- Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer — Recruiting • Phase IV • Oncology • NCT05803941.
- What is being tested: Long-term safety profile of lutetium (177Lu) vipivotide tetraxetan (AAA617), a radioligand therapy targeting PSMA-positive prostate cancer, through post-marketing surveillance to characterize known and potential risks.
- Patient eligibility overview: Participants with prostate cancer who have received or are eligible to receive lutetium (177Lu) vipivotide tetraxetan treatment, typically those with PSMA-positive disease suitable for radioligand therapy.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.