Long-Term Safety Study of Lutetium 177Lu Vipivotide Tetraxetan in Adults With Prostate Cancer Who Received AAA617

What this Trial Is About

Researchers are studying the long-term safety of lutetium 177Lu vipivotide tetraxetan, also called AAA617 or 177Lu-PSMA-617, in adult men with prostate cancer. This post-marketing Phase IV study aims to better understand the lasting effects and possible serious side effects of AAA617 in those who have received it in prior Novartis clinical trials. The focus is on monitoring known or potential risks over many years. Participants have already received at least one dose of AAA617 in earlier clinical trials and will join this long-term follow-up study without receiving any new treatments. The study involves visits every 6 to 8 months for up to 10 years after the first dose of AAA617, with no study treatment given during this time. The number of visits depends on when participants enroll following their initial treatment. During each visit, researchers will monitor selected side effects and laboratory tests to track safety outcomes. The main measurements include the number and percentage of participants experiencing selected adverse events and serious adverse events. They will also record deaths and measure radiation doses in organs like the kidney. Participants will be followed until death, lost to follow-up, or completion of 10 years from first AAA617 dose, whichever comes first.

Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer