Post Marketing Study on Pluvicto in Korea

NCT ID: NCT06514521

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

278 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-18

Study Completion Date

2028-05-31

Brief Summary

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Post marketing study on Pluvicto in Korea

Detailed Description

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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.

Conditions

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Metastatic Castration-resistant Prostate Cancer

Keywords

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Metastatic castration-resistant prostate cancer mCRPC PMS RMP Pluvicto Korea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lutetium vipivotide tetraxetan

Patients prescribed with Lutetium vipivotide tetraxetan in real world practice

Lutetium vipivotide tetraxetan

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Pluvicto

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Gyeonggi-do, Korea, South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, Seoul, South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Other Identifiers

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CAAA617A1KR01

Identifier Type: -

Identifier Source: org_study_id