Metastatic Castration-resistant Prostate CancerNCT06514521
Post Marketing Study on Pluvicto in Korea
An observational study of Metastatic Castration-resistant Prostate Cancer, run by Novartis Pharmaceuticals at 12 sites in South Korea.
Trial summary
Post marketing study on Pluvicto in Korea Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Lutetium vipivotide tetraxetan
- How many people
- 278 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 18 Apr 2025to 31 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been using or going to receive Pluvicto per clinical judgment under routine medical practice are eligible for the study
Who may be able to join
- Study participants eligible for inclusion in this study must meet all of the following criteria:
- Male adult patient age ≥ 18
- 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
- Subject who provided the written informed consent prior to the study enrollment
Who cannot join
- Study participants meeting any of the following criteria are not eligible for inclusion in this study:
- Subject whose medical record is not accessible
- Subject who is not willing to provide the informed consent
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
12 sites in 1 country
South Korea12 sites, 12 recruiting
- Recruiting
Novartis Investigative Site
Busan, Korea, 46033
- Recruiting
Novartis Investigative Site
Gyeonggi-do, Korea, 10408
- Recruiting
Novartis Investigative Site
Jeollanam, 519763
- Recruiting
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Novartis Investigative Site
Seoul, Seoul, 03374
- Recruiting
Novartis Investigative Site
Seoul, Seoul, 06351
- Recruiting
Novartis Investigative Site
Seoul, 01812
- Recruiting
Novartis Investigative Site
Seoul, 03722
- Recruiting
Novartis Investigative Site
Seoul, 05505
- Recruiting
Novartis Investigative Site
Seoul, 06591
- Recruiting
Novartis Investigative Site
Seoul, 110-744
- Recruiting
Novartis Investigative Site
Suwon, Gyeonggi-do, 442-723
About this study
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
Post marketing study on Pluvicto in Korea
Read the 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.
- Being tested
- Lutetium vipivotide tetraxetan
- Keywords
- Metastatic castration-resistant prostate cancer, mCRPC, PMS, RMP, Pluvicto, Korea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetium vipivotide tetraxetanOther
Also called Pluvicto
This is an observational study. There is no treatment allocation. The decision to initiate Lutetium vipivotide tetraxetan will be based solely on clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| Lutetium vipivotide tetraxetan | Patients prescribed with Lutetium vipivotide tetraxetan in real world practice Receives: Other: Lutetium vipivotide tetraxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until 30 days after the last dose of Pluvicto, up to 33 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start18 Apr 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514521
- Sponsor's protocol ID
- CAAA617A1KR01
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06514521
- Acronym / sponsor ID
- CAAA617A1KR01
- Keywords
- Metastatic castration-resistant prostate cancer, mCRPC, PMS, RMP, Pluvicto, Korea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lutetium vipivotide tetraxetan | – | Other: Lutetium vipivotide tetraxetanPatients prescribed with Lutetium vipivotide tetraxetan in real world practice |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been using or going to receive Pluvicto per clinical judgment under routine medical practice are eligible for the study
Key inclusion criteria (4 listed)
- Study participants eligible for inclusion in this study must meet all of the following criteria:
- Male adult patient age ≥ 18
- 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
- Subject who provided the written informed consent prior to the study enrollment
Key exclusion criteria (3 listed)
- Study participants meeting any of the following criteria are not eligible for inclusion in this study:
- Subject whose medical record is not accessible
- Subject who is not willing to provide the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutetium vipivotide tetraxetanAlso: PluvictoThis is an observational study. There is no treatment allocation. The decision to initiate Lutetium vipivotide tetraxetan will be based solely on clinical judgement. | Other | Lutetium vipivotide tetraxetan |
Primary outcome
Incidence of Adverse Events, Serious Adverse Events, unexpected Adverse Events, Adverse Drug Reactions, Serious Adverse Drug Reactions and unexpected Adverse Drug Reactions
Time frame: 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.
2 secondary outcomes
Objective response rate (ORR) as assessed by investigator
Time frame: 4th±1 week from the last dose
Radiographic progression-free survival (rPFS)
Time frame: Up to 33 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castration-resistant Prostate Cancer
RecruitingPhase 1/2
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Metastatic Prostate Cancer
RecruitingPhase 3
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Castration-Resistant
RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
Active, not recruitingPhase 1
A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms
Active, not recruitingPhase 3
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
Castration-Resistant Prostatic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration-resistant Prostate Cancer, run by Novartis Pharmaceuticals at 12 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Serious Adverse Events, unexpected Adverse Events, Adverse Drug Reactions, Serious Adverse Drug Reactions and unexpected Adverse Drug Reactions (time frame: Until 30 days after the last dose of Pluvicto, up to 33 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.