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RECRUITING
NCT05803941
PHASE4

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

MALE

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2023-08-14

Completion Date

2033-07-21

Last Updated

2025-04-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

AAA617

Long-term follow-up (LTFU) safety study of adult participants with prostate cancer that have received at least one dose of AAA617 from parent interventional Novartis sponsored clinical trials.

Locations (54)

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 SE Virginia

Roanoke, Virginia, United States

Novartis Investigative Site

Linz, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Ghent, Belgium

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Olomouc, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Lyon, France

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

München, Germany

Novartis Investigative Site

Rostock, Germany

Novartis Investigative Site

Delft, Netherlands

Novartis Investigative Site

Maastricht, Netherlands

Novartis Investigative Site

Nijmegen, Netherlands

Novartis Investigative Site

Sabadell, Barcelona, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Valencia, Spain

Novartis Investigative Site

Gothenburg, Sweden

Novartis Investigative Site

Stockholm, Sweden

Novartis Investigative Site

Sutton, Surrey, United Kingdom

Novartis Investigative Site

Barnet, United Kingdom

Novartis Investigative Site

Cambridge, United Kingdom

Novartis Investigative Site

Glasgow, United Kingdom

Novartis Investigative Site

Middlesbrough, United Kingdom