Observational Study on Lutetium (177Lu) Vipivotide Tetraxetan to Treat Metastatic Castration Resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Metastatic Castration Resistant Prostate Cancer. Basic parameters: 18 years — 99 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-world Experience of Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, National, Multicenter, Prospective Cohort Study (PLU4REAL).
Overview
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.
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: up to 18 months post-treatment]
Secondary outcome measures (12)
- Second Progression-Free Survival (PFS2) [Time frame: up to 18 months post-treatment]
- Overall Survival (OS) [Time frame: up to 18 months post-treatment]
- Prostate-Specific Antigen (PSA) response rates (RR) [Time frame: up to 18 months post-treatment]
- Overall Response Rate (ORR) [Time frame: up to 18 months post treatment]
- Duration of Response (DoR) [Time frame: up to 18 months post-treatment]
- Proportion of patients with SSE and time to event [Time frame: up to 18 months post-treatment]
- Time to initiation of pain medication [Time frame: from start of treatment to up to 18 months post-treatment]
- Change of pain medication [Time frame: from baseline to up to 18 months post treatment]
- HRQoL - Functional Assessment of Cancer Therapy-Prostate (FACT-P) [Time frame: from cycle 1 up to 18 months post treatment]
- HRQoL - Brief Pain Inventory - Short Form (BPI-SF) [Time frame: from cycle 1 up to 18 months post treatment]
- HRQoL - Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT) [Time frame: from cycle 1 up to 18 months post treatment]
- Correlation between baseline clinical and molecular characteristics and and treatment outcomes [Time frame: from baseline to up to 18 months post treatment]
Eligibility criteria
- Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan by the treating physician (Multidisciplinary Team).
- ≥ 18 years old at the time of enrollment.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 34 centers
- Novartis Investigative Site — Alessandria
- Novartis Investigative Site — Asti
- Novartis Investigative Site — Bergamo
- Novartis Investigative Site — Brescia
- Novartis Investigative Site — Catania
- Novartis Investigative Site — Meldola
- Novartis Investigative Site — Cona
- Novartis Investigative Site — Foggia
- … and 26 more centers
Identifiers
NCT: NCT07093801 · CAAA617A1IT01