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Recruiting Observational

Observational Study on Lutetium (177Lu) Vipivotide Tetraxetan to Treat Metastatic Castration Resistant Prostate Cancer

NCT07093801 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-07-30
Last updated
2026-05-15

Condition(s) studied

Metastatic Castration Resistant Prostate Cancer

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Progression-Free Survival (PFS) — up to 18 months post-treatment
    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.

Trial sites (34)

FacilityCityRegionStatus
Novartis Investigative Site Alessandria AL Recruiting
Novartis Investigative Site Asti AT Recruiting
Novartis Investigative Site Bergamo BG Recruiting
Novartis Investigative Site Brescia BS Recruiting
Novartis Investigative Site Catania CT Recruiting
Novartis Investigative Site Meldola FC Recruiting
Novartis Investigative Site Cona FE Recruiting
Novartis Investigative Site Foggia FG Recruiting
Novartis Investigative Site Florence FI Recruiting
Novartis Investigative Site Genova GE Recruiting
Novartis Investigative Site Genova GE Recruiting
Novartis Investigative Site Latina LT Recruiting
Novartis Investigative Site Province of Macerata MC Recruiting
Novartis Investigative Site Milan MI Recruiting
Novartis Investigative Site Milan MI Recruiting
Novartis Investigative Site Rozzano MI Recruiting
Novartis Investigative Site Palermo PA Recruiting
Novartis Investigative Site Padova PD Recruiting
Novartis Investigative Site Perugia PG Recruiting
Novartis Investigative Site Pisa PI Recruiting
Novartis Investigative Site Aviano PN Recruiting
Novartis Investigative Site Rionero in Vulture PZ Recruiting
Novartis Investigative Site Reggio Emilia RE Recruiting
Novartis Investigative Site Roma RM Recruiting
Novartis Investigative Site Roma RM Recruiting
Novartis Investigative Site Roma RM Recruiting
Novartis Investigative Site Roma RM Recruiting
Novartis Investigative Site La Spezia SP Recruiting
Novartis Investigative Site Taranto TA Recruiting
Novartis Investigative Site Torino TO Recruiting
Novartis Investigative Site Mestre VE Recruiting
Novartis Investigative Site Negrar VR Recruiting
Novartis Investigative Site Milan Italy Recruiting
Novartis Investigative Site Naples Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07093801 on ClinicalTrials.gov ↗ ← All trials in Italy