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

Prostate Cancer

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 serious adverse reaction(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.

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Participation Requirements

  • Sex:

    MALE

  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. 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.
3. Willingness of sexually active participant to use a condom during intercourse for up to 14 weeks from the last dose of AAA617 treatment administered on the parent study.

Exclusion Criteria:

1. Inability to complete the needed investigational examinations due to any reason.

Study Location

Novartis Investigative Site
Novartis Investigative Site
Montreal, Quebec
Canada

Contact Study Team

Study Sponsored By
Novartis
Participants Required
More Information
Study ID: NCT05803941