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.
Worldwide Contacts
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