<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/NCT03809000</url>
  </required_header>
  <id_info>
    <org_study_id>RTOG 3506</org_study_id>
    <secondary_id>STEEL</secondary_id>
    <nct_id>NCT03809000</nct_id>
  </id_info>
  <brief_title>A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery</brief_title>
  <acronym>STEEL</acronym>
  <official_title>STEEL: A Randomized Phase II Trial of Salvage Radiotherapy With Standard vs Enhanced Androgen Deprivation Therapy (With Enzalutamide) in Patients With Post-Prostatectomy PSA Recurrences With Aggressive Disease Features</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RTOG Foundation, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>RTOG Foundation, Inc.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive&#xD;
      disease features will receive salvage radiation therapy and standard androgen deprivation&#xD;
      therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free&#xD;
      survival when enhanced ADT is used compared to standard ADT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      To determine whether, in men with post-prostatectomy PSA (prostate specific antigen)&#xD;
      recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced&#xD;
      androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog,&#xD;
      will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Anticipated">September 15, 2029</completion_date>
  <primary_completion_date type="Actual">April 7, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>From the date of randomization to the date of progression, death from any cause or last known follow-up date, assessed up to 5 years.</time_frame>
    <description>The time from the date of randomization to the date of progression, death from any cause or last known follow-up date.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">188</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Salvage Radiation Therapy + Standard ADT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog with or without 1-4 months of bicalutamide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salvage Radiation Therapy + Enhanced ADT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog + 24 months of enzalutamide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>Radiation Therapy</description>
    <arm_group_label>Salvage Radiation Therapy + Enhanced ADT</arm_group_label>
    <arm_group_label>Salvage Radiation Therapy + Standard ADT</arm_group_label>
    <other_name>RT</other_name>
    <other_name>Three-Dimensional Conformal Radiation Therapy (3D-CRT)</other_name>
    <other_name>Intensity-Modulated Radiation Therapy (IMRT)</other_name>
    <other_name>Image-Guided Radiation Therapy (IGRT)</other_name>
    <other_name>Radiotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide</intervention_name>
    <description>Anti-androgen</description>
    <arm_group_label>Salvage Radiation Therapy + Enhanced ADT</arm_group_label>
    <other_name>Xtandi®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bicalutamide</intervention_name>
    <description>Anti-androgen</description>
    <arm_group_label>Salvage Radiation Therapy + Standard ADT</arm_group_label>
    <other_name>Casodex®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GnRH analog</intervention_name>
    <description>Anti-androgen</description>
    <arm_group_label>Salvage Radiation Therapy + Enhanced ADT</arm_group_label>
    <arm_group_label>Salvage Radiation Therapy + Standard ADT</arm_group_label>
    <other_name>Gonadotropin-releasing hormone analog</other_name>
    <other_name>Lupron®</other_name>
    <other_name>leuprolide acetate</other_name>
    <other_name>goserelin acetate</other_name>
    <other_name>Eligard™</other_name>
    <other_name>Viadur™</other_name>
    <other_name>Zoldaex®</other_name>
    <other_name>Trelstar®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically (histologically) proven adenocarcinoma confirmed by prostatectomy&#xD;
             performed within 10 years prior to registration and any type of radical prostatectomy&#xD;
             is permitted, including retropubic, perineal, laparoscopic or robotically assisted.&#xD;
&#xD;
          -  PSA level (≥ 0.2 ng/mL) within 120 days prior to registration. Patients must have a&#xD;
             PSA ≥ 0.2 ng/mL prior to starting ADT. For patients being followed by an&#xD;
             ultrasensitive PSA assay, a serum PSA concentration of ≥ 0.10 ng/mL will be considered&#xD;
             eligible.&#xD;
&#xD;
          -  GnRH analog may be started no more than 42 days prior study entry.&#xD;
&#xD;
          -  Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 90 days&#xD;
             prior to registration.&#xD;
&#xD;
          -  Platelet count ≥ 75,000 x 10^9/µL independent of transfusion and/or growth factors&#xD;
             within 90 days prior to registration.&#xD;
&#xD;
          -  At least 1 of the following aggressive features:&#xD;
&#xD;
               -  Gleason score of 8-10 (note any Gleason score is eligible)&#xD;
&#xD;
               -  Seminal vesicle invasion (SVI) (note any pT stage [AJCC v8.0] is eligible but a&#xD;
                  pT stage&#xD;
