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 type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | Men only |
| Enrollment | 278 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Locations | 12 sites (Seongnam-si, Gyeonggi-do and 11 other locations) |
| Status | Recruiting |
| Started | April 18, 2025 |
| Main results expected | May 31, 2028 |
| Study ends | May 31, 2028 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT06514521 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
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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
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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
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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JUR-003 in adults with advanced prostate cancer
This first-in-human study tests JUR-003 to see if it is safe and tolerable and to get an early sense of activity in adults with metastatic or advanced prostate cancer.
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SRT-017 radioligand therapy in PSMA-positive metastatic castration-resistant prostate cancer
This study tests SRT-017 given by IV infusion to men with PSMA-positive metastatic castration-resistant prostate cancer to see if it is safe and tolerable and to gather early signals of anti-tumor activity.
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Rinzimetostat plus darolutamide in metastatic castration-resistant prostate cancer after abiraterone failure
This study tests whether adding rinzimetostat to darolutamide helps people with metastatic castration-resistant prostate cancer who previously took abiraterone.
-
FX-111 safety and pharmacokinetics in metastatic castration-resistant prostate cancer
This study tests whether FX-111 is safe and can help treat metastatic castration-resistant prostate cancer in adult men.
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Docetaxel and SX-682 in head and neck cancers and prostate cancer
This trial tests a new drug SX-682 together with docetaxel in adults whose head and neck cancers or prostate cancer have returned or spread.
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Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer
This trial tests ETB-DualNK-01, a dual-target CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer to see if it is safe and shows early signs of activity.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.