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Recruiting NCT06514521

Post Marketing Study on Pluvicto in Korea

— Observational Metastatic Castration-resistant Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lutetium vipivotide tetraxetan.
Who it may be relevant to
Registry conditions: Metastatic Castration-resistant Prostate Cancer. Basic parameters: 18 years — 100 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

Post marketing study on Pluvicto in Korea

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.

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.

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Objective response rate (ORR) as assessed by investigator [Time frame: 4th±1 week from the last dose]
  • Radiographic progression-free survival (rPFS) [Time frame: Up to 33 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 12 centers
  • Novartis Investigative Site — Seongnam-si
  • Novartis Investigative Site — Suwon
  • Novartis Investigative Site — Busan
  • Novartis Investigative Site — Gyeonggi-do
  • Novartis Investigative Site — Seoul
  • Novartis Investigative Site — Seoul
  • Novartis Investigative Site — Jeollanam
  • Novartis Investigative Site — Seoul
  • … and 4 more centers

Identifiers

NCT: NCT06514521 · CAAA617A1KR01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