&#xD;
                  ≥ pT3b is considered aggressive)&#xD;
&#xD;
               -  Locoregional node involvement at radical prostatectomy (pN1)&#xD;
&#xD;
               -  Persistently elevated PSA post-RP nadir (PEPP) defined as PSA &gt; 0.1 ng/mL after&#xD;
                  radical prostatectomy&#xD;
&#xD;
               -  PSA ≥ 0.7 ng/mL&#xD;
&#xD;
          -  Serum albumin ≥ 3.0 g/dL within 90 days prior to registration&#xD;
&#xD;
          -  GFR ≥35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine&#xD;
             creatinine within 90 days prior to registration.&#xD;
&#xD;
          -  Serum total bilirubin ≤1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total&#xD;
             bilirubin is &gt;1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin&#xD;
             is ≤1.5 × ULN, subject is eligible) within 90 days prior to registration.&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) &lt;2.5 × ULN within&#xD;
             90 days prior to registration.&#xD;
&#xD;
          -  History and physical with ECOG Performance Status 0-1 or within 90 days prior to&#xD;
             registration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Definitive clinical or radiologic evidence of metastatic disease with the exception of&#xD;
             locoregional lymph nodes.&#xD;
&#xD;
          -  Prior invasive malignancy (except non-melanomatous skin cancer carcinoma in situ of&#xD;
             the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely&#xD;
             resected melanoma) unless disease free for a minimum of 2 years).&#xD;
&#xD;
          -  Prior systemic chemotherapy for the study cancer. Note: prior chemotherapy for a&#xD;
             different cancer is allowable.&#xD;
&#xD;
          -  Prior radiotherapy to the region of the study cancer that would result in overlap of&#xD;
             radiation therapy fields.&#xD;
&#xD;
          -  History of any of the following:&#xD;
&#xD;
               -  Documented inflammatory bowel disease&#xD;
&#xD;
               -  Transmural myocardial infarction within the last 4 months prior to registration.&#xD;
&#xD;
               -  New York Heart Association Functional Classification III/IV within 4 months prior&#xD;
                  to registration.&#xD;
&#xD;
               -  Unstable angina and/or congestive heart failure requiring hospitalization within&#xD;
                  the last 4 months prior to registration&#xD;
&#xD;
               -  History of loss of consciousness or transient ischemic attack within 12 months&#xD;
                  prior to randomization&#xD;
&#xD;
               -  History of seizure disorder or condition that may predispose to seizure (e.g.&#xD;
                  prior cortical stroke or significant brain trauma)&#xD;
&#xD;
               -  History of uncontrolled hypertension defined as a sustained systolic blood&#xD;
                  pressure in excess of 150 mmHg or a sustained diastolic blood pressure in excess&#xD;
                  of 90 mmHg despite optimized antihypertensive therapy.&#xD;
&#xD;
               -  History of repeated falls and fractures over the past 12 months that in the&#xD;
                  opinion of the treating investigator would put the patient at risk for poor bone&#xD;
                  outcomes from androgen receptor targeted therapy&#xD;
&#xD;
          -  Known gastrointestinal disorder affecting absorption of oral medications.&#xD;
&#xD;
          -  Active uncontrolled infection defined as an identified infectious condition that&#xD;
             requires active therapy that has not yet been completed.&#xD;
&#xD;
          -  HIV positive patients with CD4 count &lt; 200 cells/microliter within 30 days prior to&#xD;
             registration OR HIV patients under treatment with highly active antiretroviral therapy&#xD;
             (HAART) within 30 days prior to registration regardless of CD4 count. Note: HIV&#xD;
             testing is not required for eligibility for this protocol as it is self-reported. This&#xD;
             exclusion criterion is necessary because the treatments involved in this protocol may&#xD;
             be immunosuppressive and/or interact with HAART.&#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>Edwin Posadas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RTOG Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hiram Gay, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RTOG Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Center for Cancer Care - Gilbert</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85297</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Center for Cancer Care - Peoria</name>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <zip>85381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Center for Cancer Care - Phoenix</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Center for Cancer Care - Scottsdale East</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Center for Cancer Care - Scottsdale North</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Center for Cancer Care - Surprise</name>
      <address>
        <city>Surprise</city>
        <state>Arizona</state>
        <zip>85374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marin Cancer Care, Inc.</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marin Health Medical Center</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>USC Medical Center - Los Angeles County</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Roseville Radiation Oncology Center</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutter Roseville Medical Center</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutter Medical Center Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley View Hospital Cancer Center</name>
      <address>
        <city>Glenwood Springs</city>
        <state>Colorado</state>
        <zip>81601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Science Center</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdventHealth Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nancy N. &amp; J.C. Lewis Cancer &amp; Research Pavilion</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Decatur Memorial Hospital</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crossroads Cancer Center</name>
      <address>
        <city>Effingham</city>
        <state>Illinois</state>
        <zip>62401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas University Cancer Center Overland Park</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas University Cancer Center Westwood</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Jefferson General Hospital</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LSU Healthcare Network/Metairie Multi-Specialty Clinic</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Cancer Treatment Center - Bath</name>
      <address>
        <city>Bath</city>
        <state>Maine</state>
        <zip>04530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waldo Count General Hospital - Belfast</name>
      <address>
        <city>Belfast</city>
        <state>Maine</state>
        <zip>04915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Health/SMHC Cancer Care and Blood Disorders-Biddeford</name>
      <address>
        <city>Biddeford</city>
        <state>Maine</state>
        <zip>04005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Health/Stephens Memorial - Norway</name>
      <address>
        <city>Norway</city>
        <state>Maine</state>
        <zip>04268</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center - Bramhall S Portland</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penobscot Bay Medical Center - Rockport</name>
      <address>
        <city>Rockport</city>
        <state>Maine</state>
        <zip>04856</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Health CC of York County - Sanford</name>
      <address>
        <city>Sanford</city>
        <state>Maine</state>
        <zip>04073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Health/SMHCancer Care and Blood Disorders - Sanford</name>
      <address>
        <city>Sanford</city>
        <state>Maine</state>
        <zip>04073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Cancer Center - Scarborough Campus</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Partners - South Portland</name>
      <address>
        <city>South Portland</city>
        <state>Maine</state>
        <zip>04106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute - Bloomfield</name>
      <address>
        <city>Bloomfield</city>
        <state>Michigan</state>
        <zip>48302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology MHP - Clarkston</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute - Clarkston</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital - Dearborn</name>
      <address>
        <city>Dearborn</city>
        <state>Michigan</state>
        <zip>48124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne State/Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology MHP - Farmington</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute - Flint</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singh and Arora Hematology Oncology PC</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute - Greater Lansing</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid-Michigan Physicians - Lansing</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute - Lapeer Region</name>
      <address>
        <city>Lapeer</city>
        <state>Michigan</state>
        <zip>48446</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology MHP - Macomb</name>
      <address>
        <city>Macomb</city>
        <state>Michigan</state>
        <zip>48044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology MHP - Madison Heights</name>
      <address>
        <city>Madison Heights</city>
        <state>Michigan</state>
        <zip>48071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute - Macomb</name>
      <address>
        <city>Mount Clemens</city>
        <state>Michigan</state>
        <zip>48043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute - Central Michigan</name>
      <address>
        <city>Mount Pleasant</city>
        <state>Michigan</state>
