<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/NCT01707966</url>
  </required_header>
  <id_info>
    <org_study_id>SAKK 08/11</org_study_id>
    <secondary_id>2011-002965-39</secondary_id>
    <nct_id>NCT01707966</nct_id>
  </id_info>
  <brief_title>Orteronel Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer and Non-progressive Disease After First-line Docetaxel Therapy</brief_title>
  <official_title>Orteronel Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer and Non-progressive Disease After First-line Docetaxel Therapy: a Multicenter Randomized Double-blind Placebo-controlled Phase III Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Group for Clinical Cancer Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swiss Group for Clinical Cancer Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this multicenter, randomized, double-blind, placebo-controlled phase&#xD;
      III trial is to assess the impact of maintenance orteronel on disease progression and hence&#xD;
      on quality of life in patients with metastatic castration-resistant prostate cancer who have&#xD;
      achieved at lease disease stabilization after first line chemotherapy with docetaxel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      One in six men will be diagnosed with cancer of the prostate during his lifetime.&#xD;
      Accordingly, prostate cancer is the most common cancer amongst men in the western world. In&#xD;
      Switzerland approximately 5'400 men are diagnosed with the disease and 1'300 die of prostate&#xD;
      cancer every year. Prostate cancer represents 30% of all cancer diagnoses in men. Despite&#xD;
      earlier detection and new treatments the life time risk to die of prostate cancer has&#xD;
      remained stable at 3% since 1980.&#xD;
&#xD;
      Metastatic prostate cancer is hormone-sensitive and therefore androgen deprivation therapy&#xD;
      (ADT) is the treatment of choice. Yet, virtually all patients with metastatic prostate cancer&#xD;
      progress on androgen deprivation therapy (so called castration-resistant prostate cancer:&#xD;
      CRPC). Further hormonal manipulations are often administered (e.g. maximal androgen blockade&#xD;
      with addition of a non-steroidal antiandrogen such as bicalutamide), however these&#xD;
      interventions have only modest impact. Metastatic CRPC (mCRPC) that progresses despite these&#xD;
      therapies is nowadays treated with docetaxel-based chemotherapy. In a phase III trial,&#xD;
      treatment of mCRPC patients with docetaxel in combination with low dose prednisone resulted&#xD;
      in a significant survival advantage in comparison to the previous standard of care of&#xD;
      mitoxantrone plus prednisone. Moreover docetaxel treatment improved response rate,&#xD;
      progression free survival and symptom control.&#xD;
&#xD;
      The current standard of care in patients with disease stabilization after first line&#xD;
      chemotherapy with docetaxel is a wait-and-watch strategy, where patients are regularly&#xD;
      examined in the hospital every 3-4 weeks. A second line chemotherapy in patients with mCRPC&#xD;
      was not standardized until recently. However, two trials presented in 2010 have changed the&#xD;
      landscape: the novel taxane cabazitaxel was tested in a phase III trial against mitoxantrone&#xD;
      as a second line chemotherapy in patients progressing under or after docetaxel. There was a&#xD;
      significant improvement in overall survival, progression free survival and response rate.&#xD;
      Most of the included patients had experienced disease progression during or within three&#xD;
      months of docetaxel first line treatment. Cabazitaxel was associated with increased toxicity&#xD;
      including 5% toxic deaths. Another randomized phase III trial using abiraterone in patients&#xD;
      with progression after docetaxel showed a significant improvement in overall survival and&#xD;
      pain palliation. Abiraterone belongs to a group of agents that very effectively inhibits the&#xD;
      androgen synthesis via blockade of the key enzyme cytochrome P-450c17 (CYP17).&#xD;
&#xD;
      The new drug orteronel (TAK-700) belongs to the same group of active substances as&#xD;
      abiraterone. Orteronel is currently the subject of a large international Phase III study in&#xD;
      patients with metastatic carcinoma of the prostate and progression of disease following&#xD;
      docetaxel. Initial results have shown that orteronel effectively inhibits testosterone&#xD;
      synthesis and, in contrast to abiraterone, has fewer side effects.&#xD;
&#xD;
      Rational:&#xD;
&#xD;
      CYP17 inhibitors are active and well tolerated agents for treatment of patients with&#xD;
      castration-resistant prostate cancer. However, despite its activity patients become resistant&#xD;
      to this new form of antihormonal treatment and hence develop further progression after a&#xD;
      median of approximately 6 months. In that case, the options are very limited as outlined&#xD;
      above.&#xD;
&#xD;
      In all reported post-docetaxel trials and in the large phase III trials, patients start on&#xD;
      the CYP17 inhibitor treatment at the time of disease progression. Trials examining other&#xD;
      advanced malignant diseases such as lung cancer have shown that initiating an effective&#xD;
      treatment earlier in the disease course at the end of a first-line chemotherapy (so called&#xD;
      switch maintenance therapy) is beneficial in terms of progression free survival (PFS) but&#xD;
      also overall survival (OS). This may also hold true for early administration of antihormonal&#xD;
      agents in patients with mCRPC.&#xD;
&#xD;
      Therefore, the aim of this trial is to test the hypothesis that starting orteronel after&#xD;
      disease stabilization with docetaxel prolongs event-free survival (EFS), consequently&#xD;
      maintains a good quality of life (QL) and eventually also improves OS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Event free survival (EFS)</measure>
    <time_frame>At baseline; every 4 weeks until disease progression (estimated up to 1 year)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AEs)</measure>
    <time_frame>Throughout treatment phase (estimated up to 1 year) until 30 days after last drug administration or prior to start of subsequent anticancer treatment (whichever occurs first)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate-specific antigen (PSA) response (30%, 50%, 90% and best)</measure>
    <time_frame>PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to PSA progression</measure>
    <time_frame>PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic progression-free survival (rPFS)</measure>
    <time_frame>Every 12 weeks until disease progression (estimated up to 1 year)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QL and pain response</measure>
    <time_frame>First 6 months of trial treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>time from trial randomization to the date of death from any cause (estimated up to 4 years)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Orteronel and best supportive care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm A: 300mg Orteronel twice daily and best supportive care until occurrence of an event.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo and best supportive care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Arm B: Placebo twice daily and best supportive care until occurrence of an event.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Orteronel</intervention_name>
    <arm_group_label>Orteronel and best supportive care</arm_group_label>
    <other_name>TAK-700</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo and best supportive care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has given voluntary written informed consent&#xD;
&#xD;
          -  Male patient 18 years or older&#xD;
&#xD;
          -  WHO performance status of ≤2&#xD;
&#xD;
          -  Adenocarcinoma of the prostate&#xD;
&#xD;
          -  Castration resistance: tumor progression after orchiectomy or during treatment with&#xD;
             GnRH analogues&#xD;
&#xD;
          -  Metastatic disease, radiographically documented (&#xD;
&#xD;
          -  Total testosterone ≤ 50 ng/dL&#xD;
&#xD;
          -  Non-progressive disease after docetaxel first-line treatment with a cumulative dose ≥&#xD;
             300mg/m2&#xD;
&#xD;
               -  No evidence of progression on imaging according to PCWG2 and modified RECIST 1.1&#xD;
                  criteria&#xD;
&#xD;
               -  PSA levels not elevated ≥ 25% AND at least 2 ng/mL above the nadir since start of&#xD;
                  docetaxel treatment&#xD;
&#xD;
          -  Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or&#xD;
             antagonists) during the trial&#xD;
&#xD;
          -  PSA ≥ 2 ng/mL; Potassium ≥ 3.5 mmol/L; Neutrophils ≥ 1.5 x 109/L; Platelets ≥ 100 x&#xD;
             10x9/L&#xD;
&#xD;
          -  Normal kidney and liver function&#xD;
&#xD;
          -  Planned start of trial treatment 3 to 6 weeks after last docetaxel administration&#xD;
&#xD;
          -  Screening calculated ejection fraction of ≥ 50% or normal according to local standard&#xD;
             by echocardiogram or by multiple gated acquisition (MUGA) scan.&#xD;
&#xD;
          -  Baseline QL questionnaire completed&#xD;
&#xD;
          -  Patient is able and willing to swallow study drug as whole tablet&#xD;
&#xD;
          -  Patient compliance and geographic proximity allow proper staging and follow-up&#xD;
&#xD;
          -  Patient agrees to practice effective barrier contraception or to completely abstain&#xD;
             from intercourse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior therapy with aminoglutethimide, ketoconazole, orteronel, abiraterone or other&#xD;
             modern CYP17 inhibitors&#xD;
&#xD;
          -  Prior chemotherapy for prostate cancer within 12 months before enrollment except from&#xD;
             docetaxel&#xD;
&#xD;
          -  Retreatment with docetaxel after interruption of &gt; 5 weeks&#xD;
&#xD;
          -  Concurrent disease requiring higher doses of corticosteroid than the equivalent of 10&#xD;
             mg prednisone per day&#xD;
&#xD;
          -  Known hypersensitivity to trial drug or hypersensitivity to any of its components&#xD;
&#xD;
          -  Patient has received other investigational drugs within 30 days before enrollment&#xD;
&#xD;
          -  Presence of a small cell component in histological specimen&#xD;
&#xD;
          -  Radiotherapy within the last 2 weeks before expected start of the trial treatment&#xD;
&#xD;
          -  Known history of central nervous system (CNS) or spinal cord metastases&#xD;
&#xD;
          -  Current spinal cord compression&#xD;
&#xD;
          -  Diagnosed or treated for another malignancy within 2 years of registration, with the&#xD;
             exception of complete resection of basal cell carcinoma or squamous cell carcinoma of&#xD;
             the skin, or any in situ malignancies&#xD;
&#xD;
          -  History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing&#xD;
             arrhythmias of Grade ≥ 3 (NCI CTCAE version 4.0) or thromboembolic events (e.g., deep&#xD;
             vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events) within 6&#xD;
             months prior to first dose of study drug. Chronic stable atrial fibrillation on stable&#xD;
             anticoagulant therapy is allowed&#xD;
&#xD;
          -  New York Heart Association Class III or IV heart failure&#xD;
&#xD;
          -  ECG abnormalities of:&#xD;
&#xD;
               -  Q-wave infarction, unless identified ≥ 6 months prior to registration&#xD;
&#xD;
               -  QTc interval &gt; 460 msec&#xD;
&#xD;
          -  Uncontrolled hypertension despite appropriate medical therapy&#xD;
&#xD;
          -  Likely inability (e.g. due to a psychiatric disorder) to understand information on&#xD;
             trial related topics, to give informed consent, to comply with the protocol, to fill&#xD;
             in QL forms and to cooperate fully with the investigator and site personnel&#xD;
&#xD;
          -  Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI&#xD;
             absorption or tolerance of orteronel&#xD;
&#xD;
          -  Known active chronic hepatitis B or C, life-threatening illness unrelated to cancer,&#xD;
             or any serious medical or psychiatric illness that could, in the investigator's&#xD;
             opinion, potentially interfere with participation in this study&#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>Richard Cathomas, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Kantonsspital Graubünden</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Silke Gillessen, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Cantonal Hospital of St. Gallen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kantonspital Aarau</name>
      <address>
        <city>Aarau</city>
        <zip>CH-5001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsspital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli</name>
      <address>
        <city>Bellinzona</city>
        <zip>6500</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern</name>
      <address>
        <city>Bern</city>
        <zip>CH-3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Graubuenden</name>
      <address>
        <city>Chur</city>
        <zip>7000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>1708</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Genève HUG</name>
      <address>
        <city>Geneva 14</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois CHUV</name>
      <address>
        <city>Lausanne</city>
        <zip>CH-1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Luzern</name>
      <address>
        <city>Luzern</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spital Männedorf</name>
      <address>
        <city>Männedorf</city>
        <zip>8708</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Muensterlingen</name>
      <address>
        <city>Münsterlingen</city>
        <zip>8596</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St. Gallen</name>
      <address>
        <city>St. Gallen</city>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SpitalSTS AG Simmental-Thun-Saanenland</name>
      <address>
        <city>Thun</city>
        <zip>3600</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Winterthur</name>
      <address>
        <city>Winterthur</city>
        <zip>8401</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UniversitaetsSpital Zuerich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Cathomas R, Crabb SJ, Mark M, Winterhalder R, Rothermundt C, Elliott T, von Burg P, Kenner H, Hayoz S, Vilei SB, Rauch D, Roggero E, Mohaupt MG, Bernhard J, Manetsch G, Gillessen S; Swiss Group for Clinical Cancer Research SAKK. Orteronel Switch Maintenance Therapy in Metastatic Castration Resistant Prostate Cancer After First-Line Docetaxel: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (SAKK 08/11). Prostate. 2016 Dec;76(16):1519-1527. doi: 10.1002/pros.23236. Epub 2016 Jul 25.</citation>
    <PMID>27457964</PMID>
  </results_reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>May 13, 2019</last_update_submitted>
  <last_update_submitted_qc>May 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adenocarcinoma of the prostate</keyword>
  <keyword>metastatic castration-resistant prostate cancer</keyword>
  <keyword>maintenance therapy</keyword>
  <keyword>orteronel</keyword>
  <keyword>TAK-700</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/NCT01707966
org study id: SAKK 08/11
secondary id: 2011-002965-39
nct id: NCT01707966
lead sponsor: 
has dmc: No
The main objective of this multicenter, randomized, double-blind, placebo-controlled phase
      III trial is to assess the impact of maintenance orteronel on disease progression and hence
      on quality of life in patients with metastatic castration-resistant prostate cancer who have
      achieved at lease disease stabilization after first line chemotherapy with docetaxel.
Background:

      One in six men will be diagnosed with cancer of the prostate during his lifetime.
      Accordingly, prostate cancer is the most common cancer amongst men in the western world. In
      Switzerland approximately 5'400 men are diagnosed with the disease and 1'300 die of prostate
      cancer every year. Prostate cancer represents 30% of all cancer diagnoses in men. Despite
      earlier detection and new treatments the life time risk to die of prostate cancer has
      remained stable at 3% since 1980.

      Metastatic prostate cancer is hormone-sensitive and therefore androgen deprivation therapy
      (ADT) is the treatment of choice. Yet, virtually all patients with metastatic prostate cancer
      progress on androgen deprivation therapy (so called castration-resistant prostate cancer:
      CRPC). Further hormonal manipulations are often administered (e.g. maximal androgen blockade
      with addition of a non-steroidal antiandrogen such as bicalutamide), however these
      interventions have only modest impact. Metastatic CRPC (mCRPC) that progresses despite these
      therapies is nowadays treated with docetaxel-based chemotherapy. In a phase III trial,
      treatment of mCRPC patients with docetaxel in combination with low dose prednisone resulted
      in a significant survival advantage in comparison to the previous standard of care of
      mitoxantrone plus prednisone. Moreover docetaxel treatment improved response rate,
      progression free survival and symptom control.

      The current standard of care in patients with disease stabilization after first line
      chemotherapy with docetaxel is a wait-and-watch strategy, where patients are regularly
      examined in the hospital every 3-4 weeks. A second line chemotherapy in patients with mCRPC
      was not standardized until recently. However, two trials presented in 2010 have changed the
      landscape: the novel taxane cabazitaxel was tested in a phase III trial against mitoxantrone
      as a second line chemotherapy in patients progressing under or after docetaxel. There was a
      significant improvement in overall survival, progression free survival and response rate.
