Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
Recruiting · NCT05803941 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- \- Inability to complete the needed investigational examinations due to any reason.
Where it is running
54 locations listed across 20 US states.
- Mayo Clinic Arizona - Scottsdale, Arizona, United States
- St. Joseph Hospital - Orange, California, United States
- Providence Saint Johns Health Ctr - Santa Monica, California, United States
- University of Colorado - Aurora, Colorado, United States
- Hartford Hospital - Hartford, Connecticut, United States
- VA Medical Center - Washington D.C., District of Columbia, United States
- Mayo Clinic Jacksonville - Jacksonville, Florida, United States
- University Cancer and Blood Center LLC - Athens, Georgia, United States
- Parkview Research Center - Fort Wayne, Indiana, United States
- Tulane Cancer Center - New Orleans, Louisiana, United States
- Ochsner Clinic Foundation - New Orleans, Louisiana, United States
- Corewell Health William Beaum Hosp - Royal Oak, Michigan, United States
- Mayo Clinic Rochester - Rochester, Minnesota, United States
- University of Mississippi Med Ctr - Jackson, Mississippi, United States
- Wash U School of Medicine - St Louis, Missouri, United States
- Urology Cancer Center PC - Omaha, Nebraska, United States
- Nebraska Cancer Specialists - Omaha, Nebraska, United States
- Montefiore Medical Center - The Bronx, New York, United States
- Duke University Medical Center - Durham, North Carolina, United States
- Cleveland Clinic Foundation - Cleveland, Ohio, United States
- Univ of Pittsburgh Medical Center - Pittsburgh, Pennsylvania, United States
- Univ of Texas Southwest Med Center - Dallas, Texas, United States
- UT Health Science Center - Houston, Texas, United States
- Onco Hemato Asso of SW Virginia - Roanoke, Virginia, United States
- Novartis Investigative Site - Barcelona, Spain
- Novartis Investigative Site - Barcelona, Spain
- Novartis Investigative Site - Barnet, United Kingdom
- Novartis Investigative Site - Cambridge, United Kingdom
- Novartis Investigative Site - Essen, Germany
- Novartis Investigative Site - Ghent, Belgium
- Novartis Investigative Site - Glasgow, United Kingdom
- Novartis Investigative Site - Gothenburg, Sweden
- Novartis Investigative Site - Linz, Austria
- Novartis Investigative Site - Lyon, France
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Middlesbrough, United Kingdom
- Novartis Investigative Site - München, Germany
- Novartis Investigative Site - Olomouc, Czechia
- Novartis Investigative Site - Prague, Czechia
- Novartis Investigative Site - Rostock, Germany
- Novartis Investigative Site - Stockholm, Sweden
- Novartis Investigative Site - Valencia, Spain
- Novartis Investigative Site - Vienna, Austria
- Novartis Investigative Site - L'Hospitalet de Llobregat, Barcelona, Spain
- Novartis Investigative Site - Sabadell, Barcelona, Spain
- Novartis Investigative Site - Nijmegen, Gelderland, Netherlands
- Novartis Investigative Site - Maastricht, Limburg, Netherlands
- Novartis Investigative Site - Majadahonda, Madrid, Spain
- Novartis Investigative Site - Montreal, Quebec, Canada
- Novartis Investigative Site - Delft, South Holland, Netherlands
- Novartis Investigative Site - Sutton, Surrey, United Kingdom