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Study on the Effects of Darolutamide and Drug Combination for Patients with Metastatic Hormone-Naïve 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 hormone-naïve prostate cancer, a type of prostate cancer that has spread to other parts of the body but has not yet been treated with hormone therapy. The study will explore the effects of different medications, including darolutamide (also known as ODM-201 or BAY 1841788), goserelin acetate, leuprorelin acetate (also known as leuprolide acetate), apalutamide (also known as ARN-509), relugolix (also known as TAK-385), degarelix, enzalutamide (also known as MDV3100), abiraterone, and triptorelin acetate. These medications are used in hormone therapy to manage prostate cancer by blocking or reducing the effects of male hormones that can promote cancer growth.

The purpose of the study is to compare two approaches to hormone therapy: intermittent maximum androgen blockade (iMAB) and continuous maximum androgen blockade (cMAB). The study aims to determine the benefits and risks of these approaches in patients who have shown a significant response to initial hormone therapy. Participants will be randomly assigned to either continue their hormone therapy without interruption or to have breaks in their treatment. The study will monitor how long patients can go without restarting hormone therapy and compare the overall survival rates between the two groups.

Throughout the study, participants will be observed for changes in their quality of life, including physical functioning, sexual activity, and pain levels. The study will also track the time it takes for patients to need additional prostate cancer treatments and monitor their testosterone and PSA (prostate-specific antigen) levels. The trial will help determine if taking breaks in hormone therapy can maintain the same level of cancer control as continuous treatment while potentially improving the quality of life for patients.

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, you will be randomly assigned to one of two groups: the **intermittent maximum androgen blockade (iMAB)** group or the **continuous maximum androgen blockade (cMAB)** group.

    This assignment will determine the course of your treatment during the trial.

  2. Step 2

    Treatment phase

    If you are in the **iMAB** group, your treatment will be paused after achieving a deep response, defined as a **PSA level** of 0.2 ng/mL or lower, for a period of up to one year.

    If you are in the **cMAB** group, you will continue receiving treatment without interruption.

    The medications used in this trial may include **darolutamide**, **goserelin acetate**, **leuprorelin acetate**, **apalutamide**, **relugolix**, **enzalutamide**, **abiraterone**, and **triptorelin acetate**. These medications are administered either orally or through injections.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, regular assessments will be conducted to monitor your health and the effectiveness of the treatment.

    These assessments will include measuring your **PSA levels**, checking your testosterone levels, and evaluating your overall health and quality of life.

    You will be asked to complete questionnaires about your physical functioning, sexual activity, pain, and fatigue.

  4. Step 4

    End of treatment evaluation

    At the end of the treatment phase, a comprehensive evaluation will be conducted to assess the outcomes of the trial.

    This evaluation will include a review of your **PSA levels**, testosterone levels, and overall survival.

    The results will help determine the effectiveness and safety of the intermittent treatment approach compared to continuous treatment.

  5. Step 5

    Follow-up

    After the treatment phase, follow-up assessments will continue for up to three years to monitor long-term effects and outcomes.

    These follow-ups will include regular health check-ups and assessments of your quality of life.

    The information gathered during this period will contribute to understanding the long-term benefits and risks of the treatment strategies.

Who can join the trial?

8 criteria

  • Must be a male patient.
  • Must have metastatic hormone-naïve prostate cancer (mHNPC). This means the prostate cancer has spread to other parts of the body but has not been treated with hormone therapy before.
  • Must have been treated with ADT (Androgen Deprivation Therapy) for 6 to 12 months. ADT is a treatment that reduces male hormones to slow the growth of cancer.
  • Must have been treated with an ARpI (Androgen Receptor Pathway Inhibitor) for 6 to 12 months. ARpI is a medication that blocks the action of male hormones.
  • Must have a PSA level of ≤ 0.2 ng/mL. PSA (Prostate-Specific Antigen) is a protein produced by the prostate, and its level is used to monitor prostate cancer.
  • Can have either synchronous (at the same time) or metachronous (at different times) metastases, which means the cancer has spread to other parts of the body.
  • Can have either high volume or low volume/risk cancer, which refers to the amount and severity of cancer spread.
  • Must provide written informed consent before joining the study. This means agreeing to participate after understanding the study details.

Who cannot join the trial?

3 criteria

  • Patients with **metastatic hormone-naïve prostate cancer (mHNPC)** cannot participate. This means the cancer has spread to other parts of the body, but the patient has not yet received hormone therapy.
  • Only **male** patients are eligible for this study.
  • Patients who are part of a **vulnerable population** are not eligible. This generally refers to groups who may have limited ability to give informed consent or are at higher risk of being exploited.
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Investigated drugs

  • Androgen Deprivation Therapy (ADT)

    is a treatment used to lower the levels of male hormones, such as testosterone, in the body. These hormones can help prostate cancer cells grow, so reducing their levels can slow down or stop the growth of the cancer. In this trial, ADT is used to help manage prostate cancer by reducing hormone levels.

  • Androgen Receptor Pathway Inhibitors (ARpI)

    are medications that block the action of male hormones on prostate cancer cells. These inhibitors prevent the hormones from attaching to the receptors on the cancer cells, which can stop the cells from growing and dividing. In this trial, ARpIs are used alongside ADT to enhance the treatment's effectiveness in controlling prostate cancer.

What is already known about the treatment

Androgen Receptor Pathway Inhibitors (ARpI) – These medications are typically administered orally and are used in the treatment of metastatic hormone-naïve prostate cancer (mHNPC). They are currently well-established in medical practice and literature, particularly in the context of prostate cancer treatment. The main therapeutic indication for ARpIs is to manage prostate cancer by blocking the action of male hormones that can promote cancer growth. At the molecular level, ARpIs work by inhibiting the androgen receptor pathway, which is crucial for the growth and survival of prostate cancer cells. Pharmacologically, they are classified as hormone antagonists, specifically targeting the androgen receptor to prevent cancer progression.

Investigated diseases

Metastatic hormone-naïve prostate cancer – This is a type of prostate cancer that has spread beyond the prostate gland to other parts of the body, such as bones or lymph nodes, but has not yet been treated with hormone therapy. The disease progresses as cancer cells grow and multiply, forming new tumors in other areas. Initially, the cancer cells are sensitive to hormones, particularly testosterone, which fuels their growth. Over time, the cancer may become more aggressive and less responsive to hormonal signals. As the disease advances, symptoms such as bone pain, urinary issues, and fatigue may develop. The progression can vary widely among individuals, with some experiencing rapid changes and others having a slower course.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506817-23-01Protocol codeEORTC-2238-GUCGEstimated enrolment1 404 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

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