At a glance
ClinicalIndex Comparison Record- ✓Signed informed consent prior to study participation
- ✓Prior AAA617 treatment in Novartis-sponsored Phase I-IV prostate cancer trial
- ✓Met prior trial requirements allowing continuation to this study
- ✕Unable to complete required investigational examinations
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer
In Brief
A Phase 4 clinical trial evaluating AAA617 for Prostate Cancer. Currently recruiting, targeting 700 participants across 54 sites in 11 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Participants will be followed until death, lost to follow-up, or up to 10 years from first dose of AAA617, whichever occurs first. There will be no study treatment administered to participants while participating in this study.
Interventions
Long-term follow-up (LTFU) safety study of adult participants with prostate cancer that have received at least one dose of AAA617 from parent interventional Novartis sponsored clinical trials.