← Back to Clinical Trials
Recruiting Phase 4 NCT05803941

Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer

Trial Parameters

Condition Prostate Cancer
Sponsor Novartis Pharmaceuticals
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 700
Sex MALE
Min Age 18 Years
Max Age 100 Years
Start Date 2023-08-14
Completion 2033-07-20
Interventions
AAA617

Brief Summary

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.

Eligibility Criteria

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

Related Trials