Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lutetium vipivotide tetraxetan | Patients prescribed with Lutetium vipivotide tetraxetan in real world practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutetium vipivotide tetraxetan | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Until 30 days after the last dose of Pluvicto, up to 33 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion criteria
Study participants eligible for inclusion in this study must meet all of the following criteria:
Exclusion criteria
Study participants meeting any of the following criteria are not eligible for inclusion in this study:
Not provided
Not provided
Patients who have been using or going to receive Pluvicto per clinical judgment under routine medical practice are eligible for the study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000610110 | Pluvicto |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | Up to 33 months |
| Novartis Investigative Site |
| Recruiting |
| Suwon |
| Gyeonggi-do |
| 442-723 |
| South Korea |
| Novartis Investigative Site | Recruiting | Busan | Korea | 46033 | South Korea |
| Novartis Investigative Site | Recruiting | Gyeonggi-do | Korea | 10408 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Seoul | 03374 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Recruiting | Jeollanam | 519763 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 01812 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 06591 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 110-744 | South Korea |