<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/NCT03009981</url>
  </required_header>
  <id_info>
    <org_study_id>AFT-19</org_study_id>
    <nct_id>NCT03009981</nct_id>
  </id_info>
  <brief_title>A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer</brief_title>
  <official_title>A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alliance Foundation Trials, LLC.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Alliance Foundation Trials, 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>
      This is a randomized, open-label, three-arm, phase 3 study in men with biochemically&#xD;
      recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be stratified by PSA doubling time (&lt; 3 months vs. 3-9 months) and randomized&#xD;
      in 1:1:1 fashion to one of three treatment arms: (1) Control arm consisting of LHRH analogue&#xD;
      monotherapy (degarelix or leuprolide), (2) Experimental arm consisting of apalutamide in&#xD;
      combination with LHRH analogue, and (3) Experimental arm consisting of apalutamide,&#xD;
      abiraterone acetate + prednisone, and LHRH analogue. Patients will be treated for a maximum&#xD;
      duration of 52 weeks and then enter follow up phase until the time of PSA progression,&#xD;
      development of metastasis, or patient withdrawal from study, whichever occurs first. Patients&#xD;
      with PSA progression will be followed long term until the development of castration&#xD;
      resistance, first metastasis, and death.&#xD;
&#xD;
      The primary endpoint of the study is PSA progression-free survival in the intent-to-treat&#xD;
      patient population. PSA progression during the 52-week treatment period is defined as a&#xD;
      rising PSA confirmed on repeat measurement, and at least 25% and 2 ng/mL above nadir or&#xD;
      baseline, whichever is lower. PSA progression during follow up defined as PSA &gt; 0.2 ng/mL&#xD;
      confirmed by repeat measurement at least 2 weeks later. Secondary study endpoints include PSA&#xD;
      progression-free survival in testosterone-evaluable population, 36-month PSA progression-free&#xD;
      survival rate in both intent-to-treat and testosterone-evaluable populations, time to&#xD;
      testosterone recovery, time to castration resistance, metastasis-free survival, quality of&#xD;
      life, and safety. Each experimental arm will be compared against the control arm in pair-wise&#xD;
      fashion. The study is not powered to detect differences in primary or secondary endpoints&#xD;
      between the two experimental arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 1, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PSA progression-free survival in the intent-to-treat population</measure>
    <time_frame>36 months</time_frame>
    <description>To compare PSA progression-free survival in each of the experimental arms (LHRH analogue + apalutamide; LHRH analogue + apalutamide +abiraterone acetate) versus the control arm (LHRH analogue) among all randomized patients (intent-to-treat population).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PSA progression-free survival in the testosterone-evaluable population</measure>
    <time_frame>36 months</time_frame>
    <description>Compare PSA progression-free survival in testosterone-evaluable population in each experimental arm versus the control arm. Testosterone-evaluable population includes all patients who achieve serum testosterone recovery to &gt; 50 ng/dL with subsequent PSA measurements sufficient for evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSA progression-free survival in both the intent-to-treat and testosterone-evaluable populations</measure>
    <time_frame>36 months</time_frame>
    <description>To compare the 36-month PSA progression-free survival rate in each experimental arm versus the control arm in both the intent-to-treat and testosterone-evaluable populations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum testosterone</measure>
    <time_frame>12 months</time_frame>
    <description>To compare the time to recovery of serum testosterone to greater than 50 ng/dL in each experimental arm versus the control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to castration resistance</measure>
    <time_frame>6 years</time_frame>
    <description>To compare the time to castration resistance in each experimental arm versus the control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metastasis-Free Survival</measure>
    <time_frame>6 years</time_frame>
    <description>To compare metastasis-free survival in each experimental arm versus the control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>6 years</time_frame>
    <description>To compare overall survival in each experimental arm versus the control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>6 years</time_frame>
    <description>To characterize the safety profile in each treatment arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life Expanded Prostate Cancer Index Composite (EPIC)</measure>
    <time_frame>72 months</time_frame>
    <description>Expanded Prostate Cancer Index Composite (EPIC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life Hot Flash Daily Interference Scale (HFRDIS)</measure>
    <time_frame>72 months</time_frame>
