A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Mayo Clinic Arizona
RECRUITING
Scottsdale
California
St. Joseph Hospital
RECRUITING
Orange
Providence Saint Johns Health Ctr
RECRUITING
Santa Monica
Colorado
University of Colorado
RECRUITING
Aurora
Connecticut
Hartford Hospital
RECRUITING
Hartford
Washington, D.c.
VA Medical Center
RECRUITING
Washington D.c.
Florida
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Georgia
University Cancer and Blood Center LLC
RECRUITING
Athens
Indiana
Parkview Research Center
RECRUITING
Fort Wayne
Louisiana
Ochsner Clinic Foundation
RECRUITING
New Orleans
Tulane Cancer Center
RECRUITING
New Orleans
Michigan
Corewell Health William Beaum Hosp
RECRUITING
Royal Oak
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
Wash U School of Medicine
RECRUITING
St Louis
Mississippi
University of Mississippi Med Ctr
RECRUITING
Jackson
North Carolina
Duke University Medical Center
RECRUITING
Durham
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
Urology Cancer Center PC
RECRUITING
Omaha
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Pennsylvania
Univ of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Texas
Univ of Texas Southwest Med Center
RECRUITING
Dallas
UT Health Science Center
RECRUITING
Houston
Virginia
Onco Hemato Asso of SE Virginia
RECRUITING
Roanoke
Other Locations
Austria
Novartis Investigative Site
RECRUITING
Linz
Novartis Investigative Site
RECRUITING
Vienna
Belgium
Novartis Investigative Site
RECRUITING
Ghent
Canada
Novartis Investigative Site
RECRUITING
Montreal
France
Novartis Investigative Site
RECRUITING
Lyon
Germany
Novartis Investigative Site
RECRUITING
Essen
Novartis Investigative Site
RECRUITING
München
Novartis Investigative Site
RECRUITING
Rostock
Netherlands
Novartis Investigative Site
RECRUITING
Delft
Novartis Investigative Site
RECRUITING
Maastricht
Novartis Investigative Site
RECRUITING
Nijmegen
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
L'hospitalet De Llobregat
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Sabadell
Novartis Investigative Site
RECRUITING
Valencia
Sweden
Novartis Investigative Site
RECRUITING
Gothenburg
Novartis Investigative Site
RECRUITING
Stockholm
United Kingdom
Novartis Investigative Site
RECRUITING
Barnet
Novartis Investigative Site
RECRUITING
Cambridge
Novartis Investigative Site
RECRUITING
Glasgow
Novartis Investigative Site
RECRUITING
Middlesbrough
Novartis Investigative Site
RECRUITING
Sutton
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date: 2023-08-14
Estimated Completion Date: 2033-07-21
Participants
Target number of participants: 700
Treatments
Other: Single arm
Participants will be followed until death, lost to follow-up, or up to 10 years from first dose of AAA617, whichever occurs first.~There will be no study treatment administered to participants while participating in this study.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals