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

RECRUITINGPhase 4Sponsored by Novartis Pharmaceuticals
Actively Recruiting
PhasePhase 4
SponsorNovartis Pharmaceuticals
Started2023-08-14
Est. completion2033-07-20
Eligibility
Age18 Years – 100 Years
SexMALE
Healthy vol.Accepted
Locations24 sites
View on ClinicalTrials.gov →

NCT05803941

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.

Eligibility

Age: 18 Years – 100 YearsSex: MALEHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

\- Inability to complete the needed investigational examinations due to any reason.

Conditions2

CancerProstate Cancer

Locations24 sites

Mayo Clinic Arizona
Scottsdale, Arizona, 85259
480-301-8300
St. Joseph Hospital
Orange, California, 92686
Timothy Byun
Providence Saint Johns Health Ctr
Santa Monica, California, 90404
Przemyslaw Twardowski
University of Colorado
Aurora, Colorado, 80045
Muthiah Nachiappan
Hartford Hospital
Hartford, Connecticut, 06102
Andrew Salner

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