<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02972060</url>
  </required_header>
  <id_info>
    <org_study_id>EORTC-1532</org_study_id>
    <secondary_id>2016-004334-17</secondary_id>
    <nct_id>NCT02972060</nct_id>
  </id_info>
  <brief_title>ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer</brief_title>
  <official_title>A Phase 2 Randomized Open-Label Study of Oral Darolutamide (ODM-201) vs. Androgen Deprivation Therapy (ADT) With LHRH Agonists or Antagonist in Men With Hormone Naive Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>European Organisation for Research and Treatment of Cancer - EORTC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label non-comparative controlled randomized phase II study. The experimental&#xD;
      arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is&#xD;
      included as an internal control.&#xD;
&#xD;
      The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen&#xD;
      (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in&#xD;
      the range of those achieved with 24 weeks of ADT.&#xD;
&#xD;
      In total, this 1:1 randomized study will therefore require randomization of at least 250&#xD;
      patients, 125 to each arm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be&#xD;
      administered is 600 milligrams (mg) (2 x 300-mg tablets) twice daily (bid) for a daily dose&#xD;
      of 1200 mg. It is recommended that ODM-201 be taken with food.&#xD;
&#xD;
      Subjects who have clinical benefit at week 24 may continue to receive ODM-201 at the&#xD;
      discretion of the investigator until disease progression, objective or clinical, or&#xD;
      occurrence of an unacceptable toxicity. This includes those that will receive external beam&#xD;
      radiation therapy.&#xD;
&#xD;
      Any anti-cancer therapy other than the study drug given as single agent will not be&#xD;
      considered part of the protocol treatment.&#xD;
&#xD;
      The standard treatment for this stage of the disease is androgen deprivation therapy (ADT) by&#xD;
      means of Luteinizing hormone-releasing hormone (LHRH) antagonist for 24 weeks or by LHRH&#xD;
      agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.&#xD;
&#xD;
      This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the&#xD;
      treatment will be left to the discretion of the treating physician.&#xD;
&#xD;
      The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen&#xD;
      (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in&#xD;
      the range of those achieved with 24 weeks of ADT.&#xD;
&#xD;
      The secondary objectives are to:&#xD;
&#xD;
        -  To document the effects of ODM-201 compared to ADT in terms of patient-reported side&#xD;
           effects of hormonal therapy, based on the Hormonal treatment (HTR) symptom scale of&#xD;
           EORTC QLQ PR25 at 24 weeks;&#xD;
&#xD;
        -  To document the effects of ODM-201 compared to ADT in terms of patient-reported side&#xD;
           effects of hormonal therapy, based on EORTC QLQ C30 and PR25 at 24 weeks;&#xD;
&#xD;
        -  To document the effect of ODM-201 on PSA complete response at 24 weeks (defined as ≥ 90%&#xD;
           reduction from baseline);&#xD;
&#xD;
        -  To document the effect of ODM-201 on objective response rate at 24 weeks in patients&#xD;
           with RECIST 1.1 measurable disease at baseline;&#xD;
&#xD;
        -  To document the safety and tolerability of ODM-201 vs. ADT in subjects who have not&#xD;
           previously received hormone treatment for prostate cancer;&#xD;
&#xD;
        -  To document the effects of ODM-201 on androgen deprivations symptoms using the Aging&#xD;
           male symptoms (AMS) questionnaires;&#xD;
&#xD;
        -  To document the proportion of patients who opted to continue treatment with ODM-201&#xD;
           beyond the protocolized 24 weeks&#xD;
&#xD;
      The primary endpoint is the PSA response assessed at 24 weeks. PSA response is defined as a ≥&#xD;
      80% decline in PSA measurement taken at week 24 relative to the measurement taken at&#xD;
      baseline, in the ODM-201 study arm. The ADT arm is used as an internal control.&#xD;
&#xD;
      Key secondary endpoints:&#xD;
&#xD;
        -  Change in hormone-treatment related symptoms scale of the EORTC QLQ-PR25 at 24 weeks&#xD;
           compared to baseline in the ODM-201 study arm. A 10-point difference is regarded as a&#xD;
           clinically meaningful benefit.&#xD;
&#xD;
        -  Objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at&#xD;
           baseline&#xD;
&#xD;
        -  PSA response at 24 weeks defined as a ≥90% decline in PSA compared to baseline&#xD;
&#xD;
        -  Safety according to National Cancer Institute - Common terminology for adverse events&#xD;
           (NCI-CTC) version 4.0&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PSA response</measure>
    <time_frame>24 weeks</time_frame>
    <description>PSA response is defined as a ≥ 80% decline in PSA measurement taken at week 24 relative to the measurement taken at baseline, in the ODM-201 study arm. The ADT arm is used as an internal control.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-PR25</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change in hormone-treatment related symptoms scale of the EORTC QLQ-PR25 at 24 weeks compared to baseline in the ODM-201 study arm. A 10-point difference is regarded as a clinically meaningful benefit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective tumor response</measure>
    <time_frame>24 weeks</time_frame>
    <description>Objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90% PSA response rate</measure>
    <time_frame>24 weeks</time_frame>
    <description>PSA response at 24 weeks defined as a ≥90% decline in PSA compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation of safety</measure>
    <time_frame>The collection period will start from randomization until 30 days after last protocol treatment administration.</time_frame>
    <description>All adverse events will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>ADT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The standard treatment for this stage of the disease is ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.&#xD;
This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ODM 201</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) bid for a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food.&#xD;
Subjects who have clinical benefit at week 24 may continue to receive ODM-201 at the discretion of the investigator until disease progression, objective or clinical, or occurrence of an unacceptable toxicity. This includes those that will receive external beam radiation therapy.&#xD;
Any anti-cancer therapy other than the study drug given as single agent will not be considered part of the protocol treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ODM-201</intervention_name>
    <description>ODM-201 is a novel, oral, potent nonsteroidal AR inhibitor. ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) b.i.d. to a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food. Treatment should be initiated within 28 days from randomization.</description>
    <arm_group_label>ODM 201</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ADT</intervention_name>
    <description>ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.&#xD;
This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician.</description>
    <arm_group_label>ADT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed prostate cancer (all stages) for whom continuous&#xD;
             androgen-deprivation therapy (ADT) is indicated for a minimum period of 24 weeks&#xD;
&#xD;
          -  Patient presenting with a maximum of 4 confirmed metastatic lesions, including bone,&#xD;
             extra-pelvic lymph nodes, and pelvic lymph nodes &gt; 2 cm on baseline Computed&#xD;
             tomography(CT) or Magnetic resonance imaging (MRI) and/or Tc bone scintigraphy.&#xD;
             Visceral metastases are excluded&#xD;
&#xD;
          -  Asymptomatic for metastatic prostate cancer; urinary symptoms are allowed&#xD;
&#xD;
          -  Baseline testosterone ≥ 8 nmol/L or 230 ng/dL&#xD;
&#xD;
          -  Two subsequent PSA values ≥ 2 ng/ml, taken at minimum 2-week interval, with the second&#xD;
             being equal to or higher than the first one&#xD;
&#xD;
          -  WHO performance status (PS) of 0-1&#xD;
&#xD;
          -  G8 score ≥ 14 for patients aged ≥ 70 years old&#xD;
&#xD;
          -  A life expectancy of at least 12 months&#xD;
&#xD;
          -  Able to swallow the study drug and comply with the study requirements&#xD;
&#xD;
          -  Adequate bone marrow function (absolute neutrophil count (ANC) ≥ 1.5 10exp9/L;&#xD;
             hemoglobin ≥ 10.0 g/dl, platelets ≥ 100 10exp9/L)&#xD;
&#xD;
          -  Adequate renal function: creatinine clearance/eGFR within normal limits to baseline&#xD;
             assessed as per local standard method&#xD;
&#xD;
          -  Albumin &gt; 25 g/L&#xD;
&#xD;
          -  Adequate hepatic function:&#xD;
&#xD;
        Bilirubin: total bilirubin ≤ to 1.5 X upper limit of normal (ULN)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and/or Alanine aminotransferase(ALT) ≤ 2.5 X ULN&#xD;
&#xD;
          -  Normal cardiac function according to local standard by 12-lead Electrocardiogram (ECG)&#xD;
             (complete, standardized 12-lead recording)&#xD;
&#xD;
          -  Before patient registration/randomization, written informed consent must be given&#xD;
             according to International Conference on Harmonization on Good Clinical Practices&#xD;
             (ICH/GCP), and national/local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any psychological, familial, sociological or geographical condition potentially&#xD;
             hampering compliance with the study protocol and follow-up schedule&#xD;
&#xD;
          -  Previously or currently receiving hormonal therapy with intent to treat prostate&#xD;
             cancer disease (surgical castration or other hormonal manipulation, e.g. GnRH&#xD;
             agonists, GnRH antagonists, anti-androgens, oestrogens, 5α-reductase inhibitor). For&#xD;
             patients that have received (neo)adjuvant ADT before radiotherapy, it should have been&#xD;
             stopped for more than 1 year&#xD;
&#xD;
          -  Prior use of investigational agents that block androgen synthesis or block androgen&#xD;
             receptor&#xD;
&#xD;
          -  Use of herbal products that may have hormonal anti-prostate cancer activity and/or are&#xD;
             known to decrease PSA levels (e.g. saw palmetto)&#xD;
&#xD;
          -  Has received systemic glucocorticoids within 24 weeks prior to enrollment or is&#xD;
             expected to require systemic glucocorticoids during the study period&#xD;
&#xD;
          -  Radiation therapy for treatment of the primary tumor within 3 months prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Use of an investigational agent within 4 weeks prior to enrollment is not allowed. The&#xD;
             maximum allowed duration may be extended to comply with national regulations in the&#xD;
             participating countries.&#xD;
&#xD;
          -  Gastrointestinal disorder affecting absorption (e.g. gastrectomy, active peptic ulcer&#xD;
             disease within 3 months prior to enrollment)&#xD;
&#xD;
          -  Known hypersensitivity to the study treatment or any of its ingredients (refer to&#xD;
             Investigator's brochure).&#xD;
&#xD;
          -  Severe or uncontrolled concurrent disease, infection or co-morbidity including active&#xD;
             viral hepatitis, known human immunodeficiency virus infection with detectable viral&#xD;
             load (Human immunodeficiency virus (HIV)) or chronic liver disease&#xD;
&#xD;
          -  History of prior malignancy. Adequately treated basal cell or squamous cell carcinoma&#xD;
             of skin or superficial bladder cancer that has not spread behind the connective tissue&#xD;
             layer (i.e. pTis, pTa, and pT1) is allowed, as well as any other cancer for which&#xD;
             chemotherapy has been completed ≤ 5 years ago and from which the patient has been&#xD;
             disease-free.&#xD;
&#xD;
          -  Clinically significant cardiovascular disease including:&#xD;
&#xD;
          -  Myocardial infarction within six months prior to randomization&#xD;
&#xD;
          -  Uncontrolled angina within 3 months prior to randomization&#xD;
&#xD;
          -  Coronary/peripheral artery bypass within 6 months prior to randomization&#xD;
&#xD;
          -  Stroke within 6 months prior to randomization&#xD;
&#xD;
          -  Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects&#xD;
             with history of congestive heart failure NYHA class 3 or 4 in the past, unless a&#xD;
             screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3&#xD;
             months results in a left ventricular ejection fraction that is ≥ 45%&#xD;
&#xD;
          -  History of clinically significant ventricular arrhythmias (e.g., ventricular&#xD;
             tachycardia, ventricular fibrillation, torsades de pointes)&#xD;
&#xD;
          -  History of Mobitz II second degree or third degree heart block without a permanent&#xD;
             pacemaker in place&#xD;
&#xD;
          -  Uncontrolled hypertension as indicated by a resting systolic blood pressure &gt;170 mm Hg&#xD;
             or diastolic blood pressure &gt; 105 mm Hg at the screening visit&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bertrand Tombal, Pr</last_name>
    <role>Study Chair</role>
    <affiliation>Cliniques universitaires saint-Luc (Brussels)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dinant Godinne - UCL Namur</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon - Centre Georges-Francois-Leclerc</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Ospedale Molinette</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen De La Victoria</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Instituto Valenciano De Oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Italy</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hormone Naive Prostate Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02972060
org study id: EORTC-1532
secondary id: 2016-004334-17
nct id: NCT02972060
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an open label non-comparative controlled randomized phase II study. The experimental
      arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is
      included as an internal control.

