Pluvicto post-marketing safety and effectiveness 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
This program will follow men in Korea with metastatic castration-resistant prostate cancer who are receiving Pluvicto to see if the treatment is safe and works in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 278 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | Novartis Industry-sponsored |
| Locations | 8 sites (Seongnam-si, Gyeonggi-do and 7 other locations) |
| Trial ID | NCT06514521 on ClinicalTrials.gov |
What this trial studies
This is an open-label, multi-center, non-comparative, non-interventional observational program following adult men with mCRPC who are being treated with Pluvicto in South Korea. Patients receive Pluvicto as part of routine clinical care and investigators collect safety and effectiveness data from medical records and scheduled follow-up visits. There is no experimental assignment or additional study drug beyond standard treatment, and the study reflects real-world use across participating Novartis investigative sites. The primary focus is on documenting adverse events, treatment patterns, and clinical outcomes outside of a controlled trial setting.
Who should consider this trial
Good fit: Adult men (age ≥18) in South Korea with metastatic castration-resistant prostate cancer who are scheduled to receive or are receiving Pluvicto and can provide written informed consent are ideal candidates.
Not a fit: Patients without accessible medical records, those unwilling to provide informed consent, or those not receiving Pluvicto are not eligible and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the program could confirm Pluvicto's real-world safety and effectiveness in Korean patients and help clinicians make more informed treatment decisions.
How similar studies have performed: Randomized trials such as VISION demonstrated a survival benefit for Pluvicto in mCRPC, and other real-world observational reports have supported its safety and effectiveness, though post-marketing data specific to Korea remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seongnam-si, Gyeonggi-do and 7 other locations
- Novartis Investigative Site — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
- Novartis Investigative Site — Gyeonggi-do, Korea, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.