Last Update: Jun 17, 2025
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
ClinicalTrials.gov Identifier:
NCT06514521
Novartis Reference Number:CAAA617A1KR01
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

Post marketing study on Pluvicto in Korea This is open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of Pluvicto in patients with mCRPC in the real-world setting in South Korea.

Metastatic Castration-resistant Prostate Cancer
Recruiting
278
Apr 18, 2025
May 31, 2028
Male
18 Years - 100 Years (Adult, Older Adult)

Interventions

Other

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.

Eligibility Criteria

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

Novartis Investigative Site

Recruiting

Seoul,Korea, Republic of

Worldwide Contacts

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Novartis Pharmaceuticals

+41613241111