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Study Comparing [177Lu]LU-PSMA-I&T and Hormone Therapy for Patients 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 (mCRPC). This is a form of prostate cancer that continues to grow and spread even when the amount of male hormones in the body is reduced to very low levels. The study is comparing the effects of a new treatment called 177Lu-PSMA-I&T, which is a solution for injection, with existing hormone therapies. The hormone therapies being compared include Enzalutamide, Abiraterone Acetate, and Prednisone. The purpose of the study is to see if the new treatment can help patients live longer without their cancer getting worse.

Participants in the study will receive either the new treatment or one of the hormone therapies. The new treatment, 177Lu-PSMA-I&T, is given through an intravenous infusion, which means it is delivered directly into the bloodstream. The hormone therapies are taken orally, which means they are swallowed in the form of capsules or tablets. The study will monitor the participants over a period to see how their cancer responds to the treatments. The researchers will look at how long it takes for the cancer to progress, as well as other factors like overall survival and quality of life.

Throughout the study, participants will undergo regular check-ups and tests to track their health and the status of their cancer. These tests may include imaging scans and blood tests to measure specific markers related to prostate cancer. The study aims to provide valuable information on the effectiveness and safety of the new treatment compared to existing hormone therapies, potentially offering new hope for patients with this challenging form of 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

    Randomization

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the treatment with [177Lu]LU-PSMA-I&T, and the other group will receive hormone therapy. This process is called randomization and ensures that the study results are unbiased.

  2. Step 2

    Treatment administration

    If you are in the [177Lu]LU-PSMA-I&T group, you will receive the treatment through an intravenous infusion. This means the medication will be given directly into your vein. The frequency and duration of this treatment will be determined by the study protocol.

    If you are in the hormone therapy group, you will take medications such as enzalutamide or abiraterone acetate orally. These medications are taken daily, and the exact dosage will be provided by the study team. Additionally, you may be required to take prednisone orally as part of the hormone therapy regimen.

  3. Step 3

    Imaging and monitoring

    Throughout the study, you will undergo regular imaging tests to monitor the progression of your condition. This may include scans such as SPECT/CT imaging at various intervals after receiving the [177Lu]LU-PSMA-I&T treatment.

    You will also have regular blood tests to monitor your health and the effects of the treatment. These tests will help the study team assess how your body is responding to the treatment.

  4. Step 4

    Follow-up visits

    You will be required to attend follow-up visits as part of the study. These visits are important for monitoring your health and the effectiveness of the treatment. The frequency and schedule of these visits will be communicated to you by the study team.

  5. Step 5

    End of study

    At the end of the study, you will have a final assessment to evaluate the overall impact of the treatment on your condition. This will include a review of your imaging results, blood tests, and any other relevant health information.

Who can join the trial?

14 criteria

  • Must be a male aged 18 years or older.
  • Must be able to understand and provide signed written consent to participate.
  • Must be able to attend all required study visits and follow-up appointments.
  • Patients with HIV can participate if they are healthy and have a low risk of related health issues.
  • Patients with Hepatitis B (HBV) and Hepatitis C (HCV) can participate if their symptoms are well managed.
  • Must have a life expectancy of at least 6 months, as assessed by the study doctor.
  • Must be willing to start ARAT therapy (a type of hormone therapy) as determined by the study doctor.
  • If the patient has a partner who can become pregnant, they must use a reliable method of birth control during the study and for 6 months after the last dose of the study drug.
  • Must have a confirmed diagnosis of prostate adenocarcinoma (a type of prostate cancer) without a predominant small cell component.
  • Must have progressive disease, which can be shown by:
    • Increasing levels of PSA (a protein produced by the prostate) in the blood.
    • Progression of measurable disease or new bone lesions.
    • Must have had previous treatment with one next-generation androgen receptor (AR)-directed therapy, such as abiraterone, enzalutamide, apalutamide, or darolutamide, and must have progressed while on this therapy.
    • Must have a positive PSMA-PET scan (a type of imaging test used to detect prostate cancer).
    • Must have effective castration, meaning a serum testosterone level of less than 50 ng/dL, and plan to continue with ongoing medical or surgical castration.

Who cannot join the trial?

3 criteria

  • Patients who do not have metastatic Castration-Resistant Prostate Cancer (mCRPC) cannot participate. 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.
  • Only male patients can participate. Female patients are not eligible.
  • Patients who are considered part of a vulnerable population are not eligible. This means people who might be at a higher risk of harm or exploitation.
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Investigated drugs

  • [177Lu]LU-PSMA-I&T

    is a type of targeted therapy used in this clinical trial for patients with a specific kind of prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatments. This therapy works by delivering a radioactive substance directly to the cancer cells, which helps to destroy them while minimizing damage to the surrounding healthy tissue. The goal of using this treatment is to slow down the progression of the cancer and improve the patient's quality of life.

  • Hormone Therapy

    is another treatment option being compared in this trial. It is used to treat prostate cancer by reducing the levels of male hormones, like testosterone, which can help slow the growth of cancer cells. Hormone therapy can be administered in various forms, such as pills or injections, and is often used when the cancer has become resistant to initial treatments. The aim is to control the cancer's progression and alleviate symptoms associated with the disease.

What is already known about the treatment

[177Lu]LU-PSMA-I&T – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating metastatic castration-resistant prostate cancer (mCRPC). It is not yet widely used in standard medical practice, as it is still under investigation. The main purpose of this medication is to help improve the survival of patients by slowing down the progression of cancer that has spread and is resistant to hormone therapy. It works by targeting a specific protein found on prostate cancer cells, delivering radiation directly to the cancer cells to help destroy them. This medication is classified as a radiopharmaceutical, which means it uses radioactive substances to treat cancer.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer (mCRPC) – This is a form of prostate cancer that continues to progress despite treatments that lower testosterone levels. It is characterized by the spread of cancer cells beyond the prostate gland to other parts of the body, such as bones and lymph nodes. The disease progresses as cancer cells grow and multiply, often leading to increased pain and other symptoms. Over time, the cancer may become resistant to hormone therapy, which is initially used to control its growth. As the disease advances, patients may experience a range of symptoms related to the spread of cancer, including bone pain and urinary issues. The progression of mCRPC is typically monitored through imaging studies and blood tests to assess the extent of cancer spread and activity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501493-19-00Protocol codeCURLu177PSM0001Estimated enrolment400 patientsSponsorCurium Pet France

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