Clinical trial · Observational
Post Marketing Study on Pluvicto in Korea
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
NCT06514521CI-TRIAL-00116919recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Post marketing study on Pluvicto in Korea
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lutetium vipivotide tetraxetan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Lutetium vipivotide tetraxetan
- description
- Patients prescribed with Lutetium vipivotide tetraxetan in real world practice
- interventionNames
- Other: Lutetium vipivotide tetraxetan
Primary outcomes (1)
- measure
- Incidence of Adverse Events, Serious Adverse Events, unexpected Adverse Events, Adverse Drug Reactions, Serious Adverse Drug Reactions and unexpected Adverse Drug Reactions
- timeFrame
- Until 30 days after the last dose of Pluvicto, up to 33 months
- description
- 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.
Secondary outcomes (2)
- measure
- Objective response rate (ORR) as assessed by investigator
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.