RecruitingNCT07093801

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).

Sponsor

Novartis Pharmaceuticals

Enrollment

300 participants

Start Date

Jul 30, 2025

Study Type

OBSERVATIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

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: MALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is observing how well a radioactive drug treatment called lutetium-177 PSMA (brand name Pluvicto) works in real-world patients with metastatic castration-resistant prostate cancer (prostate cancer that has spread and no longer responds to hormone therapy). Rather than testing a new drug, researchers are collecting information on outcomes in patients already being treated with this approved therapy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with metastatic castration-resistant prostate cancer - Your doctor has already decided to prescribe lutetium-177 PSMA as part of your standard care - You are willing to sign an informed consent form **You may NOT be eligible if...** - You do not meet the standard requirements listed in the drug's official prescribing information (e.g., specific contraindications or criteria set by the Italian medicine agency) - You refuse to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(32)

Novartis Investigative Site

Alessandria, AL, Italy

Novartis Investigative Site

Asti, AT, Italy

Novartis Investigative Site

Bergamo, BG, Italy

Novartis Investigative Site

Brescia, BS, Italy

Novartis Investigative Site

Catania, CT, Italy

Novartis Investigative Site

Meldola, FC, Italy

Novartis Investigative Site

Cona, FE, Italy

Novartis Investigative Site

Foggia, FG, Italy

Novartis Investigative Site

Florence, FI, Italy

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Latina, LT, Italy

Novartis Investigative Site

Province of Macerata, MC, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Rozzano, MI, Italy

Novartis Investigative Site

Palermo, PA, Italy

Novartis Investigative Site

Perugia, PG, Italy

Novartis Investigative Site

Pisa, PI, Italy

Novartis Investigative Site

Aviano, PN, Italy

Novartis Investigative Site

Rionero in Vulture, PZ, Italy

Novartis Investigative Site

Reggio Emilia, RE, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

La Spezia, SP, Italy

Novartis Investigative Site

Torino, TO, Italy

Novartis Investigative Site

Mestre, VE, Italy

Novartis Investigative Site

Negrar, VR, Italy

Novartis Investigative Site

Naples, Italy

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NCT07093801

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