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

NCT05803941 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-04-24

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

AAA617

Long-term follow-up (LTFU) safety study of adult participants with prostate cancer that have received at least one dose of AAA617 from parent interventional Novartis sponsored clinical trials.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-14
Primary Completion
2033-07-20
Completion
2033-07-21
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05803941 on ClinicalTrials.gov