Authorised Therapeutic use (Phase IV) Prostate cancer

A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of lutetium (177Lu) vipivotide tetraxetan in Adult Participants with Prostate Cancer

EU CTIS ID: 2023-503208-94-00

What this study is testing

Further characterize the long-term outcome (for up to 10 years after the first dose of AAA617) of 1) known or potential risks of AAA617 including myelosuppression, renal failure, xerostomia, xerophthalmia, and secondary malignancies including myelodysplastic syndrome and acute myeloid leukemia (MDS/AML) and 2) other AAA617 causally related serious adverse events

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

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

The study team makes the final eligibility decision.

Where it's taking place

  • Singapore
  • Hong Kong
  • Taiwan
  • Switzerland
  • Japan
  • Canada
  • China
  • United States
  • United Kingdom
  • Korea, Republic of

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Singapore; Hong Kong; Taiwan; Switzerland; Japan; Canada and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.