Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer
2 other identifiers
interventional
700
11 countries
54
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 prostate-cancer
Started Aug 2023
Longer than P75 for phase_4 prostate-cancer
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2023
CompletedFirst Posted
Study publicly available on registry
April 7, 2023
CompletedStudy Start
First participant enrolled
August 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 21, 2033
April 24, 2025
April 1, 2025
9.9 years
March 27, 2023
April 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and percentage of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs)
Selected adverse events (AEs) include xerostomia, xerophtalmia, myelosupression, renal toxicity and second primary malignancy and their complication. Only SAEs considered causally related to previous treatment with AAA617 will be considered.
every visit up to 10 years after 1st dose of AAA617 received in parent treatment study
Secondary Outcomes (2)
Number and percentage of participants who have died
every visit up to 10 years after 1st dose of AAA617 received in parent treatment study
Absorbed radiation dose in kidney or other selected organs and number of AEs
every visit up to 10 years after 1st dose of AAA617 received in parent treatment study
Study Arms (1)
Single arm
OTHERParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- Inability to complete the needed investigational examinations due to any reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
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 D.C., 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
St 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
The 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
Novartis Investigative Site
Linz, 4020, Austria
Novartis Investigative Site
Vienna, 1090, Austria
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Montreal, Quebec, H2X 1R9, Canada
Novartis Investigative Site
Olomouc, 779 00, Czechia
Novartis Investigative Site
Prague, 150 06, Czechia
Novartis Investigative Site
Lyon, 69373, France
Novartis Investigative Site
Essen, 45147, Germany
Novartis Investigative Site
München, 80377, Germany
Novartis Investigative Site
Rostock, 18057, Germany
Novartis Investigative Site
Delft, 2625 AD, Netherlands
Novartis Investigative Site
Maastricht, 6229 HX, Netherlands
Novartis Investigative Site
Nijmegen, 6500HB, Netherlands
Novartis Investigative Site
Sabadell, Barcelona, 08208, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08036, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907, Spain
Novartis Investigative Site
Madrid, 28034, Spain
Novartis Investigative Site
Madrid, 28040, Spain
Novartis Investigative Site
Madrid, 28041, Spain
Novartis Investigative Site
Madrid, 28046, Spain
Novartis Investigative Site
Madrid, 28222, Spain
Novartis Investigative Site
Valencia, 46026, Spain
Novartis Investigative Site
Gothenburg, 413 45, Sweden
Novartis Investigative Site
Stockholm, 17176, Sweden
Novartis Investigative Site
Sutton, Surrey, SM2 5PT, United Kingdom
Novartis Investigative Site
Barnet, EN5 3DJ, United Kingdom
Novartis Investigative Site
Cambridge, CB2 0QQ, United Kingdom
Novartis Investigative Site
Glasgow, G12 0YN, United Kingdom
Novartis Investigative Site
Middlesbrough, TS4 3BW, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2023
First Posted
April 7, 2023
Study Start
August 14, 2023
Primary Completion (Estimated)
July 20, 2033
Study Completion (Estimated)
July 21, 2033
Last Updated
April 24, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.