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Clinical trialNCT05939414RecruitingPhase 3Interventional

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

SponsorNovartis PharmaceuticalsEnrollment450Oligometastatic Prostate Cancer (OMPC)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

144 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina
  • Novartis Investigative Site

    CABA, Buenos Aires, Argentina

    Recruiting
  • Novartis Investigative Site

    CABA, Argentina

    Recruiting
  • Novartis Investigative Site

    Caba, Argentina

    Recruiting
Australia
  • Novartis Investigative Site

    Darlinghurst, New South Wales, Australia

    Recruiting
  • Novartis Investigative Site

    Herston, Queensland, Australia

    Recruiting
  • Novartis Investigative Site

    Adelaide, South Australia, Australia

    Recruiting
  • Novartis Investigative Site

    Malvern, Victoria, Australia

    Recruiting
Austria
  • Novartis Investigative Site

    Linz, Austria

    Recruiting
  • Novartis Investigative Site

    Vienna, Austria

    Recruiting
Belgium
  • Novartis Investigative Site

    Aalst, Belgium

    Recruiting
  • Novartis Investigative Site

    Ghent, Belgium

    Recruiting
  • Novartis Investigative Site

    Wilrijk, Belgium

    Recruiting
Brazil
  • Novartis Investigative Site

    São Paulo, São Paulo, Brazil

    Recruiting
Canada
  • Novartis Investigative Site

    Calgary, Alberta, Canada

    Recruiting
  • Novartis Investigative Site

    Halifax, Nova Scotia, Canada

    Recruiting
  • Novartis Investigative Site

    London, Ontario, Canada

    Recruiting
  • Novartis Investigative Site

    Ottawa, Ontario, Canada

    Recruiting
  • Novartis Investigative Site

    Toronto, Ontario, Canada

    Recruiting
  • Novartis Investigative Site

    Montreal, Quebec, Canada

    Recruiting
  • Novartis Investigative Site

    Montreal, Quebec, Canada

    Recruiting
  • Novartis Investigative Site

    Québec, Quebec, Canada

    Recruiting
China
  • Novartis Investigative Site

    Beijing, China

    Recruiting
  • Novartis Investigative Site

    Guangzhou, China

    Recruiting
  • Novartis Investigative Site

    Shanghai, China

    Recruiting
Colombia
  • Novartis Investigative Site

    Bogota, Cundinamarca, Colombia

    Recruiting
  • Novartis Investigative Site

    Bogotá, Colombia

    Recruiting
Czechia
  • Novartis Investigative Site

    Ostrava, Poruba, Czechia

    Recruiting
  • Novartis Investigative Site

    Olomouc, Czechia

    Recruiting
  • Novartis Investigative Site

    Prague, Czechia

    Recruiting
France
  • Novartis Investigative Site

    Saint-Cloud, Hauts De Seine, France

    Recruiting
  • Novartis Investigative Site

    Bordeaux, France

    Recruiting
  • Novartis Investigative Site

    Bron, France

    Recruiting
  • Novartis Investigative Site

    Clermont-Ferrand, France

    Recruiting
  • Novartis Investigative Site

    Rouen, France

    Recruiting
  • Novartis Investigative Site

    Saint-Herblain, France

    Recruiting
Germany
  • Novartis Investigative Site

    Munich, Bavaria, Germany

    Recruiting
  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, Germany

    Recruiting
  • Novartis Investigative Site

    Aachen, Germany

    Recruiting
  • Novartis Investigative Site

    Augsburg, Germany

    Recruiting
  • Novartis Investigative Site

    Berlin, Germany

    Recruiting
104 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Vipivotide tetraxetan →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
12 Mar 2024
Primary completion
25 Apr 2028
Completion
3 Oct 2031
Last update posted
3 Aug 2026
Registered enrollment
450
Registry id
NCT05939414

Cross-registrations

EU-CTR / CTIS (EudraCT)2022-502956-29-00
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.