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Taking peoplePhase 4

Long-Term Safety Follow-Up of Lutetium Vipivotide Tetraxetan in Prostate Cancer

Follows adults with prostate cancer who previously received lutetium vipivotide tetraxetan for long-term side effects.

Plain-language title generated from the registry record
Registry title: Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer

Key facts

Where
Genoa, Milan, Naples, and Rome, ItalySee the 4 sites
Phase
Phase 4

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with prostate cancer who already received at least one dose of AAA617 in a Novartis-sponsored trial. It follows their long-term safety.

Age
18 to 100 years
Sex
Men only
Earlier treatment
Must have received at least one dose of AAA617 in a Novartis-sponsored Phase I-IV trial in prostate cancer.

Main reasons for not taking part

  • People who cannot complete the needed investigational examinations for any reason

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Source: NCT05803941, who can take part

Where in Italy

  • IRCCS Azienda Ospedaliera MetropolitanaGenoa, ItalyNot yet recruiting
  • Istituto Europeo di Oncologia s.r.lMilan, ItalyNot yet recruiting
  • IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyNot yet recruiting
  • I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Novartis Pharmaceuticals
Trial code
NCT05803941EU 2023-503208-94-00
Record updated
4 June 2026
Original description
The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other AAA617 causally related serious adverse event(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.Read full original descriptionShow less

A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer

The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other AAA617 causally related serious adverse event(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.

Inclusion: Signed informed consent must be obtained prior to participation in the study; Must have received at least one dose of AAA617 within an interventional, Phase I-IV Novartis sponsored clinical trial in prostate cancer and have fulfilled the trial's requirements that allows them to participate in this study.

Exclusion: Inability to complete the needed investigational examinations due to any reason.

ClinicalTrials.gov NCT05803941 · EU CTIS 2023-503208-94-00