    <description>Hot Flash Daily Interference Scale (HFRDIS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life EQ-5D-5L</measure>
    <time_frame>72 months</time_frame>
    <description>EQ-5D-5L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life PROMIS Fatigue</measure>
    <time_frame>72 months</time_frame>
    <description>PROMIS Fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality-adjusted survival</measure>
    <time_frame>72 months</time_frame>
    <description>To compare the quality-adjusted survival (overall survival multiplied by utility score) of patients in each experimental arm versus the control arm.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">504</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A: Degarelix Monotherapy OR Leuprolide/Bicalutamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive degarelix OR leuprolide with bicalutamide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Degarelix/Apalutamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive apalutamide and either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive apalutamide and abiraterone acetate, in addition to either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apalutamide</intervention_name>
    <description>Take apalutamide 240 mg (four 60 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.</description>
    <arm_group_label>Arm B: Degarelix/Apalutamide</arm_group_label>
    <arm_group_label>Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone</arm_group_label>
    <other_name>Erleada</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LHRH Analogue</intervention_name>
    <description>Patients will receive a LHRH analogue therapy of either Degarelix OR Leuprolide with bicalutamide.&#xD;
Degarelix:&#xD;
Patients will receive subcutaneous injections every 28 days (+/- 3 days). Patients will receive a loading dose of 240 mg (two 120 mg injections) on C1D1, followed by maintenance dose of 80 mg on Day 1 of subsequent cycles.&#xD;
Leuprolide:&#xD;
Patients treated with leuprolide will receive a 7.5 mg IM injection on C1D1. Patients in arm A ONLY will take this in combination with bicalutamide 50 mg orally once daily starting on C1D1 and continuing for 28 days through completion of cycle 1. Starting on C2D1, patients will continue on one of the following two treatments at investigator discretion:&#xD;
Leuprolide 7.5 mg IM injection on Day 1 of subsequent cycles without concurrent bicalutamide.&#xD;
OR:&#xD;
Leuprolide 22.5 mg IM injection at the following visits without concurrent bicalutamide: C2D1, C5D1, C8D1, and C11D1.</description>
    <arm_group_label>Arm A: Degarelix Monotherapy OR Leuprolide/Bicalutamide</arm_group_label>
    <arm_group_label>Arm B: Degarelix/Apalutamide</arm_group_label>
    <arm_group_label>Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone</arm_group_label>
    <other_name>Degarelix (Firmagon)</other_name>
    <other_name>Leuprolide (Lupron) and Bicalutamide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone Acetate</intervention_name>
    <description>Take abiraterone acetate 1000 mg (four 250 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.</description>
    <arm_group_label>Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone</arm_group_label>
    <other_name>Zytiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Take two prednisone 5 mg tablets daily, starting on C1D1 and continuing throughout the 52-week treatment period. Following completion of treatment period, patients will taper off prednisone per institutional guidelines. Suggested tapering plan: prednisone 5 mg daily for 7 days, then 2.5 mg daily for 7 days before discontinuing.</description>
    <arm_group_label>Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone</arm_group_label>
    <other_name>Deltasone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed prostate adenocarcinoma&#xD;
&#xD;
          -  Prior radical prostatectomy&#xD;
&#xD;
          -  Biochemically recurrent prostate cancer with PSA doubling time ≤ 9 months at the time&#xD;
             of study entry. Calculation of PSA doubling time should include the use of all&#xD;
             available PSA values obtained within past 6-12 months prior to randomization, with a&#xD;
             minimum of 3 values separated by at least 2 weeks apart. PSA values obtained prior to&#xD;
             therapeutic interventions (e.g. salvage radiation) will be excluded. PSA doubling time&#xD;
             to be estimated using Memorial Sloan Kettering Cancer Center online calculator&#xD;
             (https://www.mskcc.org/nomograms/prostate/psa-doubling-time)&#xD;
&#xD;
          -  Prior adjuvant or salvage radiation or not a candidate for radiation based upon&#xD;
             clinical assessment of disease characteristics and patient co-morbidities.&#xD;
&#xD;
          -  Screening PSA &gt; 0.5 ng/mL&#xD;
&#xD;
          -  No definitive evidence of metastases on screening CT or MRI of abdomen/pelvis and&#xD;
             radionuclide whole body bone scan per the judgment of the investigator. Abdominal&#xD;
             and/or pelvic lymph nodes measuring 2 cm or less in short axis diameter are allowed.&#xD;
             Lesions identified on other imaging modalities (e.g. PSMA or choline PET) that are not&#xD;
             visualized on CT and/or MRI or radionuclide bone scan are allowed. Equivocal lesions&#xD;
             on bone scan should be followed up with additional imaging as clinically indicated.&#xD;
&#xD;
          -  Screening serum testosterone &gt; 150 ng/dL&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Medications known to lower the seizure threshold must be discontinued or substituted&#xD;
             at least 4 weeks prior to cycle 1 day 1&#xD;
&#xD;
          -  Agrees to use a condom (even men with vasectomies) and another effective method of&#xD;
             birth control if he is having sex with a woman of childbearing potential or agrees to&#xD;
             use a condom if he is having sex with a woman who is pregnant while on study drug and&#xD;
             for 3 months following the last dose of study drug. Must also agree not to donate&#xD;
             sperm during the study and for 3 months after receiving the last dose of study drug.&#xD;
&#xD;
          -  Adequate organ function as defined by the following laboratory values at screening:&#xD;
&#xD;
               -  Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase&#xD;
                  [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase&#xD;
                  [SGPT]) &lt; 2.5 x upper limit of normal (ULN)&#xD;
&#xD;
               -  Total serum bilirubin ≤1.5 x ULN. In subjects with Gilbert's syndrome, if total&#xD;
                  bilirubin is &gt;1.5 × ULN, measure direct and indirect bilirubin and if direct&#xD;
                  bilirubin is ≤1.5 × ULN, subject may be eligible)&#xD;
&#xD;
               -  Serum potassium ≥ 3.5 mmol/L. Supplementation and re-screening is allowed.&#xD;
&#xD;
               -  Estimated creatinine clearance &gt; 45 ml/min using Cockroft-Gault equation&#xD;
&#xD;
               -  Platelets ≥ 100,000/microliter independent of transfusion and/or growth factors&#xD;
                  within 3 months prior to randomization&#xD;
&#xD;
               -  Hemoglobin ≥ 9.0 g/dL independent of transfusion and/or growth factors within 3&#xD;
                  months prior to randomization&#xD;
&#xD;
               -  Serum albumin ≥ 3.0 g/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior androgen deprivation therapy and/or first generation anti-androgen (e.g.&#xD;
             bicalutamide, nilutamide, flutamide) for biochemically recurrent prostate cancer.&#xD;
             Prior ADT and/or first generation anti-androgen in the (neo)adjuvant and/or salvage&#xD;
             setting before, during, and/or following radiation or surgery is allowed provided last&#xD;
             effective dose of ADT and/or first-generation anti-androgen is &gt; 9 months prior to&#xD;
             date of randomization and total duration of prior therapy is ≤ 36 months.&#xD;
&#xD;
          -  Prior treatment with CYP17 inhibitor (e.g. ketoconazole, abiraterone acetate,&#xD;
             galeterone) or second generation androgen receptor antagonist including apalutamide or&#xD;
             enzalutamide&#xD;
&#xD;
          -  Prior chemotherapy for prostate cancer except if administered in neoadjuvant or&#xD;
             adjuvant setting&#xD;
&#xD;
          -  Use of 5-alpha reductase inhibitor within 42 days prior to cycle 1 day 1&#xD;
&#xD;
          -  Use of investigational agent within 28 days prior to randomization&#xD;
&#xD;
          -  Use of other prohibited medications within 7 days prior to cycle 1 day 1 on study&#xD;
             (Arms B and C only)&#xD;
&#xD;
          -  Prior bilateral orchiectomy&#xD;
&#xD;
          -  Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within&#xD;
             1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or&#xD;
             other benign CNS or meningeal disease which may require treatment with surgery or&#xD;
             radiation therapy)&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Gastrointestinal disorder affecting absorption or the ability to swallow tablets&#xD;
&#xD;
          -  Baseline severe hepatic impairment (Child-Pugh Class B &amp; C)&#xD;
&#xD;
          -  Intercurrent illness that is not controlled such as active infection, psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements&#xD;
&#xD;
          -  Any chronic medical condition requiring a higher dose of corticosteroid than&#xD;
             equivalent of 5 mg prednisone/prednisolone once daily&#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>Suzanne George, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alliance Foundation Trials, LLC.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rahul Aggarwal, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Mayo Clinic - Phoenix</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hospital</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palo Alto Medical Foundation</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Central California Health Care System</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hospital</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palo Alto Medical Foundation</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palo Alto Medical Foundation</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adventist Health St. Helena/St. Helena Hospital/Martin O'Neil Cancer Center</name>
