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Lutetium (177Lu) vipivotide tetraxetan for 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).

Observational Novartis · NCT07093801

This project will collect real-world information to see how lutetium (177Lu) vipivotide tetraxetan works in adults with metastatic castration-resistant prostate cancer who are prescribed it.

Quick facts

Study typeObservational
Enrollment300 (estimated)
Ages18 Years to 99 Years
SexMale
SponsorNovartis Industry-sponsored
Locations32 sites (Alessandria, AL and 31 other locations)
Trial IDNCT07093801 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, non-interventional observational project that will collect primary clinical data on patients with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan in routine practice. Patients will be followed from the start of treatment through up to 18 months after the end of treatment to capture outcomes and safety events. Enrollment is limited to adults (≥18) prescribed the drug by their treating physician and who provide informed consent, with eligibility further governed by the local SmPC and the Scheda di Monitoraggio AIFA. The work is sponsored by Novartis and conducted at participating Novartis investigative sites in Alessandria, Asti, and Bergamo, Italy.

Who should consider this trial

Good fit: Adults (≥18) with metastatic castration-resistant prostate cancer who have been prescribed lutetium (177Lu) vipivotide tetraxetan by their treating physician and who can give informed consent are ideal candidates.

Not a fit: Patients who are not prescribed the drug, who have contraindications per the local SmPC or Scheda di Monitoraggio AIFA, who cannot provide informed consent, or who cannot attend the participating sites are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could provide real-world safety and effectiveness information to help doctors and patients make better treatment decisions.

How similar studies have performed: Randomized trials and regulatory approvals for 177Lu-PSMA therapies have shown clinical benefit in similar patient populations, so this observational work builds on established evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Alessandria, AL and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Castration Resistant Prostate Cancerlutetium vipivotide tetraxetan
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.