<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/NCT03767244</url>
  </required_header>
  <id_info>
    <org_study_id>CR108535</org_study_id>
    <secondary_id>56021927PCR3011</secondary_id>
    <secondary_id>2018-001746-34</secondary_id>
    <secondary_id>2023-506153-38-00</secondary_id>
    <nct_id>NCT03767244</nct_id>
  </id_info>
  <brief_title>A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy</brief_title>
  <acronym>PROTEUS</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if treatment with apalutamide plus androgen&#xD;
      deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node&#xD;
      dissection (pLND) in participants with high-risk localized or locally advanced prostate&#xD;
      cancer results in an improvement in pathological complete response (pCR) rate and&#xD;
      metastasis-free survival (MFS) as compared to placebo plus ADT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High-risk prostate cancer accounts for approximately 15 percent (%) of newly diagnosed&#xD;
      prostate cancers. A systemic therapy that eradicates micrometastatic disease is needed to&#xD;
      improve survival in high-risk participants undergoing RP with pLND. It is hypothesized that&#xD;
      androgen blockade prior to and after RP with pLND may improve outcomes for participants at&#xD;
      the highest risk for recurrence. This study is designed to evaluate if androgen blockade&#xD;
      administered prior to and after RP with pLND will increase the rate of pathological complete&#xD;
      response (pCR) and lead to better overall outcomes. ERLEADA (apalutamide, also known as&#xD;
      JNJ-56021927 and ARN-509) is an orally available, non-steroidal small molecule, which acts as&#xD;
      a potent and selective antagonist of the androgen receptor (AR), currently being developed&#xD;
      for the treatment of prostate cancer. The study includes screening phase (approximately up to&#xD;
      35 days before randomization), treatment phase (the planned Treatment Phase will include a&#xD;
      total of 12 treatment cycles of apalutamide or placebo; 6 cycles prior to RP with pLND (Cycle&#xD;
      1 through Cycle 6) and 6 cycles after RP with pLND (Cycle 7 through Cycle 12). Cycle 1 Day 1&#xD;
      will start within 3 days after randomization) and follow-up phase. The end of study (study&#xD;
      completion) is defined as last participant assessment at study site with approximate study&#xD;
      duration of 8 years. Participants will undergo efficacy, pharmacokinetics and biomarker&#xD;
      evaluations. The safety will be monitored throughout the study. An open-label sub-study&#xD;
      comparing apalutamide plus ADT before and after RP with pLND with standard of care treatment&#xD;
      will be initiated at selected sites upon notification by the sponsor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 11, 2019</start_date>
  <completion_date type="Anticipated">April 7, 2027</completion_date>
  <primary_completion_date type="Anticipated">April 22, 2024</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>Percentage of Participants with Pathologic complete response (pCR)</measure>
    <time_frame>Approximately 4 years</time_frame>
    <description>pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metastasis-Free Survival (MFS)</measure>
    <time_frame>Up to 7 years and 5 months</time_frame>
    <description>MFS is defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis evaluated by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prostate Specific Antigen (PSA)-Free Survival</measure>
    <time_frame>Approximately 4 years</time_frame>
    <description>PSA-free survival with testosterone recovery defined as the time from randomization to the first detectable serum PSA level with recovered testosterone levels after undetectable PSA post-radical prostatectomy with pelvic lymph node dissection or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event Free Survival (EFS)</measure>
    <time_frame>Up to 7 years and 5 months</time_frame>
    <description>EFS defined as time from randomization to any of the following events: biochemical failure (BCF); or local or regional recurrence by BICR or histopathological assessment; or distant metastasis by BICR or histopathological assessment; or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Subsequent First Treatments (TTST-1)</measure>
    <time_frame>Up to 7 years and 5 months</time_frame>
    <description>TTST-1 is defined as the time from randomization to the date of first subsequent therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Distant Metastasis (TTDM)</measure>
    <time_frame>Up to 7 years and 5 months</time_frame>
    <description>TTDM is defined as the time from the date of enrollment until the first date of distant metastasis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MFS Based on Conventional Imaging</measure>
    <time_frame>Up to 7 years and 5 months</time_frame>
    <description>MFS based on conventional imaging, defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis on CT/MRI and bone scan by radiology BICR, pathologic finding of distant metastasis, or death from any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>Up to 30 days after last dose of study drug (Approximately 8 years)</time_frame>
    <description>An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to 30 days after last dose of study drug (Approximately 8 years)</time_frame>
    <description>Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Vital Signs Abnormalities as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to 30 days after last dose of study drug (Approximately 8 years)</time_frame>
    <description>Number of participants with vital signs (including body temperature, heart rate, respiratory rate, and blood pressure) abnormalities will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Physical Examinations Abnormalities as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to 30 days after last dose of study drug (Approximately 8 years)</time_frame>
    <description>Number of participants with physical examinations (including general appearance of the participant, height, weight, and examination of the skin, ears, nose, throat, lungs, heart, abdomen, extremities, musculoskeletal system, lymphatic system, and nervous system) abnormalities will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Treatment Compliance Rate</measure>
    <time_frame>Up to 30 days after last dose of study drug (Approximately 8 years)</time_frame>
    <description>Number of participants who are complaint with study treatment will be assessed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Apalutamide + ADT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + ADT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apalutamide</intervention_name>
    <description>Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.</description>
    <arm_group_label>Apalutamide + ADT</arm_group_label>
    <other_name>JNJ-56021927</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Androgen Deprivation Therapy (ADT)</intervention_name>
    <description>Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter [ng/dL]).</description>
    <arm_group_label>Apalutamide + ADT</arm_group_label>
    <arm_group_label>Placebo + ADT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive matching placebo oral tablets daily.</description>
    <arm_group_label>Placebo + ADT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          -  High-risk disease defined by a total Gleason Sum Score greater than equal to (&gt;=) 4+3&#xD;
             (=Grade Groups [GG] 3 5) and &gt;=1 of the following 4 criteria: a) Any combination of&#xD;
             Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in &gt;= 6 systematic cores&#xD;
             (with &gt;=1 core Gleason Score 8 [4+4 or 5+3] included); b) Any combination of Gleason&#xD;
             Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in &gt;=3 systematic cores and&#xD;
             Prostate-specific antigen (PSA) &gt;=20 ng/mL (with &gt;= 1 core Gleason Score 8 [4+4 or&#xD;
             5+3] included); c) Gleason Score &gt;=9 (=GG 5) in at least 1 systematic or targeted&#xD;
             core; d) At least 2 systematic or targeted cores with continuous Gleason Score &gt;=8&#xD;
             (=GG 4), each with &gt; 80 percent (%) involvement&#xD;
&#xD;
          -  Candidate for radical prostatectomy with pelvic lymph node dissection as per the&#xD;
             investigator&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1&#xD;
&#xD;
          -  Contraceptive use by male participants (and female partners of male participants&#xD;
             enrolled in the study who are of childbearing potential or are pregnant) should be&#xD;
             consistent with local regulations regarding the use of contraceptive methods for&#xD;
             participants participating in clinical studies&#xD;
&#xD;
          -  Able to receive androgen deprivation therapy (ADT) for at least 13 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease&#xD;
             below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of&#xD;
             distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal&#xD;
             disease (clinical N stage; N1 versus N0) will be assessed by central radiological&#xD;
             review. Participants are considered eligible only if the central radiological review&#xD;
             confirms clinical stage M0&#xD;
&#xD;
          -  (a) Prior treatment with androgen receptor antagonists; (b) Treatment with&#xD;
             gonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF)&#xD;
             signature&#xD;
&#xD;
          -  History of prior systemic or local therapy for prostate cancer, including pelvic&#xD;
             radiation for prostate cancer&#xD;
&#xD;
          -  Use of any investigational agent less than or equals to (&lt;=)4 weeks prior to&#xD;
             randomization or any therapeutic procedure for prostate cancer at any time&#xD;
&#xD;
          -  Major surgery &lt;=4 weeks prior to randomization&#xD;
&#xD;
          -  Any of the following within 12 months prior to first dose of study drug: severe or&#xD;
             unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial&#xD;
             or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident&#xD;
             including transient ischemic attacks), or clinically significant ventricular&#xD;
             arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated&#xD;
             deep vein thrombosis is not considered exclusionary&#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>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Study Contact</last_name>
    <phone>844-434-4210</phone>
    <email>Participate-In-This-Study@its.jnj.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>UC San Diego Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Urology Center of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Colorado Clinical Research</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stamford Hospital</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06904</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Urology Specialists LLC</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33002</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Division Of Hematology/oncology</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute at Baptist Health / Baptist Health Medical Group</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Emory University - Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322-1013</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ochsner LSU Health Shreveport - Regional Urology</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beth Isreal Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Michigan Institute of Urology, PC</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48084</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Urology Cancer Center, PC</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Albany Medical College</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Great Lakes Physician PC d/b/a Western New York Urology Associates</name>
      <address>
        <city>Cheektowaga</city>
        <state>New York</state>
        <zip>14225</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Duke University School of Medicine</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Medication Management, LLC</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Carolina Urology Partners, PLLC</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Cleveland VA Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Oklahoma City VAMC</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>MidLantic Urology</name>
      <address>
        <city>Bala-Cynwyd</city>
        <state>Pennsylvania</state>
