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
- Diseases
- Prostate cancer
- 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
Sites (82)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Not yet recruiting |
| Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Institut Jules Bordet Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Not yet recruiting |
| Fakultni Nemocnice V Motole Coordinator of this site? Confirm its status | Prague 5 | Czechia | Not yet recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Klinikum rechts der Isar der TU Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Rostock University Medical Center Coordinator of this site? Confirm its status | Rostock | Germany | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Institut de Cancerologie de L'Ouest Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Nancy Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Institut public de cancérologie Strauss Europe Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| - Coordinator of this site? Confirm its status | Barnet | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| IRCCS Azienda Ospedaliera Metropolitana Coordinator of this site? Confirm its status | Genoa | Italy | Not yet recruiting |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Reinier de Graaf Groep Coordinator of this site? Confirm its status | Delft | Netherlands | Recruiting |
| Universiteit Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Stichting Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Not yet recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Gliwice | Poland | Not yet recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Not yet recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Sahlgrenska University Hospital-Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| University Cancer And Blood Center LLC Coordinator of this site? Confirm its status | Athens | United States | Recruiting |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Univ of Texas Southwest Med Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Parkview Research Center Coordinator of this site? Confirm its status | Fort Wayne | United States | Recruiting |
| Hartford Hospital Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
| UT Health Science Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Mississippi Med Ctr Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Tulane Cancer Center Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Ochsner Clinic Foundation Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Nebraska Cancer Specialists Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Urology Cancer Center PC Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| St. Joseph Hospital Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Univ of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Onco Hemato Asso of SW Virginia Coordinator of this site? Confirm its status | Roanoke | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Corewell Health William Beaum Hosp Coordinator of this site? Confirm its status | Royal Oak | United States | Recruiting |
| Providence Saint Johns Health Ctr Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
| Mayo Clinic - Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Wash U School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| VA Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.