<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/NCT03043807</url>
  </required_header>
  <id_info>
    <org_study_id>J16151</org_study_id>
    <secondary_id>IRB00120414</secondary_id>
    <nct_id>NCT03043807</nct_id>
  </id_info>
  <brief_title>A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy</brief_title>
  <official_title>A Phase II Study of Definitive Therapy for Newly Diagnosed Men With Oligometastatic Prostate Cancer After Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</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>
      To assess the safety of treating men with oligometastatic prostate cancer with the following&#xD;
      therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant&#xD;
      androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control&#xD;
      with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to&#xD;
      oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation.&#xD;
      Androgen blockade will be the same throughout the course of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adjuvant treatment (month 1 through ~6): All patients will be treated with up to 6 months of&#xD;
      androgen deprivation, plus up to 6 cycles of docetaxel chemotherapy. Following docetaxel&#xD;
      therapy, patients with a Prostate-specific antigen response of at least a 50% decrease from&#xD;
      baseline, will proceed to maximum consolidative therapy.&#xD;
&#xD;
      Radiation (month 7 though ~11): After completion of adjuvant chemotherapy, the men will be&#xD;
      treated with definitive local therapy with adjuvant radiation therapy (RT). After definitive&#xD;
      local therapy, patients will be treated with consolidative stereotactic body radiation&#xD;
      therapy (SBRT) to the metastatic sites (if present).&#xD;
&#xD;
      Follow up: Patients will continue on androgen deprivation for a total of 2 years. They will&#xD;
      be followed clinically and monitored with serum testosterone and Prostate-specific antigen&#xD;
      until 2-years after completion of ADT (Androgen deprivation therapy) treatment. Androgen&#xD;
      blockade will be the same throughout the course of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Actual">October 17, 2022</completion_date>
  <primary_completion_date type="Actual">October 17, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate</measure>
    <time_frame>3 years</time_frame>
    <description>To evaluate efficacy of multimodality therapy in men, defined as the 3 year Prostate-specific antigen progression-free (Prostate-specific antigen&lt;0.2 ng/ml) survival rate among men who have non-castrate testosterone levels 2 years after enrollment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of the 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification</measure>
    <time_frame>3 years</time_frame>
    <description>To assess the safety of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer after prostatectomy. Toxicities related to neoadjuvant therapy, radiation therapy, or stereotactic body radiation therapy (SBRT) will be assessed using CTCAE version 4 criteria. Surgical toxicities will be assessed using the Clavien-Dindo Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Prostate-specific Antigen Recurrence</measure>
    <time_frame>3 years</time_frame>
    <description>To investigate the time from an undetectable Prostate-specific antigen (≤0.2 ng/mL) until the Prostate-specific antigen is &gt;0.2 over two time-points.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>chemohormonal and definitive therapy after prostatectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leuprolide Acetate</intervention_name>
    <description>22.5mg by intramuscular (IM) injection every 3 months</description>
    <arm_group_label>chemohormonal and definitive therapy after prostatectomy</arm_group_label>
    <other_name>Lupron Deport</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.</description>
    <arm_group_label>chemohormonal and definitive therapy after prostatectomy</arm_group_label>
    <other_name>Texotere</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bicalutamide</intervention_name>
    <description>bicalutamide (Casodex) 50mg by mouth daily</description>
    <arm_group_label>chemohormonal and definitive therapy after prostatectomy</arm_group_label>
    <other_name>Casodex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation</intervention_name>
    <description>Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.</description>
    <arm_group_label>chemohormonal and definitive therapy after prostatectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone Acetate</intervention_name>
    <description>Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.</description>
    <arm_group_label>chemohormonal and definitive therapy after prostatectomy</arm_group_label>
    <other_name>Zytiga</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Willing and able to provide written informed consent.&#xD;
&#xD;
          2. Age ≥ 18 years&#xD;
&#xD;
          3. Eastern cooperative oncology group (ECOG) performance status ≤2&#xD;
&#xD;
          4. Documented histologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          5. Willing to undergo the following therapy: (1st) Systemic chemo-hormonal therapy with&#xD;
             up to 6-months (~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of&#xD;
             chemotherapy, (2nd) definitive local tumor control with adjuvant radiation therapy,&#xD;
             and (3rd) consolidative stereotactic radiation to oligometastatic lesions.&#xD;
             Additionally, must be willing to be treated with a full two years of androgen&#xD;
             deprivation.&#xD;
&#xD;
          6. Oligometastatic prostate cancer: Stage T1-4, N0-1 and/or M1a-b (up to 5 metastatic&#xD;
             lesions- including bone lesions and non-regional lymph nodes seen on bone scan,&#xD;
             contrast enhanced CT scan, or positron emission tomography PET scan)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior local non-surgical therapy to treat prostate cancer (e.g. radiation therapy,&#xD;
             brachytherapy)&#xD;
&#xD;
          2. Prior therapy to a metastatic site.&#xD;
&#xD;
          3. Prior or ongoing systemic therapy for prostate cancer including, but not limited to:&#xD;
&#xD;
               1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)&#xD;
&#xD;
               2. CYP-17 (cytochrome P450 17α-hydroxy/17,20-lyase) inhibitors (e.g. ketoconazole)&#xD;
&#xD;
               3. Antiandrogens (e.g. bicalutamide, nilutamide)&#xD;
&#xD;
               4. Second generation antiandrogens (e.g. enzalutamide, abiraterone)&#xD;
&#xD;
               5. Immunotherapy (e.g. sipuleucel-T, ipilimumab)&#xD;
&#xD;
               6. Chemotherapy (e.g. docetaxel, cabazitaxel) *Note: may be enrolled if hormone&#xD;
                  therapy was recently initiated (&lt;90 days duration)). In the event that hormone&#xD;
