Clinical Trials in Italy / NCT07093801
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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