Informations générales (source: ClinicalTrials.gov)
A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer
Interventional
Phase 4
Novartis Pharmaceuticals (Voir sur ClinicalTrials)
août 2023
juillet 2033
25 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Camilo GARCIA | 27/04/2026 08:20:06 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Novartis Investigative Site - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Homme
Inclusion Criteria:
- 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.
- 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.
- Inability to complete the needed investigational examinations due to any reason.