A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of lutetium (177-Lu) 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 serious adverse reaction(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.
Main Inclusion/Exclusion:
- 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
- Willingness of sexually active participant to use a condom during intercourse for up to 14 weeks from the last dose of AAA617 treatment administered on parent study.
Indications:
- Target Population includes all adult prostate cancer patients who have received at least one dose of AAA617 in the context of an interventional, Phase I-IV Novartis Sponsored clinical trial (Parent Treatment Study)
Contact: cajwciclinicaltrials@providence.org