Post Marketing Study on Pluvicto in Korea

May 28, 2026 updated by: Novartis Pharmaceuticals

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

Post marketing study on Pluvicto in Korea

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

278

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • South Korea
      • Seoul, South Korea, 05505
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 06591
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 03722
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 110-744
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 01812
        • Recruiting
        • Novartis Investigative Site
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Novartis Investigative Site
      • Suwon, Gyeonggi-do, South Korea, 442-723
        • Recruiting
        • Novartis Investigative Site
    • Korea
      • Busan, Korea, South Korea, 46033
        • Recruiting
        • Novartis Investigative Site
      • Gyeonggi-do, Korea, South Korea, 10408
        • Recruiting
        • Novartis Investigative Site
    • Seoul
      • Seoul, Seoul, South Korea, 06351
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Seoul, South Korea, 03374
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have been using or going to receive Pluvicto per clinical judgment under routine medical practice are eligible for the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lutetium vipivotide tetraxetan
Patients prescribed with Lutetium vipivotide tetraxetan in real world practice
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.
Other Names:
  • Pluvicto

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until 30 days after the last dose of Pluvicto, up to 33 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4th±1 week from the last dose
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.
Up to 33 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2025

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAA617A1KR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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