Comparing darolutamide with standard therapy in hormone sensitive prostate cancer

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    What is this study about?

    This study explores a combination therapy using darolutamide and androgen deprivation therapy (ADT) for men with high-risk biochemical recurrence of prostate cancer. ADT are treatments that block androgens production in the body. The trial aims to determine if this combination prolongs the time without cancer worsening or leading to death compared to ADT alone. Participants will be randomly assigned to receive either the combination treatment or a placebo with ADT for 24 months. The study will track cancer progression, overall health, and any side effects, offering potential advancements in prostate cancer treatment.

    Learn more about this Trial

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      Where does the clinical trial take place?

      Linz , Austria

      Innsbruck , Austria

      Salzburg , Austria

      Wien , Austria

      Wien , Austria

      Bruxelles , Belgium

      Gent , Belgium

      Gent , Belgium

      Hasselt , Belgium

      Kortrijk , Belgium

      Leuven , Belgium

      Brno , Czechia

      Aalborg , Denmark

      Aarhus N , Denmark

      Copenhagen , Denmark

      Helsinki , Finland

      Oulu , Finland

      Tampere , Finland

      Turku , Finland

      Bordeaux , France

      Clermont-ferrand , France

      Grenoble , France

      Lille , France

      PARIS cedex 5 , France

      Paris , France

      Pierre Benite , France

      Reims , France

      Rennes Cedex , France

      Saint-cloud , France

      Saint-Herblain , France

      Strasbourg , France

      Tours , France

      Villejuif Cedex , France

      Mannheim , Germany

      Nu00fcrtingen , Germany

      Mu00fcnchen , Germany

      Wu00fcrzburg , Germany

      Frankfurt , Germany

      Gu00f6ttingen , Germany

      Ku00f6ln , Germany

      Mu00fcnster , Germany

      Magdeburg , Germany

      Dresden , Germany

      Bergisch Gladbach , Germany

      Berlin , Germany

      Jena , Germany

      Napoli , Italy

      Bologna , Italy

      Bologna , Italy

      Modena , Italy

      Reggio Emilia , Italy

      Pordenone , Italy

      Roma , Italy

      Roma , Italy

      Roma , Italy

      Bergamo , Italy

      Milano , Italy

      Milano , Italy

      Milano , Italy

      Torino , Italy

      Bari , Italy

      Foggia , Italy

      Padova , Italy

      Verona , Italy

      Genova , Italy

      Perugia , Italy

      Trento , Italy

      Dordrecht , Netherlands

      Eindhoven , Netherlands

      Groningen , Netherlands

      Hilversum , Netherlands

      Nieuwegein , Netherlands

      Rotterdam , Netherlands

      The Hague , Netherlands

      Kielce , Poland

      Lisboa , Portugal

      Lisboa , Portugal

      Lisboa , Portugal

      Lisboa , Portugal

      Santiago de Compostela , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Cadiz , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Murcia , Spain

      Mu00e1laga , Spain

      Sevilla , Spain

      Valencia , Spain

      Valencia , Spain

      Gothenburg , Sweden

      Malmo , Sweden

      Bedford , United Kingdom

      Northwood , United Kingdom

      Guildford , United Kingdom

      London , United Kingdom

      London , United Kingdom

      London , United Kingdom

      Study Steps

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

      I apologize for the inconvenience, but it seems that I have not been able to find the specific patient steps or procedures within the clinical trial document provided. There could be multiple reasons for this, including the document structure or the information not being explicitly listed under a searchable term.

      If you have more information or can provide further guidance on what to search for, I’ll be happy to help you further. Otherwise, the patient steps for a clinical trial usually include specific procedures such as screenings, taking medications or treatments as prescribed, regular check-ups and assessments, and following up after the trial. These general steps can vary significantly depending on the specific protocol of the trial.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have histologically or cytologically confirmed adenocarcinoma of the prostate. This includes prostate cancer that has been initially treated by any of the following:

      1. Radical prostatectomy (RP) followed by adjuvant radiotherapy (ART)
      2. Salvage radiotherapy (SRT)
      3. Radical prostatectomy (RP) in participants who are unfit for, or refused, ART or SRT

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria for the Study:

      1. Signed Informed Consent: You must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
      2. Age: You should be a male and 18 years of age or older at the time of signing the informed consent.
      3. Diagnosis: You must have a histologically or cytologically confirmed adenocarcinoma of the prostate. Adenocarcinoma is a type of cancer that forms in glandular tissues, which are a part of many organs, including the prostate.
      4. Initial Treatment: Your prostate cancer should initially have been treated by one of the following:
        • Radical prostatectomy (RP) – a surgical procedure to remove the entire prostate gland and some surrounding tissue.
        • Adjuvant radiotherapy (ART) – additional radiation therapy given after surgery.
        • Salvage radiotherapy (SRT) – radiation therapy given after surgery if PSA levels rise, indicating possible remaining cancer cells.
        • Primary radiotherapy (RT) – the first and main treatment for prostate cancer with radiation.
      5. High-risk Biochemical Recurrence (BCR): Defined as Prostate-specific antigen (PSA) doubling time (PSADT) of less than 12 months. PSADT is a calculation used to measure how quickly PSA levels in the blood double. Also, PSA must be 0.2 ng/mL or higher after ART or SRT post RP or after RP if you are unfit for ART or SRT, or PSA at least 2 ng/mL above its lowest level (nadir) after primary RT only.
      6. PSMA PET/CT Scan: You must undergo a prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) scan within 42 days before starting the study, using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11. This scan identifies prostate cancer lesions and is assessed by a blinded independent central review (BICR).
      7. Serum Testosterone Level: Your serum testosterone level must be at least 150 ng/dL (5.2 nmol/L).
      8. Eastern Cooperative Oncology Group (ECOG) Performance Status: A 0 or 1 score on the ECOG scale, which assesses the daily living abilities of cancer patients. A score of 0 indicates fully active, able to carry on all pre-disease activities without restriction, while a score of 1 indicates some symptoms but nearly fully ambulatory and able to carry out light work.
      9. Blood Counts: At screening, the following blood counts are required:
        • Hemoglobin at least 9.0 g/dL.
        • Absolute neutrophil count (ANC) at least 1.5×10^9/L.
        • Platelet count at least 100×10^9/L.

        Additionally, you should not have received a blood transfusion within 7 days or any growth factor within 4 weeks before the blood sample is taken.

      10. Liver and Kidney Function Tests: Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) levels should be within 1.5 times the upper limit of normal (ULN); Total bilirubin (TBL) within 1.5x ULN (except for individuals diagnosed with Gilbert’s syndrome); and Estimated glomerular filtration rate (eGFR) greater than 40 ml/min/1.73 m^2, which measures kidney function and is calculated by the CKD-EPI formula.
      11. Contraception: If you are sexually active, you must agree to use contraception during the treatment period and for at least 1 week after the last dose of study treatment, and refrain from donating sperm during this period.

      Please let me know if you need further clarification on any of these criteria.

      What Reasons Could Exclude Me from the Study?

      Here is the list of conditions that would make you ineligible to take part in the study along with explanations of medical terms where necessary:

      1. Pathological finding consistent with small cell, ductal or ≥50% component of neuroendocrine carcinoma of the prostate: If your prostate cancer diagnosis includes these specific types, you cannot participate. Neuroendocrine carcinoma is a type of cancer that starts in the hormone-producing cells of the body’s neuroendocrine system.
      2. History of bilateral orchiectomy: If you have had both testicles surgically removed, you cannot participate.
      3. Metastases or recurrent/new malignant lesions in prostate gland/bed seminal vesicles, lymph nodes below the CIA bifurcation on conventional imaging (CI): If there is evidence of cancer spread to these areas as seen on imaging tests, you cannot participate. The CIA bifurcation is where the common iliac artery splits into the internal and external iliac arteries.
      4. Brain metastasis on PSMA PET/CT: If there is evidence of brain metastases, or cancer spread to the brain, as seen on PSMA PET/CT scans, you cannot participate. PSMA PET/CT is an imaging test that helps visualize prostate cancer.
      5. High-risk biochemical recurrence (BCR) after primary radiotherapy with new loco-regional lesions: If you are eligible for curative salvage prostatectomy after having a high-risk BCR and new cancer lesions in the local regional area are observed on screening, you cannot participate.
      6. Prior treatment with second-generation androgen receptor inhibitors (ARIs) and CYP17 inhibitors: If you’ve been treated with drugs like enzalutamide, apalutamide, or abiraterone within 18 months prior to signing the informed consent form, you cannot participate. ARIs and CYP17 inhibitors are used to treat prostate cancer.
      7. Prior treatments with PSMA-radiotherapeutics: If you’ve been treated with PSMA-targeted radiotherapy within 12 months prior to randomization, you cannot participate.
      8. Prior radiotherapy: If you’ve received radiotherapy (including image-guided radiotherapy) as primary, adjuvant, or salvage treatment completed within 8 weeks prior to signing the informed consent form, you cannot participate.
      9. Any prior malignancy: If you’ve had any other cancers (except certain skin cancers, superficial bladder cancer, or any cancer in situ in remission) within the past 5 years, you cannot participate.
      10. History of pelvic radiotherapy for another malignancy: If you’ve received radiotherapy in the pelvic area for another type of cancer, you cannot participate.

      Please note that this is not a comprehensive list, so it is important to consult with the study coordinators for more specific information based on your individual medical history.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Darolutamide (BAY1841788, Nubeqa): This drug is an androgen receptor inhibitor (ARI) used in the treatment of prostate cancer. It blocks the action of male sex hormones like testosterone on prostate cancer cells, which can help stop the growth and spread of cancer. Darolutamide is given as a 300 mg coated tablet taken orally.
      2. Placebo matching darolutamide: This is a placebo that is matched to appear like darolutamide but does not contain any active medication. It is also a coated tablet taken orally.
      3. ADT (Androgen Deprivation Therapy): ADT is a treatment that reduces androgen levels in patients with prostate cancer. It includes luteinizing hormone-releasing hormone (LHRH) agonists or antagonists to stop the body from producing androgens like testosterone.

      These treatments are used in a clinical trial context to evaluate the combination of darolutamide and ADT in prolonging the time that participants live without their cancer getting worse or leading to death, compared to the placebo and ADT combination. The treatment duration is pre-specified to be 24 months.

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

      The active substances participating in the clinical trial are as follows:

      1. Darolutamide (BAY1841788, Nubeqa): This is a new generation androgen receptor inhibitor (ARI), which blocks the action of androgens receptors and is designed for the treatment of prostate cancer. Darolutamide is already an established medicine and known in the medical literature for its application in prostate cancer treatment.
      2. Androgen Deprivation Therapy (ADT): This is not a specific single substance but a treatment approach that reduces androgen levels in the body or blocks androgens from acting on their receptors. ADT includes luteinizing hormone-releasing hormone (LHRH) agonists or antagonists and is used to stop prostate cancer growth. It is a well-known and widely used treatment in the management of prostate cancer.
      3. Placebo: A placebo is used as a comparator in clinical trials. It looks like a medicine but does not contain any active substance. The purpose of a placebo in the study is to serve as a control to determine the effect of the active treatments, which in this case is the combination of darolutamide and ADT.

      Study ID


      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago

      Study phase


      Medicinal Product