Post Marketing Study on Pluvicto in Korea

Novartis Pharmaceuticals278 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

278

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

Lutetium vipivotide tetraxetanOTHER

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

Sex: MALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (12)

Novartis Investigative Site

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

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.

Time frame: Until 30 days after the last dose of Pluvicto, up to 33 months

Secondary Outcomes

Objective response rate (ORR) as assessed by investigator

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.

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

Radiographic progression-free survival (rPFS)

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.

Time frame: Up to 33 months

Central Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.