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NCT05803941RecruitingPhase 4

Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer

A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer

Source: ClinicalTrials.gov · Last updated 4 Jun 2026

Brief summary (registry, in English)

The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other AAA617 causally related serious adverse event(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
700 (estimated)
First submitted
27 Mar 2023
Start date
14 Aug 2023
Primary completion date
20 Jul 2033
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT05803941
EU CT number
2023-503208-94-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 700
  • From 14 Aug 2023 to the primary completion date, 20 Jul 2033
  • 82 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • \- Inability to complete the needed investigational examinations due to any reason.

Who the study is looking for

  • Signed informed consent must be obtained prior to participation in the study
  • Must have received at least one dose of AAA617 within an interventional, Phase I-IV Novartis sponsored clinical trial in prostate cancer and have fulfilled the trial's requirements that allows them to participate in this study.

Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (82)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ordensklinikum Linz GmbH
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LinzAustriaNot yet recruiting
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
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ViennaAustriaNot yet recruiting
Institut Jules Bordet
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BrusselsBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumRecruiting
-
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MontrealCanadaRecruiting
University Hospital Olomouc
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OlomoucCzechiaNot yet recruiting
Fakultni Nemocnice V Motole
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Prague 5CzechiaNot yet recruiting
University Hospital Cologne AöR
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CologneGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Klinikum rechts der Isar der TU Muenchen AöR
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MunichGermanyRecruiting
Rostock University Medical Center
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RostockGermanyRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
Hospital Universitario Regional de Málaga
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MálagaSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
Parc Tauli Hospital Universitari
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SabadellSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Institut de Cancerologie de L'Ouest
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AngersFranceRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceRecruiting
Centre Jean Perrin
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Clermont-FerrandFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
CHRU De Nancy
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Nancy CedexFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Institut public de cancérologie Strauss Europe
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StrasbourgFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
-
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BarnetUnited KingdomRecruiting
-
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CambridgeUnited KingdomRecruiting
-
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GlasgowUnited KingdomRecruiting
-
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MiddlesbroughUnited KingdomRecruiting
-
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SuttonUnited KingdomRecruiting
IRCCS Azienda Ospedaliera Metropolitana
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GenoaItalyNot yet recruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyNot yet recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyNot yet recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyNot yet recruiting
Reinier de Graaf Groep
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DelftNetherlandsRecruiting
Universiteit Maastricht
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MaastrichtNetherlandsRecruiting
Stichting Radboud University Medical Center
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NijmegenNetherlandsRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandNot yet recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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GliwicePolandNot yet recruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandNot yet recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandNot yet recruiting
Sahlgrenska University Hospital-Vastra Gotalandsregionen
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GoteborgSwedenRecruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
University Cancer And Blood Center LLC
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AthensUnited StatesRecruiting
University of Colorado
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AuroraUnited StatesRecruiting
Cleveland Clinic Foundation
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ClevelandUnited StatesRecruiting
Univ of Texas Southwest Med Center
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DallasUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesRecruiting
Parkview Research Center
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Fort WayneUnited StatesRecruiting
Hartford Hospital
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HartfordUnited StatesRecruiting
UT Health Science Center
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HoustonUnited StatesRecruiting
University of Mississippi Med Ctr
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JacksonUnited StatesRecruiting
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesRecruiting
Tulane Cancer Center
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New OrleansUnited StatesRecruiting
Ochsner Clinic Foundation
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New OrleansUnited StatesRecruiting
Nebraska Cancer Specialists
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OmahaUnited StatesRecruiting
Urology Cancer Center PC
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OmahaUnited StatesRecruiting
St. Joseph Hospital
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OrangeUnited StatesRecruiting
Univ of Pittsburgh Medical Center
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PittsburghUnited StatesRecruiting
Onco Hemato Asso of SW Virginia
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RoanokeUnited StatesRecruiting
Mayo Clinic - Rochester
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RochesterUnited StatesRecruiting
Corewell Health William Beaum Hosp
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Royal OakUnited StatesRecruiting
Providence Saint Johns Health Ctr
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Santa MonicaUnited StatesRecruiting
Mayo Clinic - Arizona
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ScottsdaleUnited StatesRecruiting
Wash U School of Medicine
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St LouisUnited StatesRecruiting
Montefiore Medical Center
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The BronxUnited StatesRecruiting
VA Medical Center
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Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.