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Study on Surgery with or without Darolutamide for Patients with High-Risk or Locally Advanced Prostate Cancer

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 high-risk and/or locally advanced prostate cancer. The treatment being tested is a medication called darolutamide, which is taken as a film-coated tablet. The purpose of the study is to determine if taking darolutamide before and after surgery can improve outcomes for patients compared to having surgery alone.

Participants in the study will be randomly assigned to one of two groups. One group will receive surgery along with darolutamide, while the other group will have surgery without the medication. The study will last for up to nine months, during which time participants will take the medication and attend scheduled visits and examinations. The study will monitor the progression of the cancer and assess the overall health and quality of life of the participants.

The trial aims to see if darolutamide can help prevent the cancer from becoming non-curable. It will also look at other factors such as the time it takes for the cancer to spread to other parts of the body, the time until a rise in prostate-specific antigen (PSA) levels, and overall survival rates. Safety and quality of life will also be evaluated using various questionnaires. Participants will be closely monitored throughout the study to ensure their well-being.

The research process

The trial runs in 7 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 provide a signed informed consent. This document confirms your understanding of the study and your willingness to participate.

    You must meet certain criteria, such as being at least 18 years old, having a confirmed diagnosis of high-risk and/or locally advanced prostate cancer, and being eligible for surgery.

  2. Step 2

    Initial assessments

    Before starting the treatment, you will undergo various assessments to ensure you meet all the necessary health requirements. These assessments include blood tests to check organ function and imaging tests to confirm the absence of distant metastasis.

    Your ability to swallow tablets and your overall health status will also be evaluated.

  3. Step 3

    Treatment with darolutamide

    If you are selected for the treatment group, you will receive a medication called darolutamide. This medication is provided in the form of film-coated tablets and is taken orally.

    You will take the medication for up to 9 months, as determined by the study investigator. The exact dosage and frequency will be explained to you by the study team.

  4. Step 4

    Surgery

    You will undergo surgery as part of the study. The timing of the surgery will be coordinated with your treatment schedule.

    The goal of the surgery is to remove the prostate cancer, and it will be performed by a qualified medical professional.

  5. Step 5

    Post-surgery treatment

    After surgery, you may continue to receive darolutamide treatment for a specified period, as part of the study protocol.

    Regular follow-up visits will be scheduled to monitor your recovery and assess the effectiveness of the treatment.

  6. Step 6

    Follow-up and assessments

    Throughout the study, you will have scheduled visits for follow-up assessments. These visits will include physical examinations, blood tests, and imaging tests to monitor your health and the status of the cancer.

    Your quality of life will also be evaluated using specific questionnaires designed to assess your well-being and any symptoms you may experience.

  7. Step 7

    Completion of the study

    At the end of the study period, a final assessment will be conducted to evaluate the overall outcomes of the treatment.

    You will be informed about the results and any further steps that may be necessary for your health care.

Who can join the trial?

13 criteria

  • Must be a man aged 18 years or older.
  • Must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of prostate cancer.
  • Must have high-risk and/or locally advanced prostate cancer. This can be determined by specific medical criteria such as certain grades on biopsies, specific findings on MRI or PET-Scan, or high PSA levels.
  • Must not have distant metastasis, meaning the cancer has not spread to other parts of the body, confirmed by imaging tests like MRI, CT-Scan, or PET-Scan.
  • Must have an ECOG Performance Status score of 0-1, which means the patient is fully active or has some symptoms but does not require bed rest.
  • Must be eligible for radical prostatectomy, which is a type of surgery to remove the prostate, as determined by the study doctor.
  • Must have adequate organ function, which will be checked by specific blood tests to ensure the liver, kidneys, and other organs are working well.
  • Must be able to receive the study drug darolutamide for up to 9 months, as determined by the study doctor.
  • Must be able to swallow whole tablets of the study drug.
  • Must have a life expectancy of more than 5 years.
  • If sexually active with a woman who can become pregnant, must agree to use highly effective contraception during the study and for at least one week after the study drug ends.
  • Must provide signed informed consent, which means agreeing to participate in the study after being fully informed about it.
  • Must be willing to follow the study rules, including attending scheduled visits and undergoing necessary tests and treatments.

Who cannot join the trial?

3 criteria

  • Patients who do not have high-risk or locally advanced prostate cancer cannot participate.
  • Only male patients are eligible for this study.
  • Patients who are part of a vulnerable population are not eligible. This means people who might be at a higher risk of harm or exploitation.
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Investigated drugs

Darolutamide is a medication used in this clinical trial to treat prostate cancer. It works by blocking the action of male hormones, like testosterone, which can help slow down or stop the growth of cancer cells. In this study, darolutamide is given to patients before and after surgery to see if it can improve the chances of staying cancer-free compared to having surgery alone. The goal is to find out if using darolutamide can help prevent the cancer from coming back or spreading to other parts of the body.

What is already known about the treatment

Darolutamide – Darolutamide is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating high-risk and/or locally advanced prostate cancer. The main therapeutic indication for darolutamide is to improve progression-free survival in patients undergoing surgery for prostate cancer. At the molecular level, darolutamide works by blocking the action of male hormones, such as testosterone, which can promote the growth of prostate cancer cells. It is classified as an androgen receptor inhibitor, which means it helps to prevent cancer cells from receiving the signals they need to grow.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can lead to difficulties in urination, blood in urine, or pelvic discomfort. In more severe cases, it can spread to nearby tissues or distant parts of the body, such as bones and lymph nodes. The progression can vary, with some cases remaining localized while others become more aggressive. Monitoring and regular assessments are crucial to understanding its development.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501518-67-00Protocol code22GENH03Estimated enrolment240 patientsSponsorOncopole Claudius Regaud

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