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

NCT05803941

This study is recruiting at 24 US sites in 20 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Prostate Cancer

Eligibility basics and study details

Study type
Interventional
Phase
Phase 4
Ages
18 to 100 years
Sex
Male
Healthy volunteers
Not accepted
Sponsor
Novartis Pharmaceuticals
Last updated on ClinicalTrials.gov
June 4, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Arizona · 1

  • Mayo Clinic Arizona · Scottsdale, AZ

California · 2

  • St. Joseph Hospital · Orange, CA
  • Providence Saint Johns Health Ctr · Santa Monica, CA

Colorado · 1

  • University of Colorado · Aurora, CO

Connecticut · 1

  • Hartford Hospital · Hartford, CT

District of Columbia · 1

  • VA Medical Center · Washington D.C., DC

Florida · 1

  • Mayo Clinic Jacksonville · Jacksonville, FL

Georgia · 1

  • University Cancer and Blood Center LLC · Athens, GA

Indiana · 1

  • Parkview Research Center · Fort Wayne, IN

Louisiana · 2

  • Ochsner Clinic Foundation · New Orleans, LA
  • Tulane Cancer Center · New Orleans, LA

Michigan · 1

  • Corewell Health William Beaum Hosp · Royal Oak, MI

Minnesota · 1

  • Mayo Clinic Rochester · Rochester, MN

Mississippi · 1

  • University of Mississippi Med Ctr · Jackson, MS

Missouri · 1

  • Wash U School of Medicine · St Louis, MO

Nebraska · 2

  • Nebraska Cancer Specialists · Omaha, NE
  • Urology Cancer Center PC · Omaha, NE

New York · 1

  • Montefiore Medical Center · The Bronx, NY

North Carolina · 1

  • Duke University Medical Center · Durham, NC

Ohio · 1

  • Cleveland Clinic Foundation · Cleveland, OH

Pennsylvania · 1

  • Univ of Pittsburgh Medical Center · Pittsburgh, PA

Texas · 2

  • Univ of Texas Southwest Med Center · Dallas, TX
  • UT Health Science Center · Houston, TX

Virginia · 1

  • Onco Hemato Asso of SW Virginia · Roanoke, VA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.