Last Update: May 15, 2026 Real-world Experience of Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, National, Multicenter, Prospective Cohort Study (PLU4REAL). ClinicalTrials.gov Identifier: [NCT07093801](https://clinicaltrials.gov/ct2/show/NCT07093801) Novartis Reference Number:CAAA617A1IT01 [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 This is a local prospective, multicenter, long-term, non-interventional study using primary data collection to describe the routine clinical practice of patients with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan. The observation period will be from date of start of treatment up to a maximum of 18 months after end of treatment. Condition Metastatic Castration Resistant Prostate Cancer Overall Status Recruiting Number of Participants300 Start Date Jul 30, 2025 Completion Date Mar 30, 2029 Gender Male Age(s) 18 Years - 99 Years (Adult, Older Adult) ## Eligibility Criteria 1\. Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan by the treating physician (Multidisciplinary Team). 2\. ≥ 18 years old at the time of enrollment. 3\. Written informed consent must be obtained to participate to this study In addition to the above-listed criteria, no other inclusion/exclusion criteria exist other than the requirements stated in the local Summary of Product Characteristics (SmPC) and in the "Scheda di Monitoraggio AIFA", e.g., contraindications. Italy #### Novartis Investigative Site Recruiting Alessandria,AL,15121,Italy #### Novartis Investigative Site Recruiting Torino,TO,10128,Italy #### Novartis Investigative Site Recruiting Asti,AT,14100,Italy #### Novartis Investigative Site Recruiting Bergamo,BG,24127,Italy #### Novartis Investigative Site Recruiting Foggia,FG,71122,Italy #### Novartis Investigative Site Recruiting Genova,GE,16128,Italy #### Novartis Investigative Site Recruiting Roma,RM,00128,Italy #### Novartis Investigative Site Recruiting Mestre,VE,30174,Italy #### Novartis Investigative Site Recruiting Negrar,VR,37024,Italy #### Novartis Investigative Site Recruiting La Spezia,SP,19121,Italy #### Novartis Investigative Site Recruiting Meldola,FC,47014,Italy #### Novartis Investigative Site Recruiting Aviano,PN,33081,Italy #### Novartis Investigative Site Recruiting Naples,80131,Italy #### Novartis Investigative Site Recruiting Province of Macerata,MC,62100,Italy #### Novartis Investigative Site Recruiting Padova,PD,35128,Italy #### Novartis Investigative Site Recruiting Taranto,TA,74100,Italy #### Novartis Investigative Site Recruiting Milan,20141,Italy #### Novartis Investigative Site Recruiting Palermo,PA,90146,Italy #### Novartis Investigative Site Recruiting Catania,CT,95123,Italy #### Novartis Investigative Site Recruiting Cona,FE,44124,Italy #### Novartis Investigative Site Recruiting Florence,FI,50134,Italy #### Novartis Investigative Site Recruiting Genova,GE,16132,Italy #### Novartis Investigative Site Recruiting Latina,LT,04100,Italy #### Novartis Investigative Site Recruiting Milan,MI,20133,Italy #### Novartis Investigative Site Recruiting Milan,MI,20162,Italy #### Novartis Investigative Site Recruiting Rozzano,MI,20089,Italy #### Novartis Investigative Site Recruiting Brescia,BS,25123,Italy #### Novartis Investigative Site Recruiting Perugia,PG,06129,Italy #### Novartis Investigative Site Recruiting Pisa,PI,56126,Italy #### Novartis Investigative Site Recruiting Rionero in Vulture,PZ,85028,Italy #### Novartis Investigative Site Recruiting Reggio Emilia,RE,42123,Italy #### Novartis Investigative Site Recruiting Roma,RM,00152,Italy #### Novartis Investigative Site Recruiting Roma,RM,00168,Italy #### Novartis Investigative Site Recruiting Roma,RM,00189,Italy ## 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: