Clinical trial Recruiting at 12 sites Observational Ages 18 to 100 Men only

Pluvicto post-marketing safety and effectiveness in Korea.

Official title: 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

Run by Novartis · NCT06514521 · Data updated 2026-11-12

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 typeObservational
Ages18 Years to 100 Years
SexMen only
Enrollment278 (estimated)
SponsorNovartis
Industry-sponsored
Locations12 sites (Seongnam-si, Gyeonggi-do and 11 other locations)
StatusRecruiting
StartedApril 18, 2025
Main results expectedMay 31, 2028
Study endsMay 31, 2028
Registry record updatedJuly 6, 2026
Trial IDNCT06514521 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Novartis Investigative Site
    Seongnam-si, Gyeonggi-do, South Korea
    Recruiting
  • Novartis Investigative Site
    Suwon, Gyeonggi-do, South Korea
    Recruiting
  • Novartis Investigative Site
    Busan, Korea, South Korea
    Recruiting
  • Novartis Investigative Site
    Gyeonggi-do, Korea, South Korea
    Recruiting
  • Novartis Investigative Site
    Seoul, Seoul, South Korea
    Recruiting
  • Novartis Investigative Site
    Seoul, Seoul, South Korea
    Recruiting
Show 6 more locations
  • Novartis Investigative Site
    Jeollanam, 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.