        <zip>19004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29403</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ralph H. Johnson Veterans Affairs Medical Center</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Greenville Health</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Carolina Urologic Research Center</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>VA North Texas Health Care System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Virginia Urology</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Urology of Virginia, PLCC</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23462</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CAMC Memorial Hospital, Charleston Area Medical Center Physicians</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Aleman</name>
      <address>
        <city>Caba</city>
        <zip>1118</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Italiano de Buenos Aires</name>
      <address>
        <city>Ciudad Autonoma de</city>
        <zip>C1199ABB</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centro Urologico Profesor Bengio</name>
      <address>
        <city>Cordoba</city>
        <zip>X5000KPH</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uroclinica</name>
      <address>
        <city>Mendoza</city>
        <zip>5500</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Clinica Mayo de UMCB</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <zip>4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Epworth Eastern Hospital</name>
      <address>
        <city>Box Hill</city>
        <zip>3128q</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Hospital Sydney</name>
      <address>
        <city>Darlinghurst</city>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Austin Health</name>
      <address>
        <city>Heidelberg</city>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Australian Urology Associates Pty Ltd</name>
      <address>
        <city>Malvern</city>
        <zip>3144</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northern Cancer Institute</name>
      <address>
        <city>St Leonards</city>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Australian Clinical Trials - SAN Clinic</name>
      <address>
        <city>Wahroonga</city>
        <zip>2076</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Woolloongabba</city>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge</name>
      <address>
        <city>Goiania</city>
        <zip>74605-070</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda</name>
      <address>
        <city>Ijui</city>
        <zip>98700-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Liga Norte Riograndense Contra O Cancer</name>
      <address>
        <city>Natal</city>
        <zip>59075-740</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Irmandade Santa Casa de Misericordia de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90020-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universidade do Estado do Rio de Janeiro - UERJ</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20551-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Associacao Umane</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01232-910</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Instituto Do Cancer Brasil</name>
      <address>
        <city>Três Lagoas</city>
        <zip>79601-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Prostate Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2V 1P9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nova Scotia Health Authority</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Center</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Center</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University Health Network (UHN) Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHUM - Centre hospitalier universitaire de Montreal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Québec-Université Laval-Hôpital de l'Enfant-Jésus</name>
      <address>
        <city>Quebec</city>
        <zip>G1R 2J6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Hradec Kralove</name>
      <address>
        <city>Hradec Králove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Krajská nemocnice Liberec</name>
      <address>
        <city>Liberec</city>
        <zip>460 63</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uromedical Center s.r.o.</name>
      <address>
        <city>Olomouc</city>
        <zip>77200</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Plzen, Urologicka klinika</name>
      <address>
        <city>Plzen</city>
        <zip>305 99</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Thomayerova nemocnice</name>
      <address>
        <city>Praha 4</city>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vseobecna fakultni nemocnice v Praze</name>
      <address>
        <city>Praha</city>
        <zip>120 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHRU Besançon -Hôpital Jean Minjoz</name>
      <address>
        <city>Besançon Cedex</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Pellegrin CHU Bordeaux</name>
      <address>
        <city>Bordeaux N/a</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>APHP - Hopital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Edouard Herriot - CHU Lyon</name>
      <address>
        <city>Lyon cedex 03</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes hôtel-Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinique de la Croix du Sud</name>
      <address>
        <city>Quint-Fonsegrives</city>
        <zip>31130</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chu Rennes - Hopital Pontchaillou</name>
      <address>
        <city>Rennes Cedex</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse - Hôpital Rangueil</name>
      <address>
        <city>Toulouse Cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHRU Tours Hôpital Bretonneau</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum der RWTH Aachen</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer</name>
      <address>
        <city>Braunschweig</city>
        <zip>38126</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Prostata zentrum Nordwest</name>
      <address>
        <city>Gronau</city>
        <zip>48599</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum des Saarlandes</name>
      <address>
        <city>Homburg/Saar</city>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Koelnt</name>
      <address>
        <city>Koeln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig Holstein Campus Lübeck</name>
      <address>
        <city>Lubeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Ralf Eckert</name>
      <address>
        <city>Lutherstadt Eisleben</city>
        <zip>06295</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum St. Elisabeth Straubing GmbH</name>
      <address>
        <city>Straubing</city>
        <zip>94315</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kliniken Nordoberpfalz, Klinik für Urologie</name>
      <address>
        <city>Weiden/Opf</city>
        <zip>92637</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Praxisgemeinschaft f. Onkologie u. Urologie - Germany</name>
      <address>
        <city>Wilhelmshaven</city>
        <zip>26389</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asaf Harofe Medical Center</name>
      <address>
        <city>Beer Yaakov</city>
        <zip>60930</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Policlinico Abano Terme</name>
      <address>
        <city>Abano Terme</city>
        <zip>35031</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Generale Regionale F. Miulli</name>
      <address>
        <city>Acquaviva delle Fonti</city>
        <zip>70021</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ospedale di Bassano del Grappa</name>
      <address>
        <city>Bassano del Grappa</city>
        <zip>36061</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ASST Spedali Civili Brescia</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti</name>
      <address>
        <city>Chieti</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Careggi</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico</name>
      <address>
        <city>MIlano</city>
        <zip>20127</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinica di Urologia Policlinico di Modena - Università di Modena e reggio Emilia</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga</name>
      <address>
        <city>Orbassano</city>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universita Campus Bio-Medico di Roma</name>
      <address>
        <city>Roma</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori Regina Elena</name>
      <address>
        <city>Roma</city>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Sant Andrea</name>
      <address>
        <city>Roma</city>
        <zip>00189</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ospedale Molinette, AO Città della Salute e della Scienza di</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento</name>
      <address>
        <city>Verona</city>
        <zip>37126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Akita University Hospital</name>
      <address>
        <city>Akita</city>
        <zip>010-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chiba University Hospital</name>
      <address>
        <city>Chiba</city>
        <zip>260-8677</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chiba Cancer Center</name>
      <address>
        <city>Chuo-ku, Chiba-City,</city>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hakodate Goryokaku Hospital</name>
      <address>
        <city>Hakodate</city>
        <zip>040-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hirosaki University Hospital</name>
      <address>
        <city>Hirosaki</city>
        <zip>036-8203</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Kanazawa</city>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital</name>
      <address>
        <city>Kobe</city>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Saitama Medical Center</name>
      <address>
        <city>Koshigaya</city>
        <zip>343-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Kurume</city>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organizaiton Shikoku Cancer Center</name>
      <address>
        <city>Matsuyama</city>
        <zip>791-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kitasato University Hospital</name>
      <address>
        <city>Minami-Ku, Sagamihara-Shi</city>
        <zip>252-0375</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Miyazaki Hospital</name>
      <address>
        <city>Miyazaki</city>
        <zip>889-1692</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagano Municipal Hospital</name>
      <address>
        <city>Nagano</city>
        <zip>381-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital</name>
      <address>
        <city>Osaka-Sayama-shi</city>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
      <address>
        <city>Osaka</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Toho University Sakura Medical Center</name>
      <address>
        <city>Sakura</city>
        <zip>285-8741</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo-shi</city>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Iwate Medical University Hospital</name>
      <address>
        <city>Shiwa-gun</city>
        <zip>028-3695</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8421</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Yamaguchi University Hospital</name>
      <address>
        <city>Ube</city>
        <zip>755-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Medical Center</name>
      <address>
        <city>Yokohama</city>
        <zip>232-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hospital</name>
      <address>
        <city>Gwangju</city>
        <zip>61469</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>13605</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NKI-AVL, Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Catharinaziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis (St. Antonius Hospital)</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3430EM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Canisius-Wilhelmina Ziekenhuis</name>
      <address>
        <city>Nijmegen</city>
        <zip>6524 KD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Wielospecjalistyczny Zakład Opieki Zdrowotnej MSWiA w Bydgoszczy</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-015</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-094</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie</name>
      <address>
        <city>Koszalin</city>
        <zip>75-581</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pratia MCM Krakow</name>
      <address>
        <city>Krakow</city>
