Trial Title:
Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
NCT ID:
NCT05803941
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Pluvicto
Conditions: Keywords:
Prostate Cancer
Long-Term Safety Follow-Up
177Lu-PSMA-617
[177Lu]Lu-PSMA-617
lutetium (177Lu) vipivotide tetraxetan
AAA617
parent treatment study
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AAA617
Description:
Long-term follow-up (LTFU) safety study of adult participants with prostate cancer that
have received at least one dose of AAA617 from parent clinical interventional Novartis
sponsored clinical trials.
Arm group label:
Single arm
Other name:
lutetium (177Lu) vipivotide tetraxetan
Other name:
[177Lu]Lu-PSMA-617
Other name:
177Lu-PSMA-617
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 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.
Detailed description:
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.
Criteria for 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.
Gender:
Male
Gender based:
Yes
Gender description:
Prostate cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Phone:
480-301-8300
Investigator:
Last name:
Cassandra Moore
Email:
Principal Investigator
Facility:
Name:
St. Joseph Hospital .
Address:
City:
Orange
Zip:
92686
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Timothy Byun
Email:
Principal Investigator
Facility:
Name:
Providence Saint Johns Health Ctr .
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Przemyslaw Twardowski
Email:
Principal Investigator
Facility:
Name:
University of Colorado .
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Muthiah Nachiappan
Email:
Principal Investigator
Facility:
Name:
Hartford Hospital .
Address:
City:
Hartford
Zip:
06102
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Andrew Salner
Email:
Principal Investigator
Facility:
Name:
VA Medical Center
Address:
City:
Washington
Zip:
20422
Country:
United States
Status:
Recruiting
Contact:
Phone:
202-745-8457
Investigator:
Last name:
Frank Liu
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Jacksonville .
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Winston Tan
Email:
Principal Investigator
Facility:
Name:
University Cancer and Blood Center, LLC
Address:
City:
Athens
Zip:
30607
Country:
United States
Status:
Recruiting
Contact:
Phone:
706-353-2990
Investigator:
Last name:
Petros Nikolinakos
Email:
Principal Investigator
Facility:
Name:
Parkview Research Center .
Address:
City:
Fort Wayne
Zip:
46845
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Brian Chang
Email:
Principal Investigator
Facility:
Name:
Tulane Cancer Center
Address:
City:
New Orleans
Zip:
70112
Country:
United States
Status:
Recruiting
Contact:
Phone:
504-585-6077
Investigator:
Last name:
Brian Lewis
Email:
Principal Investigator
Facility:
Name:
Ochsner Clinic Foundation
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Contact:
Phone:
504-842-6044
Investigator:
Last name:
Stephen Bardot
Email:
Principal Investigator
Facility:
Name:
Pharmacy Beaumont Hospital .
Address:
City:
Royal Oak
Zip:
48073-6769
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Andrew Thompson
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Rochester .
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Brian Costello
Email:
Principal Investigator
Facility:
Name:
University of Mississippi Med Ctr
Address:
City:
Jackson
Zip:
39216
Country:
United States
Status:
Recruiting
Contact:
Phone:
+1 601 815 5374
Investigator:
Last name:
John Clark Henegan
Email:
Principal Investigator
Facility:
Name:
Wash U School of Medicine .
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lindsey Mayer
Email:
lindseymayer@wustl.edu
Investigator:
Last name:
Hyun Kim
Email:
Principal Investigator
Facility:
Name:
Urology Cancer Center PC
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Contact:
Phone:
402-697-2229
Investigator:
Last name:
Luke Nordquist
Email:
Principal Investigator
Facility:
Name:
Nebraska Cancer Specialists .
Address:
City:
Omaha
Zip:
68154
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ralph Hauke
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center .
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Benjamin A Gartrell
Email:
Principal Investigator
Facility:
Name:
Duke University Medical Center .
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Daniel J. George
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Phone:
216-444-0441
Investigator:
Last name:
Shilpa Gupta
Email:
Principal Investigator
Facility:
Name:
Univ of Pittsburgh Medical Center .
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Leonard Appleman
Email:
Principal Investigator
Facility:
Name:
Univ of Texas Southwest Med Center Department of Urology
Address:
City:
Dallas
Zip:
75390-9034
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Kevin Courtney
Email:
Principal Investigator
Facility:
Name:
UT Health Science Center .
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Bo Chen
Email:
Principal Investigator
Facility:
Name:
Onco Hemato Asso of SE Virginia
Address:
City:
Roanoke
Zip:
24014
Country:
United States
Status:
Recruiting
Contact:
Phone:
540-774-8660
Investigator:
Last name:
David Buck
Email:
Principal Investigator
Facility:
Name:
Novartis Investigative Site
Address:
City:
Linz
Zip:
4020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Wien
Zip:
1090
Country:
Austria
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Montreal
Zip:
H2X 1R9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Olomouc
Zip:
779 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Praha 5
Zip:
150 06
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Muenchen
Zip:
80377
Country:
Germany
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Rostock
Zip:
18057
Country:
Germany
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Delft
Zip:
2625 AD
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Nijmegen
Zip:
6500HB
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Sabadell
Zip:
08208
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Hospitalet de LLobregat
Zip:
08907
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Madrid
Zip:
28222
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Goteborg
Zip:
413 45
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Stockholm
Zip:
17176
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Barnet
Zip:
EN5 3DJ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Middlesbrough
Zip:
TS4 3BW
Country:
United Kingdom
Status:
Recruiting
Start date:
August 14, 2023
Completion date:
July 21, 2033
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05803941
