<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/NCT03819101</url>
  </required_header>
  <id_info>
    <org_study_id>2017-004639-35</org_study_id>
    <secondary_id>2017/2601</secondary_id>
    <nct_id>NCT03819101</nct_id>
  </id_info>
  <brief_title>Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer</brief_title>
  <acronym>PEACE-4</acronym>
  <official_title>A Phase III Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gustave Roussy, Cancer Campus, Grand Paris</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 a 2x2 factorial randomized, multicenter, international, open phase III trial.&#xD;
&#xD;
      The primary objective is to evaluate the benefit of acetylsalicylic acid and atorvastatin on&#xD;
      overall survival (OS) (main endpoint) for patients with castrate-resistant prostate cancer&#xD;
      starting first line treatment for CRPC&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 6, 2019</start_date>
  <completion_date type="Anticipated">March 2038</completion_date>
  <primary_completion_date type="Anticipated">March 2034</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>Factorial Assignment</intervention_model>
    <intervention_model_description>This is a 2x2 factorial randomized, multicenter, international, open phase III trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>OS will be calculated from the date of randomization to the date of death up to 15 years</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">1210</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of Care (SOC) for CRPC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SOC + acetylsalicylic acid 100 mg daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SOC + atorvastatin 80 mg daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SOC + acetylsalicylic acid 100 mg daily + atorvastatin 8</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetylsalicylic acid</intervention_name>
    <description>100mg</description>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_label>Arm D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>80 mg</description>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_label>Arm D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed adenocarcinoma of the prostate and no curative local therapy&#xD;
             considered possible&#xD;
&#xD;
          -  Age ≥ 18 years, life expectancy of at least 6 months&#xD;
&#xD;
          -  CRPC defined as tumor progression (PSA increase on at least 2 separate values&#xD;
             separated by at least 1 week or progression on imaging) while on Androgen Deprivation&#xD;
             Therapy (orchiectomy, LHRH agonist or -antagonist) with documented serum testosterone&#xD;
             levels ≤ 1.7 nmol/L (≤ 0.50 ng/mL). Ongoing concurrent use of LHRH agonist or&#xD;
             antagonist is required if the patient has not been surgically castrated&#xD;
&#xD;
          -  Presence (M1) or absence (M0) of metastases on imaging&#xD;
&#xD;
          -  Performance status 0, 1 or 2&#xD;
&#xD;
          -  No previous use of life- prolonging treatments for CRPC (including abiraterone,&#xD;
             enzalutamide, radium-223, docetaxel, cabazitaxel, and sipuleucel-T). The use of these&#xD;
             agents together with Androgen Deprivation Therapy (ADT) for castrate-sensitive disease&#xD;
             is allowed.&#xD;
&#xD;
          -  Adequate renal function within 30 days prior to registration: calculated creatinine&#xD;
             clearance ≥ 50 mL/min, according to the formula of Cockcroft-Gault and adequate liver&#xD;
             function with levels of AST and ALT ≤ 3xULN and no signs for cholestasis.&#xD;
&#xD;
          -  Participation in other clinical trials is allowed except for trials with the same&#xD;
             primary endpoint, i.e. OS&#xD;
&#xD;
          -  Patient authorized to participate to a clinical trial by specific country regulation&#xD;
             (eg patient affiliated to a social security system or beneficiary of the same)&#xD;
&#xD;
          -  Information delivered to patient and informed consent form signed by the patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous localised malignancy within 2 years with the exception of localized&#xD;
             non-melanoma skin cancer and Ta or Tis bladder cancer (patients with asymptomatic&#xD;
             Chronic Lymphocytic Leukemia can be included)&#xD;
&#xD;
          -  Previous metastatic malignancy within 5 years&#xD;
&#xD;
          -  Patient currently taking daily acetylsalicylic acid or a daily statin within the last&#xD;
             6 months&#xD;
&#xD;
          -  Patients with active liver disease (hepatitis B or C, cirrhosis) or unexplained&#xD;
             persistent elevations of serum transaminases exceeding 3 times the upper limit of&#xD;
             normal or cholestasis&#xD;
&#xD;
          -  Patients with excessive alcohol intake or history of a relevant liver disease&#xD;
&#xD;
          -  Known hypersensitivity or intolerance to acetylsalicylic acid or atorvastatin or&#xD;
             hypersensitivity to any of its components&#xD;
&#xD;
          -  Contra-indication to acetylsalicylic acid or atorvastatin according to label,&#xD;
             including known high-risk for haemorrhage,&#xD;
&#xD;
          -  History of or active myopathy or significantly elevated (&gt; 5 times ULN) CK levels&#xD;
&#xD;
          -  History of recent stroke or transient ischemic attack (TIA).&#xD;
&#xD;
          -  Any concomitant drugs contraindicated for use with the trial drugs according to the&#xD;
             product information (e.g. Fusidic acid, potent inhibitors of CYP3A4 or transport&#xD;
             proteins: ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol,&#xD;
             ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors&#xD;
             including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir,&#xD;
             telaprevir, saquinavir, darunavir, fosamprenavir, boceprevir, gemfibrozil,&#xD;
             fenofibrate, etc)&#xD;
&#xD;
          -  Any serious underlying medical condition (by the investigator's judgement) which could&#xD;
             impair the ability of the patient to participate in the trial&#xD;
&#xD;
          -  Patients with hereditary galactose intolerance, Lapp-lactase deficiency or&#xD;
             Glucose-Galactose-malabsorption&#xD;
&#xD;
          -  Compliance with trial medical follow-up impossible due to geographic, social or&#xD;
             psychological reasons&#xD;
&#xD;
          -  Psychiatric disorder precluding understanding of information about trial related&#xD;
             topics, providing informed consent, or interfering with compliance for oral drug&#xD;
