Long-Term Safety of lutetium (177Lu) vipivotide tetraxetan in Participants with Prostate Cancer
Research type
Research Study
Full title
A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of lutetium (177Lu) vipivotide tetraxetan in Adult Participants with Prostate Cancer
IRAS ID
1008340
Contact name
Daniel Monney
Contact email
Sponsor organisation
Novartis Pharma AG
Research 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 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. Participants will be in the study for up to 10 years from the first dose of AAA617 they received as part of their participation in the previous treatment study. During that time, participants will need to visit the Study Doctor at the study site every 6 to 8 months.
Participants will not receive any study drug during this study as this is a long-term follow-up for the study drug AAA617 participants received in the previous study.
Approximately 698 participants worldwide will participate in this study, in 227 sites and 22 countries.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0210
Date of REC Opinion
11 Oct 2023
REC opinion
Further Information Favourable Opinion