      <address>
        <city>Saint Helena</city>
        <state>California</state>
        <zip>94574</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego - Moores Cancer Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</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>Palo Alto Medical Foundation</name>
      <address>
        <city>Santa Cruz</city>
        <state>California</state>
        <zip>95065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palo Alto Medical Foundation</name>
      <address>
        <city>Sunnyvale</city>
        <state>California</state>
        <zip>94086</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pali Momi Medical Center</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Hawaii Cancer Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>606012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Comprehensive Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northshore University Health System</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quincy Medical Group</name>
      <address>
        <city>Quincy</city>
        <state>Illinois</state>
        <zip>62301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Maine Medical Center</name>
      <address>
        <city>Brewer</city>
        <state>Maine</state>
        <zip>04412</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Cancer Specialists</name>
      <address>
        <city>Kennebunk</city>
        <state>Maine</state>
        <zip>04043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Cancer Specialists</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Cancer Specialists</name>
      <address>
        <city>Topsham</city>
        <state>Maine</state>
        <zip>04086</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Milford</city>
        <state>Massachusetts</state>
        <zip>01757</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>South Weymouth</city>
        <state>Massachusetts</state>
        <zip>02190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro Minnesota Community Oncology Research Consortium</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</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>Nebraska Methodist Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nevada Cancer Research Foundation</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hampshire Oncology &amp; Hematology</name>
      <address>
        <city>Concord</city>
        <state>New Hampshire</state>
        <zip>03301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hampshire Oncology &amp; Hematology</name>
      <address>
        <city>Hooksett</city>
        <state>New Hampshire</state>
        <zip>03106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Health System/Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07962</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Mexico Oncology Hematology Consultants</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Comprehensive Cancer Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Medical Center- Cancer Center</name>
      <address>
        <city>Las Cruces</city>
        <state>New Mexico</state>
        <zip>88011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christus St. Vincent's Regional Cancer Center</name>
      <address>
        <city>Santa Fe</city>
        <state>New Mexico</state>
        <zip>87505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Western New York</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>11533</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical Ctr - New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10461</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>University of North Carolina Hospital</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novant Health Presbyterian Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Salisbury</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Physicians Miami Valley South</name>
      <address>
        <city>Centerville</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Toledo Clinic</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Cancer Specialists and Research Institute</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spartanburg Medical Center/Gibbs Cancer Center</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic Cancer Center</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert Hospital/Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.</citation>
    <PMID>25559415</PMID>
  </reference>
  <reference>
    <citation>Zietman AL, Chung CS, Coen JJ, Shipley WU. 10-year outcome for men with localized prostate cancer treated with external radiation therapy: results of a cohort study. J Urol. 2004 Jan;171(1):210-4. doi: 10.1097/01.ju.0000100980.13364.a6.</citation>
    <PMID>14665878</PMID>
  </reference>
  <reference>
    <citation>Humphrey PA, Moch H, Cubilla AL, Ulbright TM, Reuter VE. The 2016 WHO Classification of Tumours of the Urinary System and Male Genital Organs-Part B: Prostate and Bladder Tumours. Eur Urol. 2016 Jul;70(1):106-119. doi: 10.1016/j.eururo.2016.02.028. Epub 2016 Mar 17.</citation>
    <PMID>26996659</PMID>
  </reference>
  <reference>
