Study 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 serious adverse reaction(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. This is a global, prospective, multi-center, long-term follow-up (LTFU) safety study of
adult participants with prostate cancer that have received at least one dose of AAA617
from interventional, Phase I-IV Novartis sponsored clinical trials.
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.
Interventions
AAA617
Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent must be obtained prior to participation in the study
2. 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.
3. Willingness of sexually active participant to use a condom during intercourse for up
to 14 weeks from the last dose of AAA617 treatment administered on the parent study.
Exclusion Criteria:
1. Inability to complete the needed investigational examinations due to any reason.
Novartis Investigative Site
Recruiting
Linz,4020,Austria
Novartis Investigative Site
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Wien,1090,Austria
Novartis Investigative Site
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Gent,9000,Belgium
Novartis Investigative Site
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Montreal,Quebec,H2x 1r9,Canada
Novartis Investigative Site
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Olomouc,CZE,779 00,Czechia
Novartis Investigative Site
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Praha 5,150 06,Czechia
Novartis Investigative Site
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Lyon,69373,France
Novartis Investigative Site
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Rostock,18057,Germany
Novartis Investigative Site
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Essen,45147,Germany
Novartis Investigative Site
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Muenchen,80377,Germany
Novartis Investigative Site
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Delft,2625 ad,Netherlands
Novartis Investigative Site
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Maastricht,6229 hx,Netherlands
Novartis Investigative Site
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Nijmegen,6500hb,Netherlands
Novartis Investigative Site
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Barcelona,Catalunya,08036,Spain
Novartis Investigative Site
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Valencia,46026,Spain
Novartis Investigative Site
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Hospitalet de LLobregat,Catalunya,08907,Spain
Novartis Investigative Site
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Madrid,28034,Spain
Novartis Investigative Site
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Madrid,28040,Spain
Novartis Investigative Site
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Madrid,28041,Spain
Novartis Investigative Site
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Sabadell,Barcelona,08208,Spain
Novartis Investigative Site
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Madrid,28046,Spain
Novartis Investigative Site
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Barcelona,Catalunya,08035,Spain
Novartis Investigative Site
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Madrid,28222,Spain
Novartis Investigative Site
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Goteborg,413 45,Sweden
Novartis Investigative Site
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Stockholm,17176,Sweden
Novartis Investigative Site
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Cambridge,Cb2 0qq,United Kingdom
Novartis Investigative Site
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Glasgow,G12 0yn,United Kingdom
Novartis Investigative Site
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Middlesbrough,Ts4 3bw,United Kingdom
Novartis Investigative Site
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Sutton,Surrey,Sm2 5pt,United Kingdom
Novartis Investigative Site
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Barnet,En5 3dj,United Kingdom
University of Colorado .
Recruiting
Aurora,Colorado,80045,United States
Muthiah Nachiappan
Mayo Clinic Rochester .
Recruiting
Rochester,Minnesota,55905,United States
Brian Costello
Univ of Texas Southwest Med Center Department of Urology
Recruiting
Dallas,Texas,75390-9034,United States
Kevin Courtney
Parkview Research Center .
Recruiting
Fort Wayne,Indiana,46845,United States
Brian Chang
Nebraska Cancer Specialists .
Recruiting
Omaha,Nebraska,68154,United States
Ralph Hauke
Hartford Hospital .
Recruiting
Hartford,Connecticut,06102,United States
Andrew Salner
University of Mississippi Med Ctr
Recruiting
Jackson,Mississippi,39216,United States
John Clark Henegan
UT Health Science Center .
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Houston,Texas,77030,United States
Bo Chen
Montefiore Medical Center .
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Bronx,New York,10467,United States
Benjamin A Gartrell
VA Medical Center
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Washington,District of Columbia,20422,United States
Frank Liu
Onco Hemato Asso of SE Virginia
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Roanoke,Virginia,24014,United States
David Buck
Duke University Medical Center .
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Durham,North Carolina,27710,United States
Daniel J. George
Wash U School of Medicine .
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Saint Louis,Missouri,63110,United States
Hyun Kim
Lindsey Mayer
Ochsner Clinic Foundation
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New Orleans,Louisiana,70121,United States
Stephen Bardot
Mayo Clinic Jacksonville .
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Jacksonville,Florida,32224,United States
Winston Tan
St. Joseph Hospital .
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Orange,California,92686,United States
Timothy Byun
University Cancer and Blood Center, LLC
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Athens,Georgia,30607,United States
Petros Nikolinakos
Providence Saint Johns Health Ctr .
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Santa Monica,California,90404,United States
Przemyslaw Twardowski
Pharmacy Beaumont Hospital .
Recruiting
Royal Oak,Michigan,48073-6769,United States
Andrew Thompson
Univ of Pittsburgh Medical Center .
Recruiting
Pittsburgh,Pennsylvania,15232,United States
Leonard Appleman
Worldwide Contacts
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