080,Germany #### Novartis Investigative Site Recruiting Cottbus,Brandenburg,03048,Germany #### Novartis Investigative Site Recruiting Frankfurt (Oder),Brandenburg,15236,Germany ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: