Post Marketing Study on Pluvicto in Korea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
Post marketing study on Pluvicto in Korea
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Subject whose medical record is not accessible
Subject who is not willing to provide the informed consent
Trial population
Patients who have been using or going to receive Pluvicto per clinical judgment under routine medical practice are eligible for the study
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Lutetium vipivotide tetraxetan
Other interventionThis is an observational study. There is no treatment allocation. The decision to initiate Lutetium vipivotide tetraxetan will be based solely on clinical judgement.
Treatment groups
278 Participants
are divided into 1 treatment groupGroup A: Lutetium vipivotide tetraxetan1 intervention
Trial outcomes
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
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 monthsSecondary outcomes
1
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 dose2
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 monthsSponsors and contacts
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Source ClinicalTrials.gov