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NCT Number: NCT06514521

Post Marketing Study on Pluvicto in Korea

Post marketing study on Pluvicto in Korea

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Novartis Investigative Site, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

Lutetium vipivotide tetraxetan

Other

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

Other names: Pluvicto

Primary outcomes

  1. Incidence of Adverse Events, Serious Adverse Events, unexpected Adverse Events, Adverse Drug Reactions, Serious Adverse Drug Reactions and unexpected Adverse Drug Reactions

    Time frame: 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.

Secondary outcomes

  1. Objective response rate (ORR) as assessed by investigator

    Time frame: 4th±1 week from the last dose

    Clinical assessment on disease status by investigator will be collected to assess objective response rate (ORR). If results are not available at study schedule, the nearest and available data will be collected. In case of subject follow up loss or discontinuation for any reason, ORR will be assessed based on the data collected at the date of the last contact of the subject.

  2. Radiographic progression-free survival (rPFS)

    Time frame: Up to 33 months

    rPFS, defined as the time from study assignment to the date when the first sign of disease progression or death due to any cause, whichever occurs first.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 23, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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