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

NCT05803941

RecruitingPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Prostate Cancer

Interventions: AAA617

Countries: United States, Austria, Belgium, Canada, Czechia, France, Germany, Netherlands

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.

Eligibility overview

Sex: MALE

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (54)
  • Scottsdale, Arizona, United States
  • Orange, California, United States
  • Santa Monica, California, United States
  • Aurora, Colorado, United States
  • Hartford, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Jacksonville, Florida, United States
  • Athens, Georgia, United States
  • Fort Wayne, Indiana, United States
  • New Orleans, Louisiana, United States
  • New Orleans, Louisiana, United States
  • Royal Oak, Michigan, United States
  • Rochester, Minnesota, United States
  • Jackson, Mississippi, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • Omaha, Nebraska, United States
  • The Bronx, New York, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Roanoke, Virginia, United States
  • Linz, Austria
  • Vienna, Austria
  • Ghent, Belgium
  • Montreal, Quebec, Canada
  • Olomouc, Czechia
  • Prague, Czechia
  • + 24 more on CT.gov