                  therapy was initiated prior to study enrollment, the clock for 2 years of&#xD;
                  androgen deprivation would begin at the time of therapy initiation, rather than&#xD;
                  at study enrollment.&#xD;
&#xD;
          4. Evidence of serious and/or unstable pre-existing medical, psychiatric or other&#xD;
             condition (including laboratory abnormalities) that could interfere with patient&#xD;
             safety or provision of informed consent to participate in this study.&#xD;
&#xD;
          5. Any psychological, familial, sociological, or geographical condition that could&#xD;
             potentially interfere with compliance with the study protocol and follow-up schedule.&#xD;
&#xD;
          6. Abnormal bone marrow function [absolute neutrophil count (ANC)&lt;1500/mm3, platelet&#xD;
             count &lt;100,000/mm3, hemoglobin &lt;9 g/dL]&#xD;
&#xD;
          7. Abnormal liver function (bilirubin &gt;ULN ( upper limit of normal); AST (aspartate&#xD;
             aminotransferase), ALT (alanine transaminase) &gt; 2.5 x upper limit of normal)&#xD;
&#xD;
          8. Creatinine clearance of ≥ 30 mL/min. CrCl (Creatinine clearance) should be calculated&#xD;
             suing the Cockcroft-Gault formula.&#xD;
&#xD;
          9. Active cardiac disease defined as active angina, symptomatic congestive heart failure,&#xD;
             or myocardial infarction within previous six months.&#xD;
&#xD;
         10. Prior history of malignancy in the past 3 years with the exception of basal cell and&#xD;
             squamous cell carcinoma of the skin. Other malignancies that are considered to have a&#xD;
             low potential to progress may be enrolled at discretion of PI.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth Pienta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SKCCC at Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Sibley Memorial Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <results_first_submitted>December 20, 2022</results_first_submitted>
  <results_first_submitted_qc>January 20, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 16, 2023</results_first_posted>
  <last_update_submitted>January 20, 2023</last_update_submitted>
  <last_update_submitted_qc>January 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostatectomy</keyword>
  <keyword>androgen deprivation</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>radiation</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>Docetaxel</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03043807/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Chemohormonal and Definitive Therapy After Prostatectomy</title>
          <description>(1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.&#xD;
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months&#xD;
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.&#xD;
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily&#xD;
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.&#xD;
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Chemohormonal and Definitive Therapy After Prostatectomy</title>
          <description>(1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.&#xD;
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months&#xD;
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.&#xD;
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily&#xD;
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.&#xD;
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.2" lower_limit="55.3" upper_limit="66.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate</title>
        <description>To evaluate efficacy of multimodality therapy in men, defined as the 3 year Prostate-specific antigen progression-free (Prostate-specific antigen&lt;0.2 ng/ml) survival rate among men who have non-castrate testosterone levels 2 years after enrollment.</description>
        <time_frame>3 years</time_frame>
        <population>Assessed 25/26 patients (1 patient withdrew from study prior completing TED)</population>
        <group_list>
          <group group_id="O1">
            <title>Chemohormonal and Definitive Therapy After Prostatectomy</title>
            <description>(1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.&#xD;
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months&#xD;
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.&#xD;
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily&#xD;
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.&#xD;
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate</title>
          <description>To evaluate efficacy of multimodality therapy in men, defined as the 3 year Prostate-specific antigen progression-free (Prostate-specific antigen&lt;0.2 ng/ml) survival rate among men who have non-castrate testosterone levels 2 years after enrollment.</description>
          <population>Assessed 25/26 patients (1 patient withdrew from study prior completing TED)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>3-year Prostate-specific antigen PFS (Prostate-specific antigen &lt;0.2), after enrollment</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3-year Prostate-specific antigen PFS (Prostate-specific antigen &gt;=0.2), after enrollment</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of the 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification</title>
        <description>To assess the safety of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer after prostatectomy. Toxicities related to neoadjuvant therapy, radiation therapy, or stereotactic body radiation therapy (SBRT) will be assessed using CTCAE version 4 criteria. Surgical toxicities will be assessed using the Clavien-Dindo Classification</description>
        <time_frame>3 years</time_frame>
        <population>Assessed all patients, from time of enrollment until study exit/3 years from enrollment.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemohormonal and Definitive Therapy After Prostatectomy</title>
            <description>(1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.&#xD;
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months&#xD;
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.&#xD;
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily&#xD;
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.&#xD;
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of the 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification</title>
          <description>To assess the safety of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer after prostatectomy. Toxicities related to neoadjuvant therapy, radiation therapy, or stereotactic body radiation therapy (SBRT) will be assessed using CTCAE version 4 criteria. Surgical toxicities will be assessed using the Clavien-Dindo Classification</description>
