A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer
Novartis Pharmaceuticals
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.
Description
This is a global, prospective, multi-center, long-term follow-up (LTFU) safety study of adult participants with prostate cancer that have received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials. There will be no study treatment administered to participants in this study. Participants will have visits every 6-8 months for monitoring of selected AEs and laboratory parameters. The study periods include a Baseline and Follow-up Period (up to 10 years after first dose of AAA617 in parent treatment study). Participants should enroll into the LTFU stu…
Eligibility
- Age range
- 18–100 years
- Sex
- Male
- Healthy volunteers
- No
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.
Interventions
- DrugAAA617
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.
Locations (54)
- Mayo Clinic ArizonaScottsdale, Arizona
- St. Joseph HospitalOrange, California
- Providence Saint Johns Health CtrSanta Monica, California
- University of ColoradoAurora, Colorado
- Hartford HospitalHartford, Connecticut
- VA Medical CenterWashington D.C., District of Columbia