    <citation>Zelefsky MJ, Ben-Porat L, Scher HI, Chan HM, Fearn PA, Fuks ZY, Leibel SA, Venkatraman ES. Outcome predictors for the increasing PSA state after definitive external-beam radiotherapy for prostate cancer. J Clin Oncol. 2005 Feb 1;23(4):826-31. doi: 10.1200/JCO.2005.02.111.</citation>
    <PMID>15681527</PMID>
  </reference>
  <reference>
    <citation>Qu Y, Dai B, Ye D, Kong Y, Chang K, Jia Z, Yang X, Zhang H, Zhu Y, Shi G. Constitutively active AR-V7 plays an essential role in the development and progression of castration-resistant prostate cancer. Sci Rep. 2015 Jan 7;5:7654. doi: 10.1038/srep07654.</citation>
    <PMID>25563505</PMID>
  </reference>
  <reference>
    <citation>Gershon RC, Rothrock N, Hanrahan R, Bass M, Cella D. The use of PROMIS and assessment center to deliver patient-reported outcome measures in clinical research. J Appl Meas. 2010;11(3):304-14.</citation>
    <PMID>20847477</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>July 1, 2023</last_update_submitted>
  <last_update_submitted_qc>July 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PSA</keyword>
  <keyword>Degarelix</keyword>
  <keyword>Apalutamide</keyword>
  <keyword>Abiraterone Acetate</keyword>
  <keyword>Radical Prostatectomy</keyword>
  <keyword>Bicalutamide</keyword>
  <keyword>Leuprolide</keyword>
  <keyword>Lupron</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>Prednisone</mesh_term>
    <mesh_term>Leuprolide</mesh_term>
    <mesh_term>Abiraterone Acetate</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/NCT03009981
org study id: AFT-19
nct id: NCT03009981
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, open-label, three-arm, phase 3 study in men with biochemically
      recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
Patients will be stratified by PSA doubling time (< 3 months vs. 3-9 months) and randomized
      in 1:1:1 fashion to one of three treatment arms: (1) Control arm consisting of LHRH analogue
      monotherapy (degarelix or leuprolide), (2) Experimental arm consisting of apalutamide in
      combination with LHRH analogue, and (3) Experimental arm consisting of apalutamide,
      abiraterone acetate + prednisone, and LHRH analogue. Patients will be treated for a maximum
      duration of 52 weeks and then enter follow up phase until the time of PSA progression,
      development of metastasis, or patient withdrawal from study, whichever occurs first. Patients
      with PSA progression will be followed long term until the development of castration
      resistance, first metastasis, and death.

      The primary endpoint of the study is PSA progression-free survival in the intent-to-treat
      patient population. PSA progression during the 52-week treatment period is defined as a
      rising PSA confirmed on repeat measurement, and at least 25% and 2 ng/mL above nadir or
      baseline, whichever is lower. PSA progression during follow up defined as PSA > 0.2 ng/mL
      confirmed by repeat measurement at least 2 weeks later. Secondary study endpoints include PSA
      progression-free survival in testosterone-evaluable population, 36-month PSA progression-free
      survival rate in both intent-to-treat and testosterone-evaluable populations, time to
      testosterone recovery, time to castration resistance, metastasis-free survival, quality of
      life, and safety. Each experimental arm will be compared against the control arm in pair-wise
      fashion. The study is not powered to detect differences in primary or secondary endpoints
      between the two experimental arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PSA progression-free survival in the intent-to-treat population
time frame: 36 months
description: To compare PSA progression-free survival in each of the experimental arms (LHRH analogue + apalutamide; LHRH analogue + apalutamide +abiraterone acetate) versus the control arm (LHRH analogue) among all randomized patients (intent-to-treat population).
measure: PSA progression-free survival in the testosterone-evaluable population
time frame: 36 months
description: Compare PSA progression-free survival in testosterone-evaluable population in each experimental arm versus the control arm. Testosterone-evaluable population includes all patients who achieve serum testosterone recovery to > 50 ng/dL with subsequent PSA measurements sufficient for evaluation
measure: PSA progression-free survival in both the intent-to-treat and testosterone-evaluable populations
time frame: 36 months
description: To compare the 36-month PSA progression-free survival rate in each experimental arm versus the control arm in both the intent-to-treat and testosterone-evaluable populations.
measure: Serum testosterone
time frame: 12 months
description: To compare the time to recovery of serum testosterone to greater than 50 ng/dL in each experimental arm versus the control arm.
measure: Time to castration resistance
time frame: 6 years
description: To compare the time to castration resistance in each experimental arm versus the control arm.
measure: Metastasis-Free Survival
time frame: 6 years
description: To compare metastasis-free survival in each experimental arm versus the control arm.
measure: Overall Survival
time frame: 6 years
description: To compare overall survival in each experimental arm versus the control arm.
