Testing ADT with or without darolutamide in prostate cancer patients

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    What is this study about?

    This study is about testing how well two different kinds of prostate cancer treatment work. One treatment is called ADT (Androgen deprivation therapy) and the other is called darolutamide. In total, around 300 men who have just been diagnosed with prostate cancer will take part. The people in the study will be split into two groups. Half of the people will have the ADT treatment with placebo, while the other half will have both the ADT and darolutamide treatment. This will help the researchers understand whether adding darolutamide makes the ADT treatment work better. To check how well the treatment is working, the researchers will be using different methods.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Charleroi , Belgium

      Haine-Saint-Paul , Belgium

      Namur , Belgium

      Ottignies , Belgium

      Avignon , France

      Bayonne , France

      Besanu00e7on , France

      Bordeaux , France

      Brest , France

      Caen , France

      Chambu00e9ry , France

      Clermont-Ferrand , France

      Cru00e9teil , France

      Dijon , France

      Grenoble , France

      La Roche-sur-Yon , France

      Le Mans , France

      Lille , France

      Limoges , France

      Lorient , France

      Lyon , France

      Marseille , France

      Mougins , France

      Nice , France

      Nu00eemes , France

      Paris , France

      Paris , France

      Paris , France

      Paris , France

      Paris , France

      Pierre-Bu00e9nite , France

      Poitiers , France

      Pringy , France

      Quimper , France

      Reims , France

      Rennes , France

      Rodez , France

      Saint Gru00e9goire , France

      Saint Mandu00e9 , France

      Saint-u00c9tienne , France

      Saint-u00c9tienne , France

      Strasbourg , France

      Strasbourg , France

      Suresnes , France

      Toulon , France

      Toulouse , France

      Toulouse , France

      Tours , France

      Vandu0153uvre-lu00e8s-Nancy , France

      Villejuif , France

      Badalona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Girona , Spain

      Madrid , Spain

      Madrid , Spain

      Manresa , Spain

      Valencia , Spain


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps a patient needs to take in this clinical trial are as follows:

      1. Enrollment in the trial, where a patient will be randomized in a 1:1 ratio to receive either:
        1. Experimental arm: ADT (Androgen Deprivation Therapy) plus darolutamide at a dosage of 600 mg taken orally twice daily (po bid).
        2. Control arm: ADT plus placebo taken orally twice daily (po bid).
      2. Regular assessment of the response to treatment according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.
      3. Continuation of treatment until there is radiographic disease progression.
      4. Treatment may also be terminated early at the initiative of either the patient or the investigator for reasons beneficial to the patient, such as unacceptable toxicity, conditions that preclude the continuation of treatment, or patient request.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have adenocarcinoma of the prostate with newly diagnosed metastatic disease, as confirmed by clinical or radiological evidence.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Below is a list of the inclusion criteria for the clinical trial, with explanations of medical terms where necessary:

      1. Signed Informed Consent: You must sign a written informed consent form before any trial-specific procedures.
      2. Diagnosis: You must be a man with histologically or cytologically confirmed adenocarcinoma of the prostate. This means that your prostate cancer must be confirmed through tissue analysis.
      3. Age: You must be aged 18 years or older at the time of signing informed consent.
      4. Metastatic Disease: You must have de novo metastatic disease, which means you have new evidence of metastases (spread of cancer from the primary site to other parts of the body) either clinically or through imaging.
      5. Measurable Disease: You should have a measurable disease or bone lesions that can be evaluated according to PCWG3 criteria. The PCWG3 criteria are a set of guidelines for evaluating the response of prostate cancer to treatment, especially considering bone lesions which are common in prostate cancer.
      6. Drug Ineligibility and Frailty: You must be ineligible for treatment with certain drugs such as docetaxel, abiraterone, enzalutamide, apalutamide; and meet at least one frailty criteria, which include:
        1. Activities of daily living (ADL) assessment score 3 or 4/5; which measures your ability to perform everyday tasks independently.
        2. Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4; which measures your ability to perform complex activities required for independent living.
        3. A Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire; which is a tool for evaluating the health status of older adults by scoring the severity of comorbidities.
        4. Body mass index (BMI) less than or equal to 21 kg/m² and/or more than 10% weight loss in the last 6 months.
        5. Timed up and go test (TUG) greater than 14 seconds; this test measures the time it takes for a person to stand up from a chair, walk three meters, turn around, walk back, and sit down.
      7. Bone Marrow Function: Your haemoglobin must be greater than or equal to 80 g/L, white blood cells greater than or equal to 3.0 x10^9/L, and platelets greater than or equal to 80 x10^9/L; indicating adequate bone marrow function to produce blood cells.
      8. Liver Function: Your alanine aminotransferase (ALT) must be less than 2 times the upper limit of normal (ULN) and bilirubin less than 1.5 times ULN. If you have documented liver metastasis, ALT less than 5 times ULN is acceptable.
      9. Renal Function: Calculated creatinine clearance must be sufficient, indicating your kidneys are functioning well enough to filter waste products from the blood.
      10. Compliance: No known psychological, familial, sociological or geographical condition can be present that would potentially hamper compliance with the study protocol and follow-up schedule.

