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Study on the Safety and Effects of Lutetium (177Lu) Vipivotide Tetraxetan in Patients with Advanced Prostate Cancer and Different Levels of Kidney Function

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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 a type of prostate cancer known as Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). This is a form of prostate cancer that continues to grow and spread despite treatments that lower testosterone levels. The study will use a treatment called lutetium (177Lu) vipivotide tetraxetan, also known by its code name AAA617. This treatment is a special type of medicine that is injected into the bloodstream and is designed to target and treat cancer cells.

The purpose of the study is to understand how this treatment behaves in the body, especially in patients with different levels of kidney function, ranging from normal to severely impaired. Participants will receive the treatment through an injection, and the study will monitor how the medicine spreads in the body, how safe it is, and how well it is tolerated by patients. The study will also look at how the treatment affects the kidneys and other organs over time.

Throughout the study, participants will undergo various tests and scans to track the treatment's effects and any side effects. These tests will help researchers gather important information about the treatment's safety and effectiveness. The study aims to provide valuable insights into how lutetium (177Lu) vipivotide tetraxetan can be used to treat this challenging form of prostate cancer, especially in patients with different kidney health conditions.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Eligibility criteria include a performance status score between 0 and 2, a positive PET/CT scan, and specific testosterone levels. Progressive prostate cancer must be documented, and kidney function is assessed using eGFR values.

  2. Step 2

    Baseline measurements

    Baseline measurements are taken to establish a starting point for the study. These include blood tests, imaging scans, and assessments of kidney function.

    The primary focus is on measuring the absorbed radiation dose in the kidneys and other organs, as well as the concentration of the study drug in the blood.

  3. Step 3

    Medication administration

    The study involves the administration of two medications: gozetotide and lutetium (177Lu) vipivotide tetraxetan. Both are given as solutions for injection or infusion through a vein.

    The dosage and frequency of administration are determined by the study protocol and are based on individual health assessments.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes tracking any side effects and changes in laboratory values, vital signs, and heart function.

    Follow-up visits are scheduled to evaluate the effectiveness of the treatment and to make any necessary adjustments to the dosage or treatment plan.

  5. Step 5

    End of study evaluation

    At the end of the study, a comprehensive evaluation is performed to assess the overall impact of the treatment on prostate cancer progression and kidney function.

    Final measurements are compared to baseline data to determine any changes in health status and to evaluate the success of the treatment.

Who can join the trial?

12 criteria

  • Must be a male patient.
  • Have a type of prostate cancer called Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC).
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which is a way to measure how well you can perform daily activities.
  • Have a positive result on a special scan called 68Ga-PSMA-11 PET/CT, which helps to see cancer in the body.
  • Have a castrate level of testosterone in the blood, which means very low testosterone levels (less than 50 ng/dL or 1.7 nmol/L).
  • Show signs of cancer getting worse, which can be seen by:
    • Increasing levels of a protein called Prostate-Specific Antigen (PSA) in the blood.
    • Growth of cancer in soft tissues, which means the size of cancer spots is getting bigger.
    • New or worsening cancer spots in the bones.
    • Have stable kidney health, meaning no big changes in kidney function in the last 4 weeks.
    • Have specific levels of kidney function measured by a test called eGFR:
      • Normal kidney function: eGFR of 90 mL/min or higher.
      • Moderate kidney issues: eGFR between 30 to 59 mL/min.
      • Severe kidney issues: eGFR between 15 to 29 mL/min.

Who cannot join the trial?

3 criteria

  • Patients who do not have Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Patients who are female, as the study is only for male participants.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

AAA617 is a medication being studied for its effects on patients with prostate cancer that has spread and is resistant to standard hormone therapy. This medication is designed to target and bind to specific proteins found on prostate cancer cells, allowing it to deliver radiation directly to the cancer cells. The study aims to understand how the medication is distributed in the body, how safe it is, and how well patients tolerate it, especially in those with different levels of kidney function.

What is already known about the treatment

Lutetium (177Lu) vipivotide tetraxetan – This medication is administered intravenously and is currently being studied in clinical trials for its effects on patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), particularly those with varying levels of renal function. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication is for treating advanced prostate cancer that has spread and is resistant to hormonal therapy. At the molecular level, it works by delivering targeted radiation to cancer cells expressing the PSMA protein, thereby damaging and killing these cells. It is classified as a radiopharmaceutical, which is a type of drug that contains radioactive substances used for diagnosis or treatment.

Investigated diseases

Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) – This is a type of prostate cancer that continues to grow and spread despite treatments that lower testosterone levels. It is characterized by the presence of prostate-specific membrane antigen (PSMA) on cancer cells, which can be targeted for imaging and therapy. The disease often spreads to bones and other organs, making it more challenging to manage. Patients with this condition may experience symptoms such as bone pain, urinary issues, and fatigue. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower course. The focus of research often includes understanding how the disease progresses in individuals with different levels of kidney function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503925-20-00Protocol codeCAAA617A12202Estimated enrolment20 patientsSponsorNovartis Pharma AG

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