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 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. 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:
* 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.
Exclusion Criteria:
- Inability to complete the needed investigational examinations due to any reason.
Novartis Investigative Site
Recruiting
Linz,4020,Austria
Novartis Investigative Site
Recruiting
Wien,1090,Austria
Novartis Investigative Site
Recruiting
Gent,9000,Belgium
Novartis Investigative Site
Recruiting
Montreal,Quebec,H2x 1r9,Canada
Novartis Investigative Site
Recruiting
Praha 5,150 06,Czechia
Novartis Investigative Site
Recruiting
Olomouc,779 00,Czechia
Novartis Investigative Site
Recruiting
Lyon,69373,France
Novartis Investigative Site
Recruiting
Essen,45147,Germany
Novartis Investigative Site
Recruiting
Muenchen,80377,Germany
Novartis Investigative Site
Recruiting
Rostock,18057,Germany
Novartis Investigative Site
Recruiting
Nijmegen,6500hb,Netherlands
Novartis Investigative Site
Recruiting
Delft,2625 ad,Netherlands
Novartis Investigative Site
Recruiting
Maastricht,6229 hx,Netherlands
Novartis Investigative Site
Recruiting
Madrid,28040,Spain
Novartis Investigative Site
Recruiting
Madrid,28041,Spain
Novartis Investigative Site
Recruiting
Sabadell,Barcelona,08208,Spain
Novartis Investigative Site
Recruiting
Madrid,28046,Spain
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08035,Spain
Novartis Investigative Site
Recruiting
Madrid,28222,Spain
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08036,Spain
Novartis Investigative Site
Recruiting
Valencia,46026,Spain
Novartis Investigative Site
Recruiting
Hospitalet de LLobregat,Catalunya,08907,Spain
Novartis Investigative Site
Recruiting
Madrid,28034,Spain
Novartis Investigative Site
Recruiting
Goteborg,413 45,Sweden
Novartis Investigative Site
Recruiting
Stockholm,17176,Sweden
Novartis Investigative Site
Recruiting
Sutton,Surrey,Sm2 5pt,United Kingdom
Novartis Investigative Site
Recruiting
Barnet,En5 3dj,United Kingdom
Novartis Investigative Site
Recruiting
Cambridge,Cb2 0qq,United Kingdom
Novartis Investigative Site
Recruiting
Glasgow,G12 0yn,United Kingdom
Novartis Investigative Site
Recruiting
Middlesbrough,Ts4 3bw,United Kingdom
Univ of Texas Southwest Med Center
Recruiting
Dallas,Texas,75390-9034,United States
Kevin Courtney
Parkview Research Center
Recruiting
Fort Wayne,Indiana,46845,United States
Brian Chang
Providence Saint Johns Health Ctr
Recruiting
Santa Monica,California,90404,United States
Przemyslaw Twardowski
Onco Hemato Asso of SE Virginia
Recruiting
Roanoke,Virginia,24014,United States
David Buck
University of Mississippi Med Ctr
Recruiting
Jackson,Mississippi,39216,United States
John Clark Henegan
Corewell Health William Beaum Hosp
Recruiting
Royal Oak,Michigan,48073-6769,United States
Andrew Thompson
UT Health Science Center
Recruiting
Houston,Texas,77030,United States
Bo Chen
VA Medical Center
Recruiting
Washington,District of Columbia,20422,United States
Frank Liu
University of Colorado
Recruiting
Aurora,Colorado,80045,United States
Muthiah Nachiappan
Mayo Clinic Rochester
Recruiting
Rochester,Minnesota,55905,United States
Brian Costello
Hartford Hospital
Recruiting
Hartford,Connecticut,06102,United States
Andrew Salner
Nebraska Cancer Specialists
Recruiting
Omaha,Nebraska,68154,United States
Ralph Hauke
Wash U School of Medicine
Recruiting
Saint Louis,Missouri,63110,United States
Hyun Kim
Lindsey Mayer
Mayo Clinic Jacksonville
Recruiting
Jacksonville,Florida,32224,United States
Winston Tan
Montefiore Medical Center
Recruiting
Bronx,New York,10467,United States
Benjamin A Gartrell
University Cancer and Blood Center LLC
Recruiting
Athens,Georgia,30607,United States
Petros Nikolinakos
Duke University Medical Center
Recruiting
Durham,North Carolina,27710,United States
Daniel J. George
Ochsner Clinic Foundation
Recruiting
New Orleans,Louisiana,70121,United States
Stephen Bardot
Univ of Pittsburgh Medical Center
Recruiting
Pittsburgh,Pennsylvania,15232,United States
Leonard Appleman
St. Joseph Hospital
Recruiting
Orange,California,92686,United States
Timothy Byun
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.