      Please note that if any of the terms are still unclear or require further elaboration, feel free to ask for more details.

      What Reasons Could Exclude Me from the Study?

      You cannot take part in the study if you meet any of the following Exclusion Criteria:

      1. Three or more Grade 3, or any Grade 4 events on the CISR-G questionnaire: This refers to a questionnaire used to assess the severity of several diseases in geriatrics. Grade 3 and Grade 4 events indicate more severe health problems.
      2. Eastern Cooperative Oncology Group (ECOG) performance status score ≥3: This score reflects a patient’s level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. Scores range from 0 to 5, with a higher score indicating greater disability.
      3. Uncontrolled hypertension: Having high blood pressure that is not managed effectively with medication, specifically a systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg.
      4. Acute toxicities of prior treatments not resolved to grade ≤1 or baseline: This means recent side effects from previous medical treatments must be mild (grade 1) or resolved to the level before treatment (baseline), except for hot flushes and erectile dysfunction.
      5. Previous systemic treatment for prostate cancer: You’re excluded if you’ve had certain treatments for prostate cancer, with limited exceptions.
      6. Severe or uncontrolled concurrent disease, infection, or comorbidity: This includes having serious or not well-managed additional diseases or infections alongside prostate cancer.
      7. Known hypersensitivity to the study treatment or ingredients: You must not be allergic to any components of the study medication.
      8. Major surgery within 28 days before randomisation: Recent significant surgical procedures could exclude you from the study.
      9. Stroke, myocardial infarction, severe/unstable angina pectoris, etc., within 6 months before randomisation: Recent serious cardiovascular events may lead to exclusion.
      10. Prior malignancy within 3 years before study enrolment: With certain exceptions for specific types of cancer, having another cancer in the last three years could exclude you.
      11. Inability to swallow oral medications: As the study medication may be in pill form, you need to be able to take oral medication.
      12. Significant gastrointestinal disorder or procedure: Any condition or procedure that affects the digestive system and could interfere with the medication’s absorption is a reason for exclusion.
      13. Active viral hepatitis, HIV, or chronic liver disease: These conditions can affect your eligibility to participate.
      14. Treatment with investigational product within 28 days: Participation in another clinical study using an investigational product shortly before this study can exclude you.
      15. Concurrent participation in another clinical trial: You can’t be in another clinical trial that involves an investigational product.
      16. Deprived of liberty or under the authority of a tutor: If you are legally not permitted to make decisions for yourself, you cannot participate.
      17. Significantly altered mental status: This means if you have a mental condition that prevents you from understanding the study and giving informed consent, you cannot participate.

      These criteria are in place to ensure the safety of participants and the validity of the study results.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical trial involves the following drugs:

      1. Darolutamide (Nubeqa®): Darolutamide is a non-steroidal anti-androgen (NSAA) medication which is used to treat prostate cancer. It works by blocking the action of androgens like testosterone on the prostate, which can help to slow the growth of prostate cancer cells.
      2. Androgen Deprivation Therapy (ADT): While not a single drug, ADT is a treatment used to reduce the levels of androgens in the body. This can be accomplished through medications or surgical procedures and is also known as hormonal therapy. Its use in prostate cancer is to slow or stop the growth of cancer cells by depriving them of androgens.
      3. Placebo: A placebo is a substance with no therapeutic effect that is used as a control in testing new drugs. It helps to measure the effect of the drug being tested by comparing outcomes with those participants not receiving the active substance.

      This list includes both the trade name of the drug and the name of the active substance and a brief description.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial involves the following active substances:

      1. Darolutamide: Yes, Darolutamide is already known to medicine and the medical literature. It is a non-steroidal androgen receptor antagonist used for the treatment of prostate cancer and is commercially available under the name Nubeqa®. The dosage used in this clinical trial is 600 mg orally twice a day (po b.i.d.).
      2. Androgen Deprivation Therapy (ADT): ADT is a standard treatment for prostate cancer that involves reducing androgen levels to prevent them from stimulating the growth of prostate cancer cells. Substances used in ADT could include but are not limited to drugs like leuprolide or goserelin, which are well-established in medical practice
      3. Placebo: A placebo is an inactive substance commonly used in clinical trials as a control to test the efficacy of the active drug, which in this case is Darolutamide.

      Study ID

      CT-EU-00067957

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      III

      Diseases