Post Marketing Study on Pluvicto in Korea
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Other: Lutetium vipivotide tetraxetan
- Registration Number
- NCT06514521
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 278
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lutetium vipivotide tetraxetan Lutetium vipivotide tetraxetan Patients prescribed with Lutetium vipivotide tetraxetan in real world practice
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events, Serious Adverse Events, unexpected Adverse Events, Adverse Drug Reactions, Serious Adverse Drug Reactions and unexpected Adverse Drug Reactions Until 30 days after the last dose of Pluvicto, up to 33 months 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 Outcome Measures
Name Time Method Radiographic progression-free survival (rPFS) Up to 33 months 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.
Objective response rate (ORR) as assessed by investigator 4th±1 week from the last dose 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.