Observational Study of Pluvicto Lutetium177Lu Vipivotide Tetraxetan for Metastatic Castration-Resistant Prostate Cancer in South Korea

What this Trial Is About

This research aims to observe the safety and effectiveness of Pluvicto in adult male patients with metastatic castration-resistant prostate cancer mCRPC in South Korea. It is an open-label, multi-center, non-comparative, and non-interventional observational study conducted in real-world clinical settings. The study focuses on collecting primary data without altering standard patient care. Participants in this study include male adults aged 18 to 100 who are prescribed Lutetium vipivotide tetraxetan Pluvicto based on clinical judgment by their physicians. There is no randomization or treatment allocation, as the study observes patients already scheduled or currently receiving Pluvicto. The study does not interfere with treatment decisions but collects information during routine care. During the study, researchers will monitor and record adverse events and drug reactions up to 30 days after the last Pluvicto dose, spanning up to 33 months. They will also assess the objective response rate about four weeks after the last dose and follow radiographic progression-free survival for up to 33 months. Participants will undergo regular assessments during treatment and follow-up periods to track safety and effectiveness outcomes.

Post Marketing Study on Pluvicto in Korea