Metastatic Castration-resistant Prostate Cancer
Conditions
Keywords
Metastatic castration-resistant prostate cancer, mCRPC, PMS, RMP, Pluvicto, Korea
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.
Interventions
OTHERLutetium vipivotide tetraxetan
This is an observational study. There is no treatment allocation. The decision to initiate Lutetium vipivotide tetraxetan will be based solely on clinical judgement.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
South Korea
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed