Study of combination therapy for Prostate Cancer treatment

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    What is this study about?

    This study focuses on testing a new treatment approach for medium-high risk prostate cancer. The therapy, called darolutamide, will be administered with radiation therapy to evaluate its efficacy in destroying cancer cells more effectively. The trial is divided into two ‘arms’: one arm involves patients receiving darolutamide alongside radiation therapy for six months, while the other arm involves patients receiving a different form of therapy (androgen deprivation therapy) along with the same radiation therapy. By comparing the effects of these two treatments, doctors aim to determine which one is more effective against prostate cancer. PSA levels are also used by researchers to assess treatment response in patients.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Avignon , France

      Besanu00e7on , France

      Bordeaux , France

      Brest , France

      Marseille , France

      Paris , France

      Saint-Gru00e9goire , France

      Saint-Herblain , France

      Toulouse , France

      Toulouse , France

      You can join this study in:

      Study Steps

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

      In this clinical trial, patients who meet the eligibility criteria will be randomized into one of two treatment modalities:

      • Arm A (Experimental Arm): Patients will be treated with a combination of External Beam Radiotherapy (EBRT) and darolutamide for a total duration of 6 months. Specifically, darolutamide will be administered orally at a fixed dose of 600 mg twice daily (a total of 1200 mg daily), on a continuous basis, starting from Day 1. The EBRT will begin two months after the initiation of treatment with darolutamide. The EBRT treatment will follow standard schedules, which include either 78 Gy in classical 2 Gy/fractions, conducted five days a week, or 60 Gy in 3 Gy/fractions, also five days a week. The use of Intensity-Modulated Radiotherapy (IMRT) and Image-Guided Radiotherapy (IGRT) is mandatory[10†source].
      • Arm B (Standard Arm): Patients will be treated with a combination of External Beam Radiotherapy (EBRT) and Androgen Deprivation Therapy (ADT) also for a duration of 6 months. The ADT will be prescribed based on market authorization and the judgment of the investigator and may consist of either Luteinizing Hormone-Releasing Hormone (LH-RH) agonist injections given every 3 months for 6 months or a once-for-6-months regimen, or monthly LH-RH antagonist administration for 6 months. Similar to Arm A, the EBRT will commence two months after treatment initiation and will follow similar dosing and scheduling protocols as described in Arm A. The Clinical Target Volume Definition will be in accordance with GETUG Guidelines, and organ at risk dose constraints will adhere to RECORAD standards[11†source].

      It’s important to note that in this trial, two patients will be randomized into the Experimental Arm A for every one patient randomized into the Standard Arm B[9†source].


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have prostate cancer, specifically with an unfavorable intermediate risk profile【9†source】.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here is a list of the inclusion criteria for the clinical trial, along with explanations for any medical terms:

      1. Age ≥ 18: You must be at least 18 years old to participate.
      2. Histological diagnosis of prostate malignancy cancer: Your prostate cancer must be confirmed by examining tissue under a microscope.
      3. Cancer without loco-regional or distant metastasis: The cancer should not have spread locally within the prostate region or to distant parts of the body. Assessment includes Pelvic MRI, thoraco-abdomino-pelvic contrast-enhanced CT-Scan, and Bone Scintigraphy. PET-Scan may also be used based on the investigator’s judgement.
      4. Unfavorable intermediate risk prostate cancer diagnosis: Your prostate cancer should meet specific criteria defined by the NCCN Guidelines, such as a Gleason score of 7 (4+3), or more than 50% of biopsy cores positive for adenocarcinoma. Other combinations of criteria can also define this risk category, such as a PSA value between 10-20 ng/ml, Gleason score of 7 (3+4) or 6, or T2b clinical or radiological stage. (The Gleason score is a grading system that evaluates the aggressiveness of prostate cancer based on microscopic appearance, while PSA is a protein produced by the prostate and the level is measured to monitor prostate cancer).
      5. Prior low-risk prostate cancer patients eligible if conditions are met: If previously diagnosed with low risk prostate cancer, you must have progressed to eligible risk disease according to the protocol within 30 days before registration.
      6. Life expectancy of at least 5 years: You are expected to live at least five more years.
      7. Performance status ECOG ≤ 2: This refers to the Eastern Cooperative Oncology Group (ECOG) Performance Status, which measures how cancer affects your daily living abilities. A score of 2 indicates you can move about and are capable of all self-care but cannot carry out work activities.
      8. No contraindications to EBRT: You should not have any medical reasons that would prevent you from receiving external beam radiation therapy (EBRT) as judged by a physician.
      9. Adequate organ function as defined by specific laboratory values: Laboratory tests must show that your organs are functioning properly.
      10. Availability of archived paraffin-embedded tumor sample: There must be a stored tissue sample of your tumor for research purposes.
      11. Compliance with French social security laws: You must have social security in accordance with French law.
      12. Voluntary consent: You agree to participate in the study and understand the procedures after signing a written consent form.
      13. Agreement to use effective contraception: If you are of reproductive potential, you must agree to use an effective method of contraception throughout the treatment period and for one week after.

      Please note, these criteria are specific to this trial and understanding the medical terms will help you assess your eligibility【9†source】.

      What Reasons Could Exclude Me from the Study?

      Certainly, here is a list of conditions under which you cannot take part in the study, with explanations of the medical terms provided where necessary:

      1. Uncontrolled hypertension: This means high blood pressure that isn’t being managed or controlled through treatment.
      2. Impairment of gastrointestinal function or GI disease: Any dysfunction or disease of the stomach and intestines that might affect how the study drug is absorbed into your body.
      3. Major surgery within 4 weeks prior enrolment: If you’ve had a significant surgical procedure within one month before the study starts, you can’t join, except for pelvic lymph-nodes dissection.
      4. Known hypersensitivity: An allergic reaction to any of the drugs being used in the study or to their formulation components, to natural gonadotropin-releasing hormone, or its analogues.
      5. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome: These are different conditions where your body can’t properly digest certain sugars, which could interfere with the study or its medication.
      6. Men not using an effective method of contraception: Men who are not using birth control methods as described in the study guidelines cannot participate.
      7. Use of herbal or alternative remedies that may affect hormonal status: If you’re taking supplements or remedies like Prostasol or PC-SPES that can change your hormone levels, you’re not eligible for the study.
      8. History of non-compliance to medical regimens or inability to grant consent: If you have a history of not following medical advice or treatment plans, or if you are not able to legally consent to participate, you cannot join the study.
      9. Unable to follow and comply with study procedures: If you can’t adhere to the study’s requirements due to geographical, social, or psychological reasons, you won’t be able to participate.
      10. Individuals under judicial protection or deprived of liberty: If you are under some form of judicial protection or imprisonment, you are not eligible for the study.

      Please be aware that this is not an exhaustive list and that there may be other factors that could disqualify you from participating in the study. It’s important to talk to the study’s healthcare team for a full understanding of the eligibility criteria【11†source】.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical trial involves the following drugs:

      1. Darolutamide: Darolutamide is used in experimental Arm A of the trial. It is an oral androgen receptor inhibitor used in the treatment of prostate cancer. The medication is taken at a fixed dose of 600 mg twice daily (1200 mg in total) for a maximum of 6 months, beginning on Day 1. Darolutamide is combined with external beam radiotherapy (EBRT) for patients with unfavorable intermediate risk prostate cancer【9†source】.
      2. Androgen Deprivation Therapy (ADT): ADT is used in the standard Arm B of the trial. This therapy involves the use of medications or surgery to reduce the levels of androgens (male hormones) to prevent them from affecting prostate cancer cells. In this trial, ADT will be prescribed as per market authorization and following investigator judgment. The treatment could consist of either LH-RH agonist injection given every 3 months for 6 months or once for 6 months, or an LH-RH antagonist given monthly for 6 months, combined with external beam radiotherapy (EBRT). The specific substances used for ADT are not detailed in the provided document, as ADT is a general term for treatments that lower androgen levels【9†source】.

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

      The active substances participating in the clinical trial are known to medicine and the medical literature. Here is the list of substances involved in the trial, along with the respective description:

      1. Darolutamide

        Darolutamide is a substance used in Arm A (experimental arm) of the clinical trial. It is being evaluated for antitumor activity in combination with external beam radiotherapy (EBRT), specifically for patients with unfavorable intermediate risk prostate cancer. Patients in this arm will be treated with darolutamide for a maximum of 6 months combined with EBRT【9†source】.

      2. Androgen Deprivation Therapy (ADT)

        Androgen Deprivation Therapy is the substance used in Arm B (standard arm) of the clinical trial. It is the standard treatment evaluated in combination with EBRT for patients with unfavorable intermediate risk prostate cancer. ADT will be prescribed as per market authorization and following investigator judgment, and will last for 6 months combined with EBRT【9†source】.

      It should be noted that both darolutamide and the components of ADT (such as Luteinizing Hormone-Releasing Hormone agonists or antagonists – not specified by name) are established treatments that are known within the medical literature.


      Study ID

      CT-EU-00088977

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago

      Study phase

      Phase
      II

      Medicinal Product

      Diseases