      Most of the included patients had experienced disease progression during or within three
      months of docetaxel first line treatment. Cabazitaxel was associated with increased toxicity
      including 5% toxic deaths. Another randomized phase III trial using abiraterone in patients
      with progression after docetaxel showed a significant improvement in overall survival and
      pain palliation. Abiraterone belongs to a group of agents that very effectively inhibits the
      androgen synthesis via blockade of the key enzyme cytochrome P-450c17 (CYP17).

      The new drug orteronel (TAK-700) belongs to the same group of active substances as
      abiraterone. Orteronel is currently the subject of a large international Phase III study in
      patients with metastatic carcinoma of the prostate and progression of disease following
      docetaxel. Initial results have shown that orteronel effectively inhibits testosterone
      synthesis and, in contrast to abiraterone, has fewer side effects.

      Rational:

      CYP17 inhibitors are active and well tolerated agents for treatment of patients with
      castration-resistant prostate cancer. However, despite its activity patients become resistant
      to this new form of antihormonal treatment and hence develop further progression after a
      median of approximately 6 months. In that case, the options are very limited as outlined
      above.

      In all reported post-docetaxel trials and in the large phase III trials, patients start on
      the CYP17 inhibitor treatment at the time of disease progression. Trials examining other
      advanced malignant diseases such as lung cancer have shown that initiating an effective
      treatment earlier in the disease course at the end of a first-line chemotherapy (so called
      switch maintenance therapy) is beneficial in terms of progression free survival (PFS) but
      also overall survival (OS). This may also hold true for early administration of antihormonal
      agents in patients with mCRPC.

      Therefore, the aim of this trial is to test the hypothesis that starting orteronel after
      disease stabilization with docetaxel prolongs event-free survival (EFS), consequently
      maintains a good quality of life (QL) and eventually also improves OS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Event free survival (EFS)
time frame: At baseline; every 4 weeks until disease progression (estimated up to 1 year)
measure: Adverse events (AEs)
time frame: Throughout treatment phase (estimated up to 1 year) until 30 days after last drug administration or prior to start of subsequent anticancer treatment (whichever occurs first)
measure: Prostate-specific antigen (PSA) response (30%, 50%, 90% and best)
time frame: PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year)
measure: Time to PSA progression
time frame: PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year)
measure: Radiographic progression-free survival (rPFS)
time frame: Every 12 weeks until disease progression (estimated up to 1 year)
measure: QL and pain response
time frame: First 6 months of trial treatment
measure: Overall survival (OS)
time frame: time from trial randomization to the date of death from any cause (estimated up to 4 years)
arm group label: Orteronel and best supportive care
arm group type: Experimental
description: Arm A: 300mg Orteronel twice daily and best supportive care until occurrence of an event.
arm group label: Placebo and best supportive care
arm group type: Placebo Comparator
description: Arm B: Placebo twice daily and best supportive care until occurrence of an event.
intervention type: Drug
intervention name: Orteronel
arm group label: Orteronel and best supportive care
other name: TAK-700
intervention type: Drug
intervention name: Placebo
arm group label: Placebo and best supportive care
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Cathomas, MD
role: Study Chair
affiliation: Kantonsspital Graubünden
last name: Silke Gillessen, Prof
role: Study Chair
affiliation: Cantonal Hospital of St. Gallen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Switzerland
citation: Cathomas R, Crabb SJ, Mark M, Winterhalder R, Rothermundt C, Elliott T, von Burg P, Kenner H, Hayoz S, Vilei SB, Rauch D, Roggero E, Mohaupt MG, Bernhard J, Manetsch G, Gillessen S; Swiss Group for Clinical Cancer Research SAKK. Orteronel Switch Maintenance Therapy in Metastatic Castration Resistant Prostate Cancer After First-Line Docetaxel: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (SAKK 08/11). Prostate. 2016 Dec;76(16):1519-1527. doi: 10.1002/pros.23236. Epub 2016 Jul 25.
PMID: 27457964
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No