Educational guide
A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of lutetium (177Lu) vipivotide tetraxetan in Adult Participants with Prostate Cancer | Cleveland Clinic
IRB Study Number 23-1120 Status Recruiting Institute Taussig Cancer Institute Description Primary objective(s) ● Further characterize the long-term outcome (for up to 10 years after the first dose of AAA617) of 1) known or potential risks of AAA617 including m
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IRB Study Number 23-1120
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary objective(s)
● Further characterize the long-term outcome (for up to 10 years after the first dose of AAA617) of 1) known or potential risks of AAA617 including myelosuppression, renal failure, xerostomia, xerophthalmia, and secondary malignancies including myelodysplastic syndrome and acute myeloid leukemia (MDS/AML) and 2) other AAA617 causally related serious adverse events
Secondary objective(s)
● Evaluate incidence of death
● Determine if the dosimetry estimates in kidney and selected organs (when collected in the parent treatment studies) are associated with any long-term safety events of AAA617
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.