        <zip>48858</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute - Owosso</name>
      <address>
        <city>Owosso</city>
        <state>Michigan</state>
        <zip>48867</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute - Northern Michigan</name>
      <address>
        <city>Petoskey</city>
        <state>Michigan</state>
        <zip>49770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Cancer Institute - Port Huron</name>
      <address>
        <city>Port Huron</city>
        <state>Michigan</state>
        <zip>48060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital - Royal Oak</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital - Troy</name>
      <address>
        <city>Sterling Heights</city>
        <state>Michigan</state>
        <zip>48314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology MHP - Troy</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital</name>
      <address>
        <city>Coon Rapids</city>
        <state>Minnesota</state>
        <zip>55433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology PA - Maplewood</name>
      <address>
        <city>Maplewood</city>
        <state>Minnesota</state>
        <zip>55109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coborn Cancer Center</name>
      <address>
        <city>Saint Cloud</city>
        <state>Minnesota</state>
        <zip>56303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthPartners, Inc.</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regions Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas University Cancer Center North</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas University Cancer Center Lee's Summit</name>
      <address>
        <city>Lee's Summit</city>
        <state>Missouri</state>
        <zip>64064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exeter Hospital</name>
      <address>
        <city>Exeter</city>
        <state>New Hampshire</state>
        <zip>03833</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Physicians at Oneida</name>
      <address>
        <city>Oneida</city>
        <state>New York</state>
        <zip>13421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upstate Cancer Center Radiation Oncology at Oneida</name>
      <address>
        <city>Oneida</city>
        <state>New York</state>
        <zip>13421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Physicians at Oswego</name>
      <address>
        <city>Oswego</city>
        <state>New York</state>
        <zip>13126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upstate Cancer Radiation Oncology at Oswego</name>
      <address>
        <city>Oswego</city>
        <state>New York</state>
        <zip>13126</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Upstate Cancer Center at Hill Radiation Oncology</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNC Rex Cancer Center</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rex Cancer Center of Wakefield</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WellSpan Health - Ephrata Cancer Center</name>
      <address>
        <city>Ephrata</city>
        <state>Pennsylvania</state>
        <zip>17522</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WellSpan Health - Adams Cancer Center</name>
      <address>
        <city>Gettysburg</city>
        <state>Pennsylvania</state>
        <zip>17325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WellSpan Health - Sechler Family Cancer Center</name>
      <address>
        <city>Lebanon</city>
        <state>Pennsylvania</state>
        <zip>17402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center - Shadyside Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WellSpan Health - York Hospital</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gibbs Cancer Center - Pelham</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spartanburg Medical Center</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern/Simmons Cancer Center - Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Fork Hospital</name>
      <address>
        <city>American Fork</city>
        <state>Utah</state>
        <zip>84003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedar City Hospital</name>
      <address>
        <city>Cedar City</city>
        <state>Utah</state>
        <zip>84721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Logan Regional Medical Center</name>
      <address>
        <city>Logan</city>
        <state>Utah</state>
        <zip>84341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utah Valley Regional Medical Center</name>
      <address>
        <city>Provo</city>
        <state>Utah</state>
        <zip>84604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dixie Regional Medical Center</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center/Norris Cancer Ctr. - St. Johnsbury</name>
      <address>
        <city>Saint Johnsbury</city>
        <state>Vermont</state>
        <zip>05819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Cancer Institute at Sentara CarePlex Hospital</name>
      <address>
        <city>Hampton</city>
        <state>Virginia</state>