      The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen
      (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in
      the range of those achieved with 24 weeks of ADT.

      In total, this 1:1 randomized study will therefore require randomization of at least 250
      patients, 125 to each arm.
ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be
      administered is 600 milligrams (mg) (2 x 300-mg tablets) twice daily (bid) for a daily dose
      of 1200 mg. It is recommended that ODM-201 be taken with food.

      Subjects who have clinical benefit at week 24 may continue to receive ODM-201 at the
      discretion of the investigator until disease progression, objective or clinical, or
      occurrence of an unacceptable toxicity. This includes those that will receive external beam
      radiation therapy.

      Any anti-cancer therapy other than the study drug given as single agent will not be
      considered part of the protocol treatment.

      The standard treatment for this stage of the disease is androgen deprivation therapy (ADT) by
      means of Luteinizing hormone-releasing hormone (LHRH) antagonist for 24 weeks or by LHRH
      agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.

      This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the
      treatment will be left to the discretion of the treating physician.

      The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen
      (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in
      the range of those achieved with 24 weeks of ADT.

      The secondary objectives are to:

        -  To document the effects of ODM-201 compared to ADT in terms of patient-reported side
           effects of hormonal therapy, based on the Hormonal treatment (HTR) symptom scale of
           EORTC QLQ PR25 at 24 weeks;

        -  To document the effects of ODM-201 compared to ADT in terms of patient-reported side
           effects of hormonal therapy, based on EORTC QLQ C30 and PR25 at 24 weeks;

        -  To document the effect of ODM-201 on PSA complete response at 24 weeks (defined as ≥ 90%
           reduction from baseline);

        -  To document the effect of ODM-201 on objective response rate at 24 weeks in patients
           with RECIST 1.1 measurable disease at baseline;

        -  To document the safety and tolerability of ODM-201 vs. ADT in subjects who have not
           previously received hormone treatment for prostate cancer;

        -  To document the effects of ODM-201 on androgen deprivations symptoms using the Aging
           male symptoms (AMS) questionnaires;

        -  To document the proportion of patients who opted to continue treatment with ODM-201
           beyond the protocolized 24 weeks

      The primary endpoint is the PSA response assessed at 24 weeks. PSA response is defined as a ≥
      80% decline in PSA measurement taken at week 24 relative to the measurement taken at
      baseline, in the ODM-201 study arm. The ADT arm is used as an internal control.

      Key secondary endpoints:

        -  Change in hormone-treatment related symptoms scale of the EORTC QLQ-PR25 at 24 weeks
           compared to baseline in the ODM-201 study arm. A 10-point difference is regarded as a
           clinically meaningful benefit.

        -  Objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at
           baseline

        -  PSA response at 24 weeks defined as a ≥90% decline in PSA compared to baseline

        -  Safety according to National Cancer Institute - Common terminology for adverse events
           (NCI-CTC) version 4.0
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PSA response
time frame: 24 weeks
description: PSA response is defined as a ≥ 80% decline in PSA measurement taken at week 24 relative to the measurement taken at baseline, in the ODM-201 study arm. The ADT arm is used as an internal control.
measure: EORTC QLQ-PR25
time frame: 24 weeks
description: Change in hormone-treatment related symptoms scale of the EORTC QLQ-PR25 at 24 weeks compared to baseline in the ODM-201 study arm. A 10-point difference is regarded as a clinically meaningful benefit.
measure: Objective tumor response
time frame: 24 weeks
description: Objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at baseline
measure: 90% PSA response rate
time frame: 24 weeks
description: PSA response at 24 weeks defined as a ≥90% decline in PSA compared to baseline
measure: evaluation of safety
time frame: The collection period will start from randomization until 30 days after last protocol treatment administration.
description: All adverse events will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events.
arm group label: ADT
arm group type: Active Comparator
description: The standard treatment for this stage of the disease is ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.
This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician.
arm group label: ODM 201
arm group type: Experimental
description: ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) bid for a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food.
Subjects who have clinical benefit at week 24 may continue to receive ODM-201 at the discretion of the investigator until disease progression, objective or clinical, or occurrence of an unacceptable toxicity. This includes those that will receive external beam radiation therapy.
Any anti-cancer therapy other than the study drug given as single agent will not be considered part of the protocol treatment.
intervention type: Drug
intervention name: ODM-201
description: ODM-201 is a novel, oral, potent nonsteroidal AR inhibitor. ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) b.i.d. to a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food. Treatment should be initiated within 28 days from randomization.
arm group label: ODM 201
intervention type: Drug
intervention name: ADT
description: ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.
This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician.
arm group label: ADT
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bertrand Tombal, Pr
role: Study Chair
affiliation: Cliniques universitaires saint-Luc (Brussels)
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country: Belgium
country: France
country: Italy
country: Spain
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No