Observational Study on Lutetium (177Lu) Vipivotide Tetraxetan to Treat Metastatic Castration Resistant Prostate Cancer
Real-world Experience of Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, National, Multicenter, Prospective Cohort Study (PLU4REAL).
1 other identifier
observational
300
1 country
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2025
Typical duration for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2025
CompletedFirst Posted
Study publicly available on registry
July 30, 2025
CompletedStudy Start
First participant enrolled
July 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2029
February 20, 2026
February 1, 2026
3.7 years
July 9, 2025
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
Defined as the time from date of initiation of lutetium (177Lu) vipivotide tetraxetan to the date of first documented progression by investigator assessment (radiographic progression according to the most recent version of Prostate Cancer Working Group \[PCWG\] or Response Evaluation Criteria In PSMA-PET/CT \[RECIP\] 1.0, clinical progression, Prostate Specific Antigen \[PSA\] progression) or death from any cause, whichever occurs first up to 18 months post-treatment.
up to 18 months post-treatment
Secondary Outcomes (16)
Second Progression-Free Survival (PFS2)
up to 18 months post-treatment
Overall Survival (OS)
up to 18 months post-treatment
Prostate-Specific Antigen (PSA) response rates (RR)
up to 18 months post-treatment
Overall Response Rate (ORR)
up to 18 months post treatment
Duration of Response (DoR)
up to 18 months post-treatment
- +11 more secondary outcomes
Study Arms (1)
Patients diagnosed with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan
Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan by the treating physician (Multidisciplinary Team).
Eligibility Criteria
Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Novartis Investigative Site
Alessandria, AL, 15121, Italy
Novartis Investigative Site
Asti, AT, 14100, Italy
Novartis Investigative Site
Bergamo, BG, 24127, Italy
Novartis Investigative Site
Brescia, BS, 25123, Italy
Novartis Investigative Site
Catania, CT, 95123, Italy
Novartis Investigative Site
Meldola, FC, 47014, Italy
Novartis Investigative Site
Cona, FE, 44124, Italy
Novartis Investigative Site
Foggia, FG, 71122, Italy
Novartis Investigative Site
Florence, FI, 50134, Italy
Novartis Investigative Site
Genova, GE, 16128, Italy
Novartis Investigative Site
Genova, GE, 16132, Italy
Novartis Investigative Site
Latina, LT, 04100, Italy
Novartis Investigative Site
Macerata, MC, 62100, Italy
Novartis Investigative Site
Milan, MI, 20133, Italy
Novartis Investigative Site
Milan, MI, 20141, Italy
Novartis Investigative Site
Milan, MI, 20162, Italy
Novartis Investigative Site
Rozzano, MI, 20089, Italy
Novartis Investigative Site
Palermo, PA, 90146, Italy
Novartis Investigative Site
Perugia, PG, 06129, Italy
Novartis Investigative Site
Pisa, PI, 56126, Italy
Novartis Investigative Site
Aviano, PN, 33081, Italy
Novartis Investigative Site
Rionero in Vulture, PZ, 85028, Italy
Novartis Investigative Site
Reggio Emilia, RE, 42123, Italy
Novartis Investigative Site
Roma, RM, 00128, Italy
Novartis Investigative Site
Roma, RM, 00152, Italy
Novartis Investigative Site
Roma, RM, 00168, Italy
Novartis Investigative Site
Roma, RM, 00189, Italy
Novartis Investigative Site
La Spezia, SP, 19121, Italy
Novartis Investigative Site
Torino, TO, 10128, Italy
Novartis Investigative Site
Mestre, VE, 30174, Italy
Novartis Investigative Site
Negrar, VR, 37024, Italy
Novartis Investigative Site
Naples, 80131, Italy
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Novartis Pharmaceuticals
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2025
First Posted
July 30, 2025
Study Start
July 30, 2025
Primary Completion (Estimated)
March 30, 2029
Study Completion (Estimated)
March 30, 2029
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share