Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
Recruiting now · Phase 4
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT05803941
- Run by
- Novartis Pharmaceuticals
- People needed
- 700
- Starts
- 2023-08-14
- Expected to finish
- 2033-07-21
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Inability to complete the needed investigational examinations due to any reason.
Where it is running
- St. Joseph Hospital — Orange, California, United States (enrolling)
- Providence Saint Johns Health Ctr — Santa Monica, California, United States (enrolling)
- University of Colorado — Aurora, Colorado, United States (enrolling)
- Hartford Hospital — Hartford, Connecticut, United States (enrolling)
- VA Medical Center — Washington D.C., District of Columbia, United States (enrolling)
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
- University Cancer and Blood Center LLC — Athens, Georgia, United States (enrolling)
- Parkview Research Center — Fort Wayne, Indiana, United States (enrolling)
- Tulane Cancer Center — New Orleans, Louisiana, United States (enrolling)
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States (enrolling)
- Corewell Health William Beaum Hosp — Royal Oak, Michigan, United States (enrolling)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
- University of Mississippi Med Ctr — Jackson, Mississippi, United States (enrolling)
- Wash U School of Medicine — St Louis, Missouri, United States (enrolling)
- Urology Cancer Center PC — Omaha, Nebraska, United States (enrolling)
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
- Montefiore Medical Center — The Bronx, New York, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
- Univ of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
- Univ of Texas Southwest Med Center — Dallas, Texas, United States (enrolling)
- UT Health Science Center — Houston, Texas, United States (enrolling)
- Onco Hemato Asso of SW Virginia — Roanoke, Virginia, United States (enrolling)
- Novartis Investigative Site — Linz, Austria (enrolling)
- Mayo Clinic Arizona — Scottsdale, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.