Status:
RECRUITING
Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
PHASE4
Brief 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 17...
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, Phas...
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.
Exclusion
- \- Inability to complete the needed investigational examinations due to any reason.
Key Trial Info
Start Date :
August 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 21 2033
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT05803941
Start Date
August 14 2023
End Date
July 21 2033
Last Update
April 24 2025
Active Locations (54)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
St. Joseph Hospital
Orange, California, United States, 92686
3
Providence Saint Johns Health Ctr
Santa Monica, California, United States, 90404
4
University of Colorado
Aurora, Colorado, United States, 80045