RecruitingNCT06514521

Post Marketing Study on Pluvicto in Korea

A Post Marketing Surveillance on PluvictoTM (Lutetium(177Lu) Vipivotide Tetraxetan) in South Korea; An Open-label, Non-interventional, Primary Data Collection, Multi-center, Non-comparative, Non-randomized Observational Study to Assess Safety and Effectiveness of Pluvicto in Real World Setting

Sponsor

Novartis Pharmaceuticals

Enrollment

278 participants

Start Date

Apr 18, 2025

Study Type

OBSERVATIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

Summary

Post marketing study on Pluvicto in Korea

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Inclusion Criteria4

Study participants eligible for inclusion in this study must meet all of the following criteria:
Male adult patient age ≥ 18
Subject who are being treated with Pluvicto or whose treatment plan is finalized and scheduled to be administered at the time of consent by physician in accordance with the approved indication in South Korea
Subject who provided the written informed consent prior to the study enrollment

Exclusion Criteria3

Study participants meeting any of the following criteria are not eligible for inclusion in this study:
Subject whose medical record is not accessible
Subject who is not willing to provide the informed consent

Interventions

OTHERLutetium vipivotide tetraxetan

This is an observational study. There is no treatment allocation. The decision to initiate Lutetium vipivotide tetraxetan will be based solely on clinical judgement.