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: 6 years
description: To characterize the safety profile in each treatment arm
measure: Quality of life Expanded Prostate Cancer Index Composite (EPIC)
time frame: 72 months
description: Expanded Prostate Cancer Index Composite (EPIC)
measure: Quality of life Hot Flash Daily Interference Scale (HFRDIS)
time frame: 72 months
description: Hot Flash Daily Interference Scale (HFRDIS)
measure: Quality of life EQ-5D-5L
time frame: 72 months
description: EQ-5D-5L
measure: Quality of life PROMIS Fatigue
time frame: 72 months
description: PROMIS Fatigue
measure: Quality-adjusted survival
time frame: 72 months
description: To compare the quality-adjusted survival (overall survival multiplied by utility score) of patients in each experimental arm versus the control arm.
arm group label: Arm A: Degarelix Monotherapy OR Leuprolide/Bicalutamide
arm group type: Active Comparator
description: Patients will receive degarelix OR leuprolide with bicalutamide.
arm group label: Arm B: Degarelix/Apalutamide
arm group type: Experimental
description: Patients will receive apalutamide and either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.
arm group label: Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone
arm group type: Experimental
description: Patients will receive apalutamide and abiraterone acetate, in addition to either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.
intervention type: Drug
intervention name: Apalutamide
description: Take apalutamide 240 mg (four 60 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.
arm group label: Arm B: Degarelix/Apalutamide
arm group label: Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone
other name: Erleada
intervention type: Drug
intervention name: LHRH Analogue
description: Patients will receive a LHRH analogue therapy of either Degarelix OR Leuprolide with bicalutamide.
Degarelix:
Patients will receive subcutaneous injections every 28 days (+/- 3 days). Patients will receive a loading dose of 240 mg (two 120 mg injections) on C1D1, followed by maintenance dose of 80 mg on Day 1 of subsequent cycles.
Leuprolide:
Patients treated with leuprolide will receive a 7.5 mg IM injection on C1D1. Patients in arm A ONLY will take this in combination with bicalutamide 50 mg orally once daily starting on C1D1 and continuing for 28 days through completion of cycle 1. Starting on C2D1, patients will continue on one of the following two treatments at investigator discretion:
Leuprolide 7.5 mg IM injection on Day 1 of subsequent cycles without concurrent bicalutamide.
OR:
Leuprolide 22.5 mg IM injection at the following visits without concurrent bicalutamide: C2D1, C5D1, C8D1, and C11D1.
arm group label: Arm A: Degarelix Monotherapy OR Leuprolide/Bicalutamide
arm group label: Arm B: Degarelix/Apalutamide
arm group label: Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone
other name: Degarelix (Firmagon)
other name: Leuprolide (Lupron) and Bicalutamide
intervention type: Drug
intervention name: Abiraterone Acetate
description: Take abiraterone acetate 1000 mg (four 250 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.
arm group label: Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone
other name: Zytiga
intervention type: Drug
intervention name: Prednisone
description: Take two prednisone 5 mg tablets daily, starting on C1D1 and continuing throughout the 52-week treatment period. Following completion of treatment period, patients will taper off prednisone per institutional guidelines. Suggested tapering plan: prednisone 5 mg daily for 7 days, then 2.5 mg daily for 7 days before discontinuing.
arm group label: Arm C: Degarelix/Apalutamide/Abiraterone/Prednisone
other name: Deltasone
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suzanne George, MD
role: Principal Investigator
affiliation: Alliance Foundation Trials, LLC.
last name: Rahul Aggarwal, MD
role: Study Chair
affiliation: University of California, San Francisco
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country: United States
citation: Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.
PMID: 25559415
citation: Zietman AL, Chung CS, Coen JJ, Shipley WU. 10-year outcome for men with localized prostate cancer treated with external radiation therapy: results of a cohort study. J Urol. 2004 Jan;171(1):210-4. doi: 10.1097/01.ju.0000100980.13364.a6.
PMID: 14665878
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responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prednisone
mesh term: Leuprolide
mesh term: Abiraterone Acetate
mesh term: Bicalutamide
sharing ipd: No