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Study on Lutetium (177Lu) Vipivotide Tetraxetan for Men with Progressive 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 (mCRPC). 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 is comparing two different treatments for this condition. One treatment involves a medication called 177Lu-PSMA-617, which is a type of radiopharmaceutical. Radiopharmaceuticals are drugs that contain radioactive substances and are used to treat certain types of cancer. The other treatment involves changing the current therapy that targets androgen receptors, which are proteins in the body that respond to male hormones like testosterone.

The purpose of the study is to see if the treatment with 177Lu-PSMA-617 can help delay the progression of the cancer or extend the time before the cancer worsens, compared to the alternative therapy. Participants in the study will receive either the radiopharmaceutical treatment or a change in their current androgen receptor-directed therapy. The study will last for a period of time, during which participants will be monitored regularly to assess the effects of the treatment on their cancer.

In addition to the main treatments, the study will also involve the use of other medications such as abiraterone acetate and enzalutamide, which are commonly used in treating prostate cancer. These medications work by blocking the effects of male hormones that can promote the growth of cancer cells. The study aims to provide valuable information on the effectiveness of these treatments in managing metastatic castration-resistant 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

    Upon joining the study, informed consent is required. This means agreeing to participate after understanding the study details.

    Eligibility is confirmed based on specific health criteria, including adequate organ function and a positive scan result for PSMA-positive prostate cancer.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: one receiving 177Lu-PSMA-617 and the other undergoing a change in androgen receptor-directed therapy (ARDT).

  3. Step 3

    Treatment phase

    For those receiving 177Lu-PSMA-617, the treatment is administered intravenously. The frequency and duration depend on the study protocol.

    Participants in the ARDT group may receive medications such as abiraterone acetate or enzalutamide, taken orally. Dosage and frequency are determined by the treating physician.

  4. Step 4

    Monitoring and assessments

    Regular monitoring includes imaging tests to track disease progression and blood tests to assess health status.

    Participants are evaluated for any side effects or adverse events related to the treatment.

  5. Step 5

    Follow-up

    After completing the treatment phase, follow-up visits are scheduled to continue monitoring health and disease status.

    The study aims to assess outcomes such as progression-free survival and overall survival.

Who can join the trial?

17 criteria

  • You must sign a form agreeing to participate in the study.
  • You should have recovered from any serious side effects from previous treatments, except for hair loss.
  • Your body must be working well enough, including:
    • Bone marrow: Enough white blood cells and platelets, and a good level of hemoglobin (a protein in red blood cells).
    • Liver: Normal levels of bilirubin (a substance made by the liver) and liver enzymes (ALT or AST).
    • Kidneys: A good filtration rate, which shows how well your kidneys are working.
    • Your albumin level (a protein in the blood) should be at least 2.5 g/dL.
    • You should be a candidate for a change in hormone therapy, as decided by your doctor.
    • You must be 18 years or older.
    • Your performance status (how well you can carry out daily activities) should be between 0 and 1 on the ECOG scale.
    • You must have confirmation of prostate cancer through tests.
    • You need to have a positive result on a specific type of scan called a 68Ga-PSMA-11 PET/CT scan.
    • Your testosterone levels should be very low, like those after castration.
    • You should have progressed only once on a specific type of hormone therapy called second-generation ARDT.
    • Your prostate cancer should be progressing, shown by:
      • Increasing levels of PSA (a protein made by the prostate).
      • Growth of soft tissue tumors.
      • New bone lesions (areas of cancer in the bone).
      • You must have at least one area of cancer that can be seen on a scan before starting the study.

Who cannot join the trial?

4 criteria

  • Patients who do not have **PSMA-positive metastatic castration-resistant prostate cancer** cannot participate. This means the cancer must have spread to other parts of the body and not respond to treatments that lower testosterone.
  • Patients who are not male cannot participate. This study is only for male patients.
  • Patients who are not within the specified age range cannot participate. The study is for adults, typically those who are middle-aged or older.
  • Patients who are part of a vulnerable population cannot participate. This usually refers to groups who might need special protection or care.
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Investigated drugs

  • 177Lu-PSMA-617

    is a targeted therapy used in the treatment of prostate cancer. It combines a radioactive component with a molecule that specifically targets prostate-specific membrane antigen (PSMA) found on prostate cancer cells. This allows the radiation to be delivered directly to the cancer cells, potentially reducing their growth and spread.

  • Androgen Receptor-Directed Therapy (ARDT)

    is a treatment approach for prostate cancer that focuses on blocking the effects of androgens, which are male hormones that can promote the growth of prostate cancer cells. This therapy aims to slow down or stop the progression of the cancer by interfering with the cancer cells' ability to use these hormones.

What is already known about the treatment

177Lu-PSMA-617 – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating PSMA-positive metastatic castration-resistant prostate cancer. It is not yet widely used in standard medical practice but shows promise in ongoing research. The main therapeutic indication is for patients with this specific type of prostate cancer who have not responded to other treatments. At the molecular level, 177Lu-PSMA-617 targets the prostate-specific membrane antigen (PSMA) on cancer cells, delivering radiation directly to the tumor, which helps to destroy cancer cells while minimizing damage to surrounding healthy tissue. It is classified as a radiopharmaceutical agent.

Investigated diseases

PSMA-positive metastatic castration-resistant prostate cancer – 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 the surface of cancer cells, which can be targeted for imaging and treatment. The disease typically progresses by spreading to other parts of the body, such as bones and lymph nodes. Patients may experience symptoms related to the spread of cancer, including bone pain and urinary issues. The progression of the disease is often monitored through imaging tests and prostate-specific antigen (PSA) levels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507772-50-00Protocol codeCAAA617B12302Estimated enrolment511 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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