Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
Description
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
Quick Facts
Study Start:2023-08-14
Study Completion:2033-07-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Contacts and Locations
Study Locations (Sites)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
United States
St. Joseph Hospital
Orange, California, 92686
United States
Providence Saint Johns Health Ctr
Santa Monica, California, 90404
United States
University of Colorado
Aurora, Colorado, 80045
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
VA Medical Center
Washington, District of Columbia, 20422
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
University Cancer and Blood Center LLC
Athens, Georgia, 30607
United States
Parkview Research Center
Fort Wayne, Indiana, 46845
United States
Tulane Cancer Center
New Orleans, Louisiana, 70112
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Corewell Health William Beaum Hosp
Royal Oak, Michigan, 48073-6769
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
University of Mississippi Med Ctr
Jackson, Mississippi, 39216
United States
Wash U School of Medicine
Saint Louis, Missouri, 63110
United States
Urology Cancer Center PC
Omaha, Nebraska, 68130
United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68154
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Univ of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Univ of Texas Southwest Med Center
Dallas, Texas, 75390-9034
United States
UT Health Science Center
Houston, Texas, 77030
United States
Onco Hemato Asso of SE Virginia
Roanoke, Virginia, 24014
United States
Collaborators and Investigators
Sponsor: Novartis Pharmaceuticals
- Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2023-08-14
Study Completion Date2033-07-21
Study Record Updates
Study Start Date2023-08-14
Study Completion Date2033-07-21
Terms related to this study
Keywords Provided by Researchers
- Prostate Cancer
- Long-Term Safety Follow-Up
- 177Lu-PSMA-617
- [177Lu]Lu-PSMA-617
- lutetium (177Lu) vipivotide tetraxetan
- AAA617
- parent treatment study
Additional Relevant MeSH Terms