This clinical trial is focused on studying the long-term safety of a treatment for prostate cancer. The treatment being investigated is called lutetium (177Lu) vipivotide tetraxetan, also known by its code name AAA617. This medication is given as a solution for injection or infusion, which means it is administered directly into the bloodstream through a vein. The purpose of the study is to gather more information about the long-term effects of this treatment, especially any known or potential risks.
Participants in this study will be monitored for up to 10 years after receiving their first dose of the treatment. The study aims to observe any side effects, such as myelosuppression (a condition where bone marrow activity is decreased, leading to fewer blood cells), renal failure (a condition where the kidneys stop working properly), xerostomia (dry mouth), xerophthalmia (dry eyes), and the development of other serious conditions like myelodysplastic syndrome and acute myeloid leukemia. The study will also look for any other serious adverse reactions that may occur.
Throughout the study, researchers will collect data on the incidence and proportion of participants experiencing these side effects, as well as any changes in laboratory values. The study will also track the incidence and proportion of deaths among participants. This information will help to better understand the long-term safety of lutetium (177Lu) vipivotide tetraxetan in treating prostate cancer.



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