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Study on the Safety and Effects of Lutetium (177Lu) Vipivotide Tetraxetan in Adults with Metastatic Castration-Resistant 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 metastatic castration-resistant prostate cancer. This is a form of prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. The study will explore the effects of a treatment called lutetium (177Lu) vipivotide tetraxetan, also known by its code name AAA617. This treatment is given as a solution for injection or infusion and is designed to target and deliver radiation directly to cancer cells.

The purpose of the study is to understand how the body processes this treatment, as well as to evaluate its safety and how well it is tolerated by patients. Participants in the study will receive the treatment for up to 12 cycles. During the study, researchers will monitor how the treatment is distributed in the body and its effects on organs and tumors. They will also keep track of any side effects or adverse reactions that may occur.

In addition to monitoring the treatment's distribution and safety, the study will also assess how the treatment affects the cancer's progression and the overall health of the participants. This includes measuring changes in prostate-specific antigen (PSA) levels, which can indicate how the cancer is responding to the treatment. The study aims to provide valuable information that could help improve treatment options for patients with this type of prostate cancer in the future.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, performance status, and prostate cancer diagnosis.

    A positron emission tomography-computed tomography (PET/CT) scan is performed to check for PSMA-positive lesions.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of lutetium (177Lu) vipivotide tetraxetan.

    The dosage is 7.4 gigabecquerels (GBq) with a variation of plus or minus 10%.

    The treatment is given intravenously, which means it is injected directly into a vein.

  3. Step 3

    Treatment cycles

    The treatment is administered in cycles, with a maximum of 12 cycles planned.

    Each cycle involves a single administration of the medication, followed by a period of observation and recovery.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess the safety and tolerability of the treatment.

    This includes tracking any side effects and measuring the radiation dose absorbed by organs and tumors.

  5. Step 5

    Follow-up assessments

    Follow-up assessments are performed to evaluate the response to treatment.

    These assessments include imaging tests, blood tests, and evaluations of prostate-specific antigen (PSA) levels.

  6. Step 6

    Completion of trial

    The trial is expected to conclude by February 23, 2028.

    Final assessments will be conducted to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

6 criteria

  • Participants must be adults who are **18 years or older**.
  • Participants must have an **ECOG performance status** of **0 or 1**. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • Participants must have a confirmed diagnosis of **adenocarcinoma of the prostate**, which is a type of prostate cancer.
  • Participants must be **PSMA-positive** based on specific imaging tests called **PET/CT scans**. This means the cancer shows certain markers that can be detected by these scans.
  • Participants must have a **castrate level of testosterone**, which means very low levels of testosterone in the blood, achieved either through medication or surgery.
  • Participants must have experienced disease progression only once after using certain medications known as **second generation ARPIs**. These include drugs like abiraterone, enzalutamide, darolutamide, or apalutamide.

Who cannot join the trial?

5 criteria

  • Patients who have received taxane-based chemotherapy before cannot participate. Taxane is a type of cancer treatment.
  • Patients with severe kidney problems are not eligible. Mild kidney issues are acceptable.
  • Patients who do not have progressive PSMA-positive mCRPC are excluded. PSMA-positive means the cancer cells have a specific marker that can be targeted by treatment.
  • Only male patients can participate, so female patients are excluded.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
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Investigated drugs

AAA617 is a medication being studied for its effects on prostate cancer that has spread and is resistant to standard hormone therapy. This medication is given to patients who have not yet received chemotherapy. The study aims to understand how the body processes this medication, as well as its safety and how well patients can tolerate it.

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 safety and effectiveness in treating metastatic castration-resistant prostate cancer. It is a radiopharmaceutical that targets prostate-specific membrane antigen (PSMA) on cancer cells, delivering targeted radiation to destroy them. The main therapeutic indication is for patients with prostate cancer that has spread and is resistant to hormonal therapy. As a radioligand therapy, it belongs to the pharmacological class of targeted radiotherapies, offering a novel approach to treating advanced prostate cancer by directly targeting cancer cells while sparing healthy tissue.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to progress despite treatments that lower testosterone levels. It has spread to other parts of the body, such as bones or lymph nodes, beyond the prostate gland. The disease is characterized by its resistance to hormonal therapy, which is typically used to manage prostate cancer. As the cancer advances, it may cause symptoms such as pain, fatigue, and urinary issues. 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 cancer spreads and finding ways to manage its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512338-13-00Protocol codeCAAA617A12101Estimated enrolment106 patientsSponsorNovartis Pharma AG

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