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Study on Lutetium (177Lu) Vipivotide Tetraxetan to Delay Recurrence in Adult Men with PSMA-Positive Oligometastatic 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 a type of prostate cancer known as oligometastatic prostate cancer, which is a form of cancer that has spread to a limited number of other parts of the body. The study is investigating the effects of a treatment called lutetium (177Lu) vipivotide tetraxetan, also known by its code name AAA617. This treatment is compared to simply observing the patients without any active treatment to see if it can delay the return of the disease or the need for further treatment.

The trial involves adult male patients who have prostate cancer that shows positive results for a specific marker called prostate-specific membrane antigen (PSMA). The study uses a special type of imaging called Positron Emission Tomography (PET) to identify the presence of PSMA in the cancer. Patients will receive either the treatment or be placed under observation, and their progress will be monitored over time to see how the treatment affects the spread of cancer.

Participants in the study will undergo regular imaging tests, such as CT or MRI scans, to track the presence of cancer in the body. The main goal is to determine how long patients can remain free from new cancer growth or the need for additional treatment. The study will also look at other factors, such as the time it takes for the cancer to progress and the overall health and quality of life of the participants. The trial is expected to continue until 2030, with recruitment starting in 2024.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed through a process called randomization. This means being assigned to one of two groups: one receiving the treatment and the other under observation.

  2. Step 2

    Treatment administration

    If assigned to the treatment group, the medication lutetium (177Lu) vipivotide tetraxetan is administered. This is given as a solution for injection or infusion through a vein (intravenous use).

    The dosage and frequency of administration are determined by the study protocol and medical team.

  3. Step 3

    Observation period

    Participants in the observation group do not receive the study medication but are monitored for any changes in their condition.

  4. Step 4

    Regular assessments

    Throughout the study, regular assessments are conducted to monitor health status. These include imaging tests like CT or MRI scans and bone scans to check for any new metastasis or changes in existing conditions.

    Blood tests are performed to measure prostate-specific antigen (PSA) levels, which help in assessing disease progression.

  5. Step 5

    Safety monitoring

    Safety is closely monitored by tracking any side effects or adverse events. This includes changes in laboratory values, vital signs, and electrocardiograms (ECGs).

    Any significant changes are recorded and addressed by the medical team.

  6. Step 6

    End of study

    The study is expected to conclude by June 3, 2030. At this point, final assessments are conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of prostate cancer through a tissue sample test before joining the study.
  • Must have prostate cancer that has returned after initial treatment, which could include surgery, radiation, or brachytherapy. This return is shown by specific levels of a protein called PSA in the blood.
  • Must have a type of prostate cancer called oligometastatic prostate cancer (OMPC), which means having 5 or fewer cancer spots that show up on a special scan called PSMA PET/CT.
  • At least one of these cancer spots must be a distant metastasis, meaning it has spread to a part of the body far from the original cancer site.
  • Must have a negative result on regular imaging tests for cancer that has spread far from the prostate. This means the tests should not show clear signs of cancer spread.
  • All cancer spots found during screening should be treatable with a type of radiation therapy called SBRT.
  • Must have a testosterone level higher than 100 ng/dL, which means the body is producing normal levels of this hormone.
  • Only male participants are eligible for this study.

Who cannot join the trial?

4 criteria

  • Only male participants can join the study. Female participants are not eligible.
  • Participants must have oligometastatic prostate cancer (OMPC). This means the cancer has spread to a few other parts of the body.
  • Participants must be adults. This means they should be 18 years or older.
  • The study is not open to vulnerable populations. This means people who might need special protection or care are not eligible.
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Investigated drugs

Lutetium (177Lu) vipivotide tetraxetan (AAA617) is a medication being studied for its potential to delay the progression of prostate cancer in men. It is used in patients with a specific type of prostate cancer that shows positive results on a PSMA PET scan. This medication works by delivering targeted radiation to cancer cells, which may help to slow down or stop the growth of the cancer.

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 effectiveness in treating oligometastatic prostate cancer. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication is to delay castration or disease recurrence in patients with prostate-specific membrane antigen (PSMA) positive oligometastatic prostate cancer. At the molecular level, it works by delivering targeted radiation to cancer cells expressing PSMA, thereby damaging and potentially killing these cells. It is classified as a radiopharmaceutical agent.

Investigated diseases

Oligometastatic Prostate Cancer – Oligometastatic prostate cancer is a form of prostate cancer where the disease has spread beyond the prostate gland but is limited to a few metastatic sites, typically fewer than five. This condition represents an intermediate state between localized prostate cancer and widespread metastatic disease. The cancer cells may spread to bones or other soft tissues, but the number of these metastatic sites is relatively small. The progression of oligometastatic prostate cancer can vary, with some cases remaining stable for extended periods, while others may progress to more widespread metastasis. The disease is often monitored through imaging techniques such as CT scans, MRIs, and bone scans to assess the extent and progression of metastasis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502956-29-00Protocol codeCAAA617D12302Estimated enrolment458 patientsSponsorNovartis Pharma AG

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