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NCT05803941 · ClinicalTrials.gov record · last posted 2026-06-04

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

StatusRecruiting
PhasePhase 4
Started2023-08-14
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 9 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 9 times since 2023-03-27; most recent amendment 2026-06-02. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-08-03
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT05803941
Lead Sponsor Novartis Pharmaceuticals
Conditions Prostate Cancer
Enrollment 700 participants
Start Date 2023-08-14
Primary Completion 2033-07-20 (estimated)
Study Completion 2033-07-21 (estimated)
Updated on ClinicalTrials.gov 2026-06-04