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

• Status: Not yet recruiting
• Trial end date: 2033-07-07
• Target enrollment: 0
• Participant gender: Male

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: 177Lu-PSMA-617

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.