        <zip>23666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Norfolk General Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Virginia Beach General Hospital</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspirus Langlade Hospital</name>
      <address>
        <city>Antigo</city>
        <state>Wisconsin</state>
        <zip>54409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Cancer Center Johnson Creek</name>
      <address>
        <city>Johnson Creek</city>
        <state>Wisconsin</state>
        <zip>53038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Hospital and Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert Menomonee Falls Hospital</name>
      <address>
        <city>Menomonee Falls</city>
        <state>Wisconsin</state>
        <zip>53051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert Hospital &amp; the Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drexel Town Square</name>
      <address>
        <city>Oak Creek</city>
        <state>Wisconsin</state>
        <zip>53154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspirus Regional Cancer Center</name>
      <address>
        <city>Wausau</city>
        <state>Wisconsin</state>
        <zip>54401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert West Bend Hospital</name>
      <address>
        <city>West Bend</city>
        <state>Wisconsin</state>
        <zip>53095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspirus Cancer Care - Wisconsin Rapids</name>
      <address>
        <city>Wisconsin Rapids</city>
        <state>Wisconsin</state>
        <zip>54494</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Quebec - L'Hotel-Dieu de Quebec</name>
      <address>
        <city>Québec City</city>
        <state>Quebec</state>
        <zip>G1R 2J6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke-Fleurimont</name>
      <address>
        <city>Sherbrooke</city>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>June 1, 2023</last_update_submitted>
  <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Post-prostatectomy</keyword>
  <keyword>Enzalutamide</keyword>
  <keyword>STEEL</keyword>
  <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>Leuprolide</mesh_term>
    <mesh_term>Goserelin</mesh_term>
    <mesh_term>Bicalutamide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03809000
org study id: RTOG 3506
secondary id: STEEL
nct id: NCT03809000
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive
      disease features will receive salvage radiation therapy and standard androgen deprivation
      therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free
      survival when enhanced ADT is used compared to standard ADT.
PRIMARY OBJECTIVE:

      To determine whether, in men with post-prostatectomy PSA (prostate specific antigen)
      recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced
      androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog,
      will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival (PFS)
time frame: From the date of randomization to the date of progression, death from any cause or last known follow-up date, assessed up to 5 years.
description: The time from the date of randomization to the date of progression, death from any cause or last known follow-up date.
arm group label: Salvage Radiation Therapy + Standard ADT
arm group type: Active Comparator
description: Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog with or without 1-4 months of bicalutamide.
arm group label: Salvage Radiation Therapy + Enhanced ADT
arm group type: Experimental
description: Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog + 24 months of enzalutamide.
intervention type: Radiation
intervention name: Radiation Therapy
description: Radiation Therapy
arm group label: Salvage Radiation Therapy + Enhanced ADT
arm group label: Salvage Radiation Therapy + Standard ADT
other name: RT
other name: Three-Dimensional Conformal Radiation Therapy (3D-CRT)
other name: Intensity-Modulated Radiation Therapy (IMRT)
other name: Image-Guided Radiation Therapy (IGRT)
other name: Radiotherapy
intervention type: Drug
intervention name: Enzalutamide
description: Anti-androgen
arm group label: Salvage Radiation Therapy + Enhanced ADT
other name: Xtandi®
intervention type: Drug
intervention name: Bicalutamide
description: Anti-androgen
arm group label: Salvage Radiation Therapy + Standard ADT
other name: Casodex®
intervention type: Drug
intervention name: GnRH analog
description: Anti-androgen
arm group label: Salvage Radiation Therapy + Enhanced ADT
arm group label: Salvage Radiation Therapy + Standard ADT
other name: Gonadotropin-releasing hormone analog
other name: Lupron®
other name: leuprolide acetate
other name: goserelin acetate
other name: Eligard™
other name: Viadur™
other name: Zoldaex®
other name: Trelstar®
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Edwin Posadas, MD
role: Principal Investigator
affiliation: RTOG Foundation
last name: Hiram Gay, MD
role: Principal Investigator
affiliation: RTOG Foundation
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Leuprolide
mesh term: Goserelin
mesh term: Bicalutamide
sharing ipd: No