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Study on Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan for Adults with Prostate Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety of a treatment for prostate cancer. The treatment being investigated is called lutetium (177Lu) vipivotide tetraxetan, also known by its code name AAA617. This medication is given as a solution for injection or infusion, which means it is administered directly into the bloodstream through a vein. The purpose of the study is to gather more information about the long-term effects of this treatment, especially any known or potential risks.

Participants in this study will be monitored for up to 10 years after receiving their first dose of the treatment. The study aims to observe any side effects, such as myelosuppression (a condition where bone marrow activity is decreased, leading to fewer blood cells), renal failure (a condition where the kidneys stop working properly), xerostomia (dry mouth), xerophthalmia (dry eyes), and the development of other serious conditions like myelodysplastic syndrome and acute myeloid leukemia. The study will also look for any other serious adverse reactions that may occur.

Throughout the study, researchers will collect data on the incidence and proportion of participants experiencing these side effects, as well as any changes in laboratory values. The study will also track the incidence and proportion of deaths among participants. This information will help to better understand the long-term safety of lutetium (177Lu) vipivotide tetraxetan in treating prostate cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after receiving at least one dose of AAA617 in a previous clinical trial for prostate cancer.

    Eligibility is confirmed based on prior trial requirements.

  2. Step 2

    Treatment administration

    The medication used is Pluvicto, a solution for injection or infusion.

    The active substance is lutetium (177Lu) vipivotide tetraxetan.

    Administration is done intravenously, meaning it is injected directly into a vein.

  3. Step 3

    Monitoring and follow-up

    The study aims to monitor long-term safety for up to 10 years after the first dose.

    Focus is on identifying known or potential risks such as myelosuppression (a decrease in bone marrow activity), renal failure, dry mouth, dry eyes, and secondary cancers like myelodysplastic syndrome and acute myeloid leukemia.

    Other serious adverse reactions are also monitored.

  4. Step 4

    Data collection

    The primary goal is to record the incidence and proportion of participants experiencing selected adverse events and serious adverse events.

    Changes in laboratory values are also tracked.

  5. Step 5

    Study duration

    The study is expected to continue until July 7, 2033.

    Recruitment for the study began on October 23, 2023.

Who can join the trial?

5 criteria

  • The patient must be male.
  • The patient must have prostate cancer.
  • The patient must have received at least one dose of a treatment called AAA617 in a previous clinical trial sponsored by Novartis for prostate cancer.
  • The patient must have completed all the requirements of the previous trial to be eligible for this study.
  • The patient must be within the specified age range for the study.

Who cannot join the trial?

2 criteria

  • Only male patients can participate. Female patients are not eligible.
  • Patients with conditions that make them vulnerable are not eligible.
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Investigated drugs

AAA617 is a medication being studied for its long-term safety in adults with prostate cancer. It is used to treat prostate cancer by delivering targeted radiation therapy. The study aims to monitor any known or potential risks associated with this treatment, such as effects on blood cell production, kidney function, dry mouth, dry eyes, and the development of other cancers.

What is already known about the treatment

Lutetium (177Lu) vipivotide tetraxetan – This medication is administered intravenously and is currently being studied in a Phase IV clinical trial to assess its long-term safety in treating prostate cancer. It is used primarily for patients with prostate cancer, aiming to target and destroy cancer cells. The drug works by delivering targeted radiation to cancer cells, which helps to minimize damage to surrounding healthy tissue. It is classified as a radiopharmaceutical, which means it combines a radioactive component with a molecule that specifically targets cancer cells.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. This cancer often grows slowly and may initially cause no symptoms. As it progresses, it can lead to difficulties with urination, blood in the urine, or pelvic discomfort. In some cases, it may spread to other parts of the body, such as the bones or lymph nodes. The progression can vary greatly among individuals, with some experiencing rapid advancement and others having a more indolent course.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503208-94-00Protocol codeCAAA617A12402Estimated enrolment775 patientsSponsorNovartis Pharma AG

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