             intake&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Prostate cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Karim Fizazi, MD, PhD</last_name>
    <phone>+33 (0)1 42 11 43 17</phone>
    <email>karim.fizazi@gustaveroussy.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gwenael Le Teuff</last_name>
    <phone>+33 (0)1 42 11 49 55</phone>
    <email>gwenael.leteuff@gustaveroussy.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gustave Roussy Cancer Campus Grand Paris</name>
      <address>
        <city>Villejuif</city>
        <state>Val De Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karim Fizazi, MD, PhD</last_name>
      <phone>+33 (0)1 42 11 43 17</phone>
      <email>karim.fizazi@gustaveroussy.fr</email>
    </contact>
    <contact_backup>
      <last_name>Anne Sophie Hue</last_name>
      <phone>+33 (0)1 42 11 38 90</phone>
      <email>anne-sophie.hue@gustaveroussy.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>CHU Besançon Hopital Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoine Thiery-Vuillemin, MD</last_name>
      <email>antoine.thieryvuillemin@oncologyfc2.onmicrosoft.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hakim Mahammedi, MD</last_name>
      <phone>+33 (0)4 73 27 81 41</phone>
      <email>Hakim.MAHAMMEDI@clermont.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Privé Sainte Marguerite</name>
      <address>
        <city>Hyères</city>
        <zip>83400</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-François Berdah, MD</last_name>
      <phone>+33 (0)4 94 12 55 60</phone>
      <email>jf.berdah@wanadoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Azuréen de Cancérologie</name>
      <address>
        <city>Mougins</city>
        <zip>06250</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe Ronchin, MD</last_name>
      <phone>+33 (0)4 92 92 37 37</phone>
      <email>ronchinp@yahoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Delphine Borchiellini, MD</last_name>
      <email>Delphine.BORCHIELLINI@nice.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Croix Saint Simon</name>
      <address>
        <city>Paris</city>
        <zip>75960</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Camille Serrate, MD</last_name>
      <email>cserrate@hopital-dcss.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Jean Godinot</name>
      <address>
        <city>Reims</city>
        <zip>51726</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Christophe Eymard, MD</last_name>
      <email>jc.eymard@reims.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital d'Instruction des Armées Bégin</name>
      <address>
        <city>Saint-Mandé</city>
        <zip>94160</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carole Helissey, MD</last_name>
      <phone>+33 (0)1 43 98 53 19</phone>
      <email>carolehelissey@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie Lucien Neuwirth</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42271</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aline Guillot, MD</last_name>
      <phone>+33 (0)4 77 97 70 34</phone>
      <email>aline.guillot@icloire.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yann Neuzillet, MD</last_name>
      <email>y.neuzillet@hopital-foch.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de Lorraine</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54519</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Egea, MD</last_name>
      <email>j.egea@nancy.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinik Hirslanden Aarau</name>
      <address>
        <city>Aarau</city>
        <zip>5001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Baden</name>
      <address>
        <city>Baden</city>
        <zip>5404</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Bellinzona Istituto Oncologico</name>
      <address>
        <city>Bellinzona</city>
        <zip>6500</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Baselland</name>
      <address>
        <city>Bruderholz</city>
        <zip>4101</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Kantansspital Graubündern</name>
      <address>
        <city>Chur</city>
        <zip>7000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Münsterlingen</name>
      <address>
        <city>Münsterlingen</city>
        <zip>8596</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St.Gallen</name>
      <address>
        <city>Saint Gallen</city>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stadtspital Triemli</name>
      <address>
        <city>Zürich</city>
        <zip>8063</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location_countries>
    <country>France</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03819101
org study id: 2017-004639-35
secondary id: 2017/2601
nct id: NCT03819101
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a 2x2 factorial randomized, multicenter, international, open phase III trial.

      The primary objective is to evaluate the benefit of acetylsalicylic acid and atorvastatin on
      overall survival (OS) (main endpoint) for patients with castrate-resistant prostate cancer
      starting first line treatment for CRPC
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: This is a 2x2 factorial randomized, multicenter, international, open phase III trial
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS)
time frame: OS will be calculated from the date of randomization to the date of death up to 15 years
arm group label: Arm A
arm group type: No Intervention
description: Standard of Care (SOC) for CRPC
arm group label: Arm B
arm group type: Experimental
description: SOC + acetylsalicylic acid 100 mg daily
arm group label: Arm C
arm group type: Experimental
description: SOC + atorvastatin 80 mg daily
arm group label: Arm D
arm group type: Experimental
description: SOC + acetylsalicylic acid 100 mg daily + atorvastatin 8
intervention type: Drug
intervention name: Acetylsalicylic acid
description: 100mg
arm group label: Arm B
arm group label: Arm D
intervention type: Drug
intervention name: Atorvastatin
description: 80 mg
arm group label: Arm C
arm group label: Arm D
criteria: 
gender: Male
gender based: Yes
gender description: Prostate cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karim Fizazi, MD, PhD
phone: +33 (0)1 42 11 43 17
email: karim.fizazi@gustaveroussy.fr
last name: Gwenael Le Teuff
phone: +33 (0)1 42 11 49 55
email: gwenael.leteuff@gustaveroussy.fr
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
country: France
country: Switzerland
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Aspirin
mesh term: Atorvastatin
sharing ipd: Undecided