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Study Comparing Docetaxel, Darolutamide, and ADT for Patients with Metastatic Hormone-Sensitive 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-sensitive prostate cancer, a type of cancer that has spread beyond the prostate gland but still responds to hormone therapy. The study involves comparing two different dosing schedules of a chemotherapy drug called docetaxel. One group of patients will receive docetaxel at a dose of 75 mg per square meter of body surface area every three weeks, while another group will receive 50 mg per square meter every two weeks. Both groups will also receive a medication called darolutamide and a type of hormone therapy known as androgen deprivation therapy (ADT), which reduces levels of male hormones that can promote cancer growth.

The purpose of the study is to compare the safety of these treatment regimens by looking at the occurrence of serious side effects. The study will also monitor for a specific side effect called neutropenia, which is a low level of white blood cells that can increase the risk of infection. Patients will undergo six cycles of treatment, and the study will track their health and any side effects they experience during this time. The trial will also assess other outcomes, such as overall survival, the time it takes for the cancer to become resistant to hormone therapy, and the quality of life of the participants.

Participants in the study will receive their treatments either as an intravenous infusion, which is a method of delivering medication directly into the bloodstream, or as oral tablets. The study aims to provide valuable information on the best way to use docetaxel in combination with darolutamide and ADT for treating this type of prostate cancer. The results could help improve treatment strategies and outcomes for patients with this condition.

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 trial

    Upon joining the trial, consent is required. This involves understanding the trial's purpose, procedures, and potential risks and benefits.

    Eligibility is confirmed through specific criteria, including age, medical history, and current health status.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline health information. This may include blood tests, imaging scans, and other diagnostic procedures.

    The assessment helps determine the current state of the prostate cancer and ensures all criteria for participation are met.

  3. Step 3

    Treatment phase

    The treatment phase involves receiving medications. Docetaxel is administered either every 3 weeks at 75 mg/m² or every 2 weeks at 50 mg/m², depending on the assigned group.

    Darolutamide is taken orally as part of the treatment regimen. The dosage and frequency are determined by the study protocol.

    Additional medications, such as ADT (androgen deprivation therapy), may be part of the treatment plan.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and manage any side effects. This includes blood tests, imaging, and other evaluations.

    Follow-up visits are scheduled to track progress and make any necessary adjustments to the treatment plan.

  5. Step 5

    End of treatment

    At the end of the treatment phase, a final assessment is conducted to evaluate the overall response to the therapy.

    Long-term follow-up may be required to monitor health status and any delayed effects of the treatment.

Who can join the trial?

11 criteria

  • Must provide written informed consent, which means you agree to participate in the study after being informed about all aspects of the trial.
  • Blood tests must show certain levels: serum alanine aminotransferase and/or aspartate transaminase should be no more than 1.5 times the normal limit, total bilirubin should be within the normal limit, and creatinine should be no more than 2 times the normal limit.
  • If sexually active, male participants must agree to use condoms and not donate sperm during the study and for a period after the study. Female partners should use effective birth control during this time.
  • Must be a male aged 18 years or older.
  • Must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of prostate cancer.
  • Must have metastatic disease, meaning the cancer has spread to other parts of the body, confirmed by specific scans like a bone scan, CT, or MRI.
  • Participants with only lymph node metastases in certain areas will not be eligible.
  • Must be suitable for treatment with ADT (Androgen Deprivation Therapy), docetaxel, and darolutamide as judged by the study doctor.
  • Must have started ADT treatment no more than 12 weeks before joining the study. If using LHRH agonists, it is recommended to have used them with a first-generation anti-androgen for at least 4 weeks before joining, but the anti-androgen must be stopped before joining.
  • Must have an Eastern Cooperative Oncology Group performance status of 0 or 1, which indicates you are fully active or have some symptoms but do not require bed rest.
  • Blood counts must meet certain levels: hemoglobin of at least 9.0 g/dL, absolute neutrophil count of at least 1.5x109/L, and platelet count of at least 100x109/L. You must not have received any growth factor treatment within 4 weeks or a blood transfusion within 7 days before the blood test.

Who cannot join the trial?

3 criteria

  • Patients who do not have prostate cancer cannot participate.
  • Only male patients are eligible for the study.
  • Patients who are part of a vulnerable population are not eligible. This means groups that might need special protection, like children or people who cannot make decisions for themselves.
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Investigated drugs

  • Docetaxel

    is a type of chemotherapy medication used in this trial to treat prostate cancer. It works by stopping cancer cells from growing and dividing, which can help slow down or stop the spread of the disease. In this study, Docetaxel is given to patients in different schedules to see which one is more effective and has fewer side effects.

  • 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 used in combination with other treatments to help manage the disease and improve patient outcomes.

  • ADT

    , or Androgen Deprivation Therapy, is a treatment that reduces the levels of male hormones in the body. These hormones can help prostate cancer cells grow, so lowering their levels can slow down the progression of the disease. ADT is often used alongside other treatments to enhance their effectiveness.

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 drip. It is currently used in medicine to treat various types of cancer, including prostate cancer, and is well-documented in medical literature. The main therapeutic indication for Docetaxel in this trial is metastatic hormone-sensitive prostate cancer (mHSPC). At the molecular level, Docetaxel works by interfering with the normal function of microtubules, which are structures that help cells divide, thereby preventing cancer cells from multiplying. It is classified as a chemotherapy drug, specifically a taxane.

  • Darolutamide

    Darolutamide is taken orally in the form of tablets. It is an approved medication used in the treatment of prostate cancer and is supported by extensive medical research. In this trial, it is used for patients with metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide works by blocking the action of male hormones, like testosterone, which can promote the growth of cancer cells. It is classified as an androgen receptor inhibitor.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often begins with small changes in the size and shape of prostate cells, which can develop into a tumor. As the disease progresses, it may spread to nearby tissues or other parts of the body, such as the bones or lymph nodes. The progression can lead to symptoms like difficulty urinating, blood in the urine, or pelvic discomfort. Over time, prostate cancer can become resistant to hormonal therapy, a stage known as castration-resistant prostate cancer. The disease's progression is monitored through various markers, including prostate-specific antigen (PSA) levels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502634-52-00Protocol codeUTN-01-2022Estimated enrolment280 patientsSponsorFriedrich-Schiller-Universitaet Jena

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