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Study on the Effectiveness of ADT with or without Darolutamide in Men with Newly Diagnosed Metastatic Prostate Cancer and Limited Functional Ability

Verified siteInvestigationalNo 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 cancer called prostate cancer, specifically in its advanced stage known as metastatic prostate cancer. This means the cancer has spread from the prostate to other parts of the body. The trial is investigating the effectiveness of a treatment that combines a standard therapy called Androgen Deprivation Therapy (ADT) with a medication named darolutamide, which is also known by its code name BAY 1841788. Darolutamide is a type of drug that blocks certain hormones that can promote cancer growth.

The purpose of the study is to compare the effects of ADT combined with darolutamide against ADT combined with a placebo in men who have not previously received certain other cancer treatments. Participants in the study will be randomly assigned to receive either the combination of ADT and darolutamide or ADT and a placebo. The study will monitor how the cancer progresses over time and assess the overall health and survival of the participants.

Throughout the study, participants will have regular check-ups and tests to track their health and the status of their cancer. The trial aims to provide valuable information on whether adding darolutamide to the standard treatment can help improve outcomes for patients with metastatic prostate cancer who have not been treated with other specific cancer drugs. This research is important for understanding new ways to manage and treat this type of cancer.

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 required to sign a written informed consent form. This document confirms your understanding of the trial and your agreement to participate.

    If you are sexually active, you must agree to use adequate contraception during the trial and for two weeks after completing the study treatment.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, medical history, and current health status.

    You must have a confirmed diagnosis of adenocarcinoma of the prostate and meet specific health criteria, such as adequate bone marrow, liver, and kidney function.

  3. Step 3

    Randomization

    You will be randomly assigned to one of two groups: one receiving ADT (androgen deprivation therapy) with darolutamide, and the other receiving ADT with a placebo.

    This process ensures that the study results are unbiased and reliable.

  4. Step 4

    Treatment phase

    If you are in the darolutamide group, you will take the medication in the form of a film-coated tablet, administered orally.

    The dosage and frequency of the medication will be determined by the study protocol and communicated to you by the study team.

  5. Step 5

    Regular monitoring

    Throughout the trial, you will have scheduled visits for monitoring your health and the effects of the treatment.

    These visits will include examinations and tests to assess your response to the treatment and any side effects.

  6. Step 6

    Follow-up

    After completing the treatment phase, follow-up visits will be scheduled to monitor your long-term health and any lasting effects of the treatment.

    These visits are crucial for evaluating the overall success and safety of the treatment.

Who can join the trial?

12 criteria

  • Signed a written informed consent form before any trial-specific procedures.
  • For sexually active men, agreement to use adequate contraception during the trial and for 2 weeks after completing the study treatment.
  • Affiliated with the social security system or have equivalent private health insurance, as required by local regulations for clinical trials.
  • Willing and able to follow the trial protocol, including undergoing treatment, attending scheduled visits, and having examinations, including follow-up.
  • Men with confirmed adenocarcinoma of the prostate (a type of prostate cancer).
  • Aged 18 years or older at the time of signing the informed consent.
  • De novo metastatic disease, meaning the cancer has spread to other parts of the body, confirmed by clinical or radiographic evidence.
  • Have measurable disease or bone lesions that can be evaluated according to specific criteria (PCWG3 criteria).
  • Ineligible for treatment with certain drugs: docetaxel, abiraterone, enzalutamide, apalutamide, and meet at least one frailty criterion.
  • Adequate bone marrow function: hemoglobin ≥ 80g/L, white blood cells ≥ 3.0 x109/L, and platelets ≥ 80 x109/L.
  • Adequate liver function: alanine aminotransferase (ALT) less than 2 times the upper limit of normal (ULN) and bilirubin less than 1.5 times ULN. If bilirubin is between 1.5-2 times ULN, normal conjugated bilirubin is required. For patients with liver metastasis, ALT less than 5 times ULN is acceptable.
  • Adequate renal function: calculated creatinine clearance greater than 30 ml/min, using specific methods (MDRD or CKD EPI method).

Who cannot join the trial?

5 criteria

  • Patients who have already received treatment with **docetaxel** or other **androgen receptor pathway inhibitors** cannot participate. Docetaxel is a type of chemotherapy drug, and androgen receptor pathway inhibitors are medications that block male hormones that can promote cancer growth.
  • Patients who are not **castration-naïve** are excluded. Castration-naïve means that the patient has not yet received treatment to lower testosterone levels, which is often used to slow the growth of prostate cancer.
  • Only male patients can participate, as the study is specific to prostate cancer.
  • Patients with a different type of cancer or medical condition other than **adenocarcinoma of the prostate** are not eligible. Adenocarcinoma of the prostate is a specific type of prostate cancer.
  • Patients who are considered part of a **vulnerable population** are not eligible. A vulnerable population includes individuals who may have limited ability to give informed consent or are at higher risk of being harmed by the study.
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Investigated drugs

  • ADT

    stands for Androgen Deprivation Therapy. It 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. ADT is often used in treating prostate cancer, especially when the cancer has spread to other parts of the body.

  • Darolutamide

    is a medication used to treat prostate cancer. It works by blocking the action of male hormones that can promote the growth of cancer cells. By doing this, darolutamide helps to slow down or stop the progression of the cancer. It is often used in combination with other treatments like ADT to improve outcomes for patients with prostate cancer.

What is already known about the treatment

Darolutamide – Darolutamide is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating prostate cancer, specifically adenocarcinoma of the prostate. It is used in combination with androgen deprivation therapy (ADT) to help manage prostate cancer in patients who have not previously received certain other treatments. 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, which means it helps prevent cancer cells from receiving signals that tell them to grow.

Investigated diseases

Adenocarcinoma of the prostate – Adenocarcinoma of the prostate is a type of cancer that begins in the gland cells of the prostate, which is a small gland in men that produces seminal fluid. This disease typically progresses slowly and may not show symptoms in its early stages. As it advances, it can lead to difficulties with urination, blood in the urine, or pelvic discomfort. The cancer can spread to nearby tissues or other parts of the body, such as the bones and lymph nodes. The progression of the disease is often monitored through imaging and other tests to assess the spread and growth of the cancer. The rate of progression can vary significantly among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502425-18-00Protocol codeUC-GTG-2006Estimated enrolment308 patientsSponsorUnicancer

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