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Study on Docetaxel, Cabazitaxel, and Darolutamide for Men 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 treatments for metastatic castration-resistant prostate cancer, a type 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 effectiveness of different treatment combinations involving the medications docetaxel, cabazitaxel, and darolutamide. Docetaxel and cabazitaxel are given as solutions for infusion, which means they are administered directly into the bloodstream through a vein, while darolutamide is taken orally in the form of film-coated tablets. Darolutamide is also known by its code names ODM-201 and BAY 1841788.

The purpose of the study is to compare how well patients do when treated with either docetaxel or cabazitaxel alone versus when these are combined with darolutamide. Participants will be randomly assigned to receive one of these treatment options. The study will monitor the participants over a period of time to see how long they can live without the cancer getting worse, which is known as progression-free survival. Other aspects being observed include overall survival, time to cancer progression, and any side effects experienced during the treatment.

The trial will last for up to 52 weeks, during which participants will receive regular check-ups and assessments to track their health and the cancer's response to the treatment. The study aims to provide valuable information on the best treatment approach for men with this type of prostate cancer, potentially improving outcomes and quality of life for future patients. The study is expected to conclude in 2028.

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, you will be randomly assigned to one of the treatment groups. This means you will receive either a combination of medications or a single medication, depending on the group you are placed in.

  2. Step 2

    Treatment with docetaxel or cabazitaxel

    If you are assigned to receive docetaxel or cabazitaxel, these medications will be administered through an intravenous infusion. This means the medication will be given directly into your vein. The specific dosage and frequency will be determined by the study team based on your individual needs and the study protocol.

  3. Step 3

    Treatment with darolutamide

    If you are in the group receiving darolutamide, you will take this medication orally in the form of film-coated tablets. The dosage is 300 mg, and the frequency and duration will be specified by the study team.

  4. Step 4

    Monitoring and assessments

    Throughout the study, you will undergo regular monitoring and assessments to evaluate your health and the effectiveness of the treatment. This may include blood tests, imaging scans, and other evaluations as required by the study protocol.

  5. Step 5

    End of treatment

    At the end of the treatment period, you will have a final assessment to determine the outcome of the treatment. This will include a review of your health status and any changes in your condition.

  6. Step 6

    Follow-up

    After completing the treatment, you may be asked to participate in follow-up visits to monitor your long-term health and any lasting effects of the treatment. The frequency and duration of these visits will be determined by the study team.

Who can join the trial?

13 criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of progressive metastatic castration-resistant prostate cancer (mCRPC). This means the cancer has spread and is not responding to treatments that lower testosterone.
  • Must show signs of cancer progression, which can be one of the following:
    • Radiographic disease progression in soft tissue, meaning the cancer is growing as seen on imaging tests.
    • Radiographic disease progression in bone, shown by at least two new bone lesions on a bone scan.
    • PSA progression, which means an increase in prostate-specific antigen (PSA) levels, a marker used to track prostate cancer.
    • Must have had disease progression after treatment with at least one androgen receptor signaling inhibitor (ARSi), such as abiraterone, apalutamide, darolutamide, or enzalutamide.
    • Must have a WHO performance status of 2 or less, which is a measure of general well-being and ability to perform daily activities.
    • Must be able and willing to sign an Informed Consent Form before any study-related procedures.
    • Must have adequate blood, kidney, and liver function, as defined by specific medical tests:
      • Hemoglobin level of at least 6.0 mmol/L.
      • Platelet count of at least 100 x 109/L.
      • ALT/AST levels no more than 3 times the upper limit of normal, or 5 times if there are liver metastases.
      • Creatinine clearance of at least 50 ml/min, which measures kidney function.
      • Serum testosterone level of 1.7 nmol/L or less.

Who cannot join the trial?

3 criteria

  • Patients who do not have metastatic castration-resistant prostate cancer 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 in this study.
  • Patients who are part of a vulnerable population cannot participate. This means people who might be at a higher risk of harm or exploitation, such as those with limited decision-making capacity.
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Investigated drugs

  • Docetaxel

    is a type of chemotherapy drug used to treat various cancers, including prostate cancer. It works by stopping cancer cells from growing and dividing, which can help slow down or stop the progression of the disease.

  • Cabazitaxel

    is another chemotherapy medication used for treating prostate cancer, especially when other treatments have not been effective. Like docetaxel, it targets cancer cells and prevents them from multiplying, aiming to control the spread of the cancer.

  • Darolutamide

    is a medication used to treat prostate cancer by blocking the effects of male hormones that can promote the growth of cancer cells. It is often used in combination with other treatments to enhance their effectiveness in controlling the disease.

What is already known about the treatment

  • Docetaxel

    Docetaxel is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently used in the treatment of various cancers, including metastatic castration-resistant prostate cancer, and is well-documented in medical literature. The main therapeutic indication for docetaxel is to slow the growth of cancer cells. At the molecular level, it works by interfering with the microtubule structures within the cell, which are essential for cell division, thereby inhibiting cancer cell growth. It is classified as a taxane, which is a type of chemotherapy drug.

  • Cabazitaxel

    Cabazitaxel is also administered as an intravenous infusion, delivered directly into the bloodstream through a vein. It is used in the treatment of metastatic castration-resistant prostate cancer and is recognized in medical literature for its effectiveness in this area. The primary therapeutic use of cabazitaxel is to treat cancer that has progressed despite other treatments. It acts at the molecular level by disrupting the microtubule network in cells, preventing them from dividing and growing. Cabazitaxel is classified as a taxane, similar to docetaxel, and is a chemotherapy medication.

  • Darolutamide

    Darolutamide is taken orally in the form of tablets, making it easy to administer at home. It is currently used in the treatment of metastatic castration-resistant prostate cancer and is supported by medical research. The main therapeutic indication for darolutamide is to inhibit the growth of prostate cancer cells. It works at the molecular level by blocking the action of androgens, which are hormones that can promote the growth of prostate cancer cells. Darolutamide is classified as an androgen receptor inhibitor, a type of hormone therapy.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread to other parts of the body despite treatments that lower testosterone levels. The disease progresses as cancer cells become resistant to hormonal therapy, which is initially used to control the growth of prostate cancer. Over time, the cancer may spread to bones, lymph nodes, or other organs, leading to various symptoms depending on the areas affected. As the disease advances, patients may experience increased pain, particularly in the bones, and other complications related to the spread of cancer. The progression of the disease is often monitored through imaging tests and blood tests that measure prostate-specific antigen (PSA) levels. The disease is characterized by its resistance to conventional hormone therapy, necessitating alternative treatment approaches.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516939-28-00Protocol codeDAROTAXELEstimated enrolment245 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

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