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Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Prostate Cancer

This study is looking at the long-term safety of a drug called lutetium (177Lu) vipivotide tetraxetan (also known as AAA617) in people with prostate cancer. You could join this study if you are an adult man (18-100 years old) who has already received at least one dose of AAA617 in a previous Novartis-sponsored clinical trial for prostate cancer. The main goal is to track any side effects (Adverse Events or AEs) and serious side effects (Serious Adverse Events or SAEs) that might happen for up to 10 years after your first dose of AAA617. This study is currently unclear about its recruitment status and plans to enroll about 700 participants.

Study design
This is a global, multi-center study focused on long-term safety. It will follow approximately 700 adult participants who have previously received AAA617.
What's involved
You will have visits every 6-8 months to monitor for side effects and laboratory results. This monitoring will continue for up to 10 years from your first dose of AAA617 in the original treatment study.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years after their first dose of AAA617 in the parent treatment study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05803941

Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer

Recruiting
PHASE4Ages 18+Interventional
Novartis Pharmaceuticals
~700 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:AAA617

At a glance

Recruiting sites
54 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and percentage of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over every visit up to 10 years after 1st dose of AAA617 received in parent treatment study

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

54 sites across 35 states
Spain7
United Kingdom4
Germany3
California2
Louisiana2
Nebraska2
Texas2
Austria2

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
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Eligibility criteria

Inclusion

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.

What this trial measures

  • Number and percentage of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs)every visit up to 10 years after 1st dose of AAA617 received in parent treatment study

    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.