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Study on Adding Darolutamide to First-Line Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer Using a Drug Combination

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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 will explore the effects of adding a medication called darolutamide to the standard first-line treatment for this condition. Darolutamide is an androgenic inhibitor, which means it helps block male hormones that can promote cancer growth.

In addition to darolutamide, the study will involve other treatments that are commonly used for mCRPC. These include Cabazitaxel, a chemotherapy drug given as an infusion; Xofigo, a radioactive injection used to treat cancer that has spread to the bones; Docetaxel, another chemotherapy infusion; Lynparza, a tablet that targets cancer cells with specific genetic changes; and Lutathera, a radioactive infusion used for certain types of tumors. The purpose of the study is to assess how well darolutamide, when added to these treatments, can help delay the progression of the cancer as seen on imaging tests.

Participants in the study will receive either the standard treatment alone or the standard treatment plus darolutamide. The study will monitor how long it takes for the cancer to progress, as well as overall survival and other health outcomes. The trial is designed to provide valuable information on whether adding darolutamide can improve outcomes for patients with mCRPC. The study is expected to continue until 2030, with recruitment starting in 2025.

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 trial

    Upon joining the trial, you will be informed about the study's purpose, procedures, and your role as a participant. You will be asked to provide consent to participate in the trial.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting necessary tests to ensure you meet the criteria for participation.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive the medication darolutamide in addition to the standard care chosen by your physician. Darolutamide is administered orally in the form of film-coated tablets.

    The dosage and frequency of darolutamide will be determined by your healthcare provider based on the study protocol. You will be required to take the medication as prescribed for the duration of the trial.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring will be conducted to assess your response to the treatment. This includes scheduled visits for physical examinations, blood tests, and imaging studies to evaluate the progression of your condition.

    You will be asked to report any side effects or changes in your health to the study team promptly.

  5. Step 5

    Maintenance therapy

    After the initial treatment phase, you may continue to receive darolutamide as part of a maintenance therapy plan. This phase aims to maintain the benefits achieved during the initial treatment.

    The duration and specifics of the maintenance therapy will be determined by your healthcare provider in accordance with the study guidelines.

  6. Step 6

    End of trial

    At the end of the trial, a final assessment will be conducted to evaluate the overall outcomes of the treatment. This includes a comprehensive review of your health status and any changes observed during the study.

    You will receive information about the results of the trial and any further steps or recommendations for your ongoing care.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of prostate cancer, through a tissue sample test.
  • Must have castration-resistant prostate cancer, meaning the cancer continues to grow even when the amount of male hormones in the body is reduced to very low levels. This can happen after surgical removal of the testicles (orchiectomy) or during treatment with medications that lower hormone levels, known as GnRH analogues.
  • If not surgically castrated, must agree to continue using GnRH analogues, which are medications that lower male hormone levels, during the trial.
  • Must have metastatic disease, meaning the cancer has spread to other parts of the body, confirmed by imaging tests according to specific criteria (PCWG3 criteria).
  • Must have previously responded to a type of medication called ARPI (Androgen Receptor Pathway Inhibitors) for at least 12 months when the cancer was still sensitive to hormone therapy (mHSPC setting).
  • Must have adequate functioning of the bone marrow (which produces blood cells), liver (hepatic function), and kidneys (renal function).
  • Must be male.

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

Darolutamide is a medication used in this clinical trial to help treat a type of prostate cancer known as metastatic castration-resistant prostate cancer (mCRPC). This medication works by blocking the action of male hormones, like testosterone, which can help slow down the growth of cancer cells. In this trial, darolutamide is added to the standard treatment chosen by the doctor and is also used as a maintenance therapy. The goal is to see if it can help patients live longer without their cancer getting worse, as seen on medical imaging tests.

What is already known about the treatment

Darolutamide – Darolutamide is administered orally in the form of tablets and is currently being studied for its effectiveness in treating metastatic castration-resistant prostate cancer (mCRPC). It is used alongside standard care treatments chosen by physicians and then continued as a maintenance therapy. The main goal of using darolutamide is to improve the time patients live without their cancer worsening, known as radiographic progression-free survival. At the molecular level, darolutamide works by blocking the action of male hormones that can promote the growth of prostate cancer cells. It is classified as an androgen receptor inhibitor, which means it helps to prevent these hormones from fueling cancer growth.

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 effective in controlling the growth of prostate cancer. Over time, the cancer cells adapt and continue to proliferate even in the low-testosterone environment. This progression often leads to the spread of cancer to bones and other organs. The disease is characterized by an increase in prostate-specific antigen (PSA) levels, indicating cancer activity. As the cancer advances, patients may experience symptoms such as bone pain and urinary issues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512132-29-00Protocol codeSAKK 08/23Estimated enrolment162 patientsSponsorSwiss Group for Clinical Cancer Research

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