        <zip>30-727</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>City Clinic Sp. z o.o.</name>
      <address>
        <city>Warszawa</city>
        <zip>02-473</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia</name>
      <address>
        <city>Wrocław</city>
        <zip>53-413</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Altai Regional Oncology Dispensary</name>
      <address>
        <city>Barnaul</city>
        <zip>656049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454087</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Moscow City Clinical Hospital # 62</name>
      <address>
        <city>Moscow</city>
        <zip>125130</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hertzen Oncology Research Institute</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Oncology Dispensary</name>
      <address>
        <city>Omsk</city>
        <zip>644013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medical-sanitary unit 'Neftyanik'</name>
      <address>
        <city>Tyumen</city>
        <zip>625000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vologda Regional Oncological Dispensary</name>
      <address>
        <city>Vologda</city>
        <zip>160012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. A Coruña</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Vall D Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>8035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hosp. Puerta Del Mar</name>
      <address>
        <city>Cadiz</city>
        <zip>11009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hosp. Gral. Univ. De Castellon</name>
      <address>
        <city>Castellón</city>
        <zip>12004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hosp. de Jerez de La Frontera</name>
      <address>
        <city>Jerez de la Frontera</city>
        <zip>11407</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Ramon Y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fund. Hosp. de Manacor</name>
      <address>
        <city>Manacor</city>
        <zip>07500</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hosp. Virgen de La Victoria</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hosp. Virgen Del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Inst. Valenciano de Oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hosp. Clinico Univ. de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tungs' Taichung MetroHarbor Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>435</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chi Mei Medical Center - Yong Kang</name>
      <address>
        <city>Tainan</city>
        <zip>710</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital.</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Southmead Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ninewells Hospital</name>
      <address>
        <city>Dundee</city>
        <zip>DD2 1UB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University College London</name>
      <address>
        <city>London</city>
        <zip>WC1E 6BT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital</name>
      <address>
        <city>Preston</city>
        <zip>PR2 9HT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>MidYorkshire NHS Trust</name>
      <address>
        <city>Wakefield</city>
        <zip>WF1 4DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>China</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 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>Androgens</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sharing policy of the Janssen Pharmaceutical companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials/transparency.&#xD;
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu</ipd_description>
    <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
  </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/NCT03767244
org study id: CR108535
secondary id: 56021927PCR3011
secondary id: 2018-001746-34
secondary id: 2023-506153-38-00
nct id: NCT03767244
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine if treatment with apalutamide plus androgen
      deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node
      dissection (pLND) in participants with high-risk localized or locally advanced prostate
      cancer results in an improvement in pathological complete response (pCR) rate and
      metastasis-free survival (MFS) as compared to placebo plus ADT.
High-risk prostate cancer accounts for approximately 15 percent (%) of newly diagnosed
      prostate cancers. A systemic therapy that eradicates micrometastatic disease is needed to
      improve survival in high-risk participants undergoing RP with pLND. It is hypothesized that
      androgen blockade prior to and after RP with pLND may improve outcomes for participants at
      the highest risk for recurrence. This study is designed to evaluate if androgen blockade
      administered prior to and after RP with pLND will increase the rate of pathological complete
      response (pCR) and lead to better overall outcomes. ERLEADA (apalutamide, also known as
      JNJ-56021927 and ARN-509) is an orally available, non-steroidal small molecule, which acts as
      a potent and selective antagonist of the androgen receptor (AR), currently being developed
      for the treatment of prostate cancer. The study includes screening phase (approximately up to
      35 days before randomization), treatment phase (the planned Treatment Phase will include a
      total of 12 treatment cycles of apalutamide or placebo; 6 cycles prior to RP with pLND (Cycle
      1 through Cycle 6) and 6 cycles after RP with pLND (Cycle 7 through Cycle 12). Cycle 1 Day 1
      will start within 3 days after randomization) and follow-up phase. The end of study (study
      completion) is defined as last participant assessment at study site with approximate study
      duration of 8 years. Participants will undergo efficacy, pharmacokinetics and biomarker
      evaluations. The safety will be monitored throughout the study. An open-label sub-study
      comparing apalutamide plus ADT before and after RP with pLND with standard of care treatment
      will be initiated at selected sites upon notification by the sponsor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants with Pathologic complete response (pCR)
time frame: Approximately 4 years
description: pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter.
measure: Metastasis-Free Survival (MFS)
time frame: Up to 7 years and 5 months
description: MFS is defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis evaluated by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
measure: Prostate Specific Antigen (PSA)-Free Survival
time frame: Approximately 4 years
description: PSA-free survival with testosterone recovery defined as the time from randomization to the first detectable serum PSA level with recovered testosterone levels after undetectable PSA post-radical prostatectomy with pelvic lymph node dissection or death, whichever occurs first.
measure: Event Free Survival (EFS)
time frame: Up to 7 years and 5 months
description: EFS defined as time from randomization to any of the following events: biochemical failure (BCF); or local or regional recurrence by BICR or histopathological assessment; or distant metastasis by BICR or histopathological assessment; or death.
measure: Time to Subsequent First Treatments (TTST-1)
time frame: Up to 7 years and 5 months
description: TTST-1 is defined as the time from randomization to the date of first subsequent therapy.
measure: Time to Distant Metastasis (TTDM)
time frame: Up to 7 years and 5 months
description: TTDM is defined as the time from the date of enrollment until the first date of distant metastasis.
measure: MFS Based on Conventional Imaging
time frame: Up to 7 years and 5 months
description: MFS based on conventional imaging, defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis on CT/MRI and bone scan by radiology BICR, pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
measure: Number of Participants with Adverse Events
time frame: Up to 30 days after last dose of study drug (Approximately 8 years)
description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
measure: Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability
time frame: Up to 30 days after last dose of study drug (Approximately 8 years)
description: Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing.
measure: Number of Participants with Vital Signs Abnormalities as a Measure of Safety and Tolerability
time frame: Up to 30 days after last dose of study drug (Approximately 8 years)
description: Number of participants with vital signs (including body temperature, heart rate, respiratory rate, and blood pressure) abnormalities will be reported.
measure: Number of Participants with Physical Examinations Abnormalities as a Measure of Safety and Tolerability
time frame: Up to 30 days after last dose of study drug (Approximately 8 years)
description: Number of participants with physical examinations (including general appearance of the participant, height, weight, and examination of the skin, ears, nose, throat, lungs, heart, abdomen, extremities, musculoskeletal system, lymphatic system, and nervous system) abnormalities will be reported.
measure: Number of Participants with Treatment Compliance Rate
time frame: Up to 30 days after last dose of study drug (Approximately 8 years)
description: Number of participants who are complaint with study treatment will be assessed.
arm group label: Apalutamide + ADT
arm group type: Experimental
description: Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment.
arm group label: Placebo + ADT
arm group type: Experimental
description: Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment.
intervention type: Drug
intervention name: Apalutamide
description: Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
arm group label: Apalutamide + ADT
other name: JNJ-56021927
intervention type: Drug
intervention name: Androgen Deprivation Therapy (ADT)
description: Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter [ng/dL]).
arm group label: Apalutamide + ADT
arm group label: Placebo + ADT
intervention type: Drug
intervention name: Placebo
description: Participants will receive matching placebo oral tablets daily.
arm group label: Placebo + ADT
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
last name: Study Contact
phone: 844-434-4210
email: Participate-In-This-Study@its.jnj.com
facility: 
status: Recruiting
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status: Completed
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status: Recruiting
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status: Recruiting
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status: Completed
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status: Recruiting
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status: Recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
facility: 
status: Completed
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Active, not recruiting
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status: Completed
facility: 
status: Active, not recruiting
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status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
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status: Recruiting
country: Argentina
country: Australia
country: Brazil
country: Canada
country: Czechia
country: France
country: Germany
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: Poland
country: Russian Federation
country: Spain
country: Taiwan
country: United Kingdom
country: United States
country: China
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Androgens
sharing ipd: Yes
ipd description: The data sharing policy of the Janssen Pharmaceutical companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
ipd url: https://www.janssen.com/clinical-trials/transparency