Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
NCT ID: NCT05803941
Last Updated: 2025-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
700 participants
INTERVENTIONAL
2023-08-14
2033-07-21
Brief Summary
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Detailed Description
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There will be no study treatment administered to participants in this study. Participants will have visits every 6-8 months for monitoring of selected AEs and laboratory parameters. The study periods include a Baseline and Follow-up Period (up to 10 years after first dose of AAA617 in parent treatment study).
Participants should enroll into the LTFU study after parent treatment study requirements are fulfilled (refer to the parent treatment study protocol for requirements, including any additional requirements after participant enters this LTFU safety study).
The schedule of activities for this LTFU study is designed to start from date of informed consent for this LTFU study. Participants should be followed every 6 to 8 months for up to a total of 10 years starting from first dose of AAA617 in the parent treatment study. Participants entering the LTFU study will have already completed a variable portion of the required 10-year follow-up within the parent treatment study. The specific number of visits required in this LTFU study will depend upon the time of enrollment into this LTFU study following the first dose of AAA617 in the parent treatment study.
The total number of participants to be enrolled and the duration of this LTFU study will depend upon the total number treated in the parent treatment studies and their duration.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
100 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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2023-503208-94-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CAAA617A12402
Identifier Type: -
Identifier Source: org_study_id
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