Lutetium 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.
Study summary
Post marketing study on Pluvicto in Korea
Eligibility
Sex
MALE
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion criteria
Study participants eligible for inclusion in this study must meet all of the following criteria:
1. Male adult patient age ≥ 18
2. 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
3. Subject who provided the written informed consent prior to the study enrollment
Exclusion criteria
Study participants meeting any of the following criteria are not eligible for inclusion in this study:
1. Subject whose medical record is not accessible
2. Subject who is not willing to provide the informed consent
Primary outcome measure(s)
Incidence of Adverse Events, Serious Adverse Events, unexpected Adverse Events, Adverse Drug Reactions, Serious Adverse Drug Reactions and unexpected Adverse Drug Reactions — Until 30 days after the last dose of Pluvicto, up to 33 months The safety assessment will consist of occurrence status of all adverse events (AEs)/adverse drug reactions (ADRs), serious AEs (SAEs)/serious ADRs and unexpected AEs/unexpected ADRs.
Safety data will be collected from all subjects over the study period. Subjects will be followed up for AEs until 30 days after the last dose of Pluvicto.
Trial sites (12)
Facility
City
Region
Status
Novartis Investigative Site
Seongnam-si
Gyeonggi-do
Recruiting
Novartis Investigative Site
Suwon
Gyeonggi-do
Recruiting
Novartis Investigative Site
Busan
Korea
Recruiting
Novartis Investigative Site
Gyeonggi-do
Korea
Recruiting
Novartis Investigative Site
Seoul
Seoul
Recruiting
Novartis Investigative Site
Seoul
Seoul
Recruiting
Novartis Investigative Site
Jeollanam
South Korea
Recruiting
Novartis Investigative Site
Seoul
South Korea
Recruiting
Novartis Investigative Site
Seoul
South Korea
Recruiting
Novartis Investigative Site
Seoul
South Korea
Recruiting
Novartis Investigative Site
Seoul
South Korea
Recruiting
Novartis Investigative Site
Seoul
South Korea
Recruiting
More Novartis Pharmaceuticals trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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