          <population>Assessed all patients, from time of enrollment until study exit/3 years from enrollment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>grade 4 neutropenia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>grade 3 neutropenic fever</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Grades 3 and 4 neutropenia and surgical- or radiation-induced toxicities.</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Prostate-specific Antigen Recurrence</title>
        <description>To investigate the time from an undetectable Prostate-specific antigen (≤0.2 ng/mL) until the Prostate-specific antigen is &gt;0.2 over two time-points.</description>
        <time_frame>3 years</time_frame>
        <population>Assessed 25/26 patients (1 patient withdrew from study prior completing TED)</population>
        <group_list>
          <group group_id="O1">
            <title>Chemohormonal and Definitive Therapy After Prostatectomy</title>
            <description>(1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.&#xD;
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months&#xD;
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.&#xD;
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily&#xD;
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.&#xD;
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Prostate-specific Antigen Recurrence</title>
          <description>To investigate the time from an undetectable Prostate-specific antigen (≤0.2 ng/mL) until the Prostate-specific antigen is &gt;0.2 over two time-points.</description>
          <population>Assessed 25/26 patients (1 patient withdrew from study prior completing TED)</population>
          <units>Month</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">The median time to PSA (Prostate-specific antigen) recurrence within 3 years was not reached because at that timepoint, less than 50% of the participants had experienced a PSA recurrence.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Chemohormonal and Definitive Therapy After Prostatectomy</title>
          <description>(1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.&#xD;
Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months&#xD;
Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.&#xD;
Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily&#xD;
Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.&#xD;
Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>neutropenic fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>gastritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>gastrointestinal reflux</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>mucositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>oral candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>heartburn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>hematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>xerostomia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>fatigue</sub_title>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>weight gain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>elevated ALT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>elevated AST</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>anorexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>pain (bilateral legs)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>pain (joint);</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>pain (pelvis)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>general body aches</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>neuropathy</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>dysgeusia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>memory impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>depression</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>hematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>hiccups</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>dyspnea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>alopecia;</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>skin alterations</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>xerosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>edema (lower extremity)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>nail ridging</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>pruritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>infusion related reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>nail discoloration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>hot flashes</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kenneth Pienta</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>4105023137</phone>
      <email>kpienta1@jh.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03043807
org study id: J16151
secondary id: IRB00120414
nct id: NCT03043807
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To assess the safety of treating men with oligometastatic prostate cancer with the following
      therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant
      androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control
      with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to
      oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation.
      Androgen blockade will be the same throughout the course of treatment.
Adjuvant treatment (month 1 through ~6): All patients will be treated with up to 6 months of
      androgen deprivation, plus up to 6 cycles of docetaxel chemotherapy. Following docetaxel
      therapy, patients with a Prostate-specific antigen response of at least a 50% decrease from
      baseline, will proceed to maximum consolidative therapy.

      Radiation (month 7 though ~11): After completion of adjuvant chemotherapy, the men will be
      treated with definitive local therapy with adjuvant radiation therapy (RT). After definitive
      local therapy, patients will be treated with consolidative stereotactic body radiation
      therapy (SBRT) to the metastatic sites (if present).

      Follow up: Patients will continue on androgen deprivation for a total of 2 years. They will
      be followed clinically and monitored with serum testosterone and Prostate-specific antigen
      until 2-years after completion of ADT (Androgen deprivation therapy) treatment. Androgen
      blockade will be the same throughout the course of treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate
time frame: 3 years
description: To evaluate efficacy of multimodality therapy in men, defined as the 3 year Prostate-specific antigen progression-free (Prostate-specific antigen<0.2 ng/ml) survival rate among men who have non-castrate testosterone levels 2 years after enrollment.
measure: Safety of the 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification
time frame: 3 years
description: To assess the safety of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer after prostatectomy. Toxicities related to neoadjuvant therapy, radiation therapy, or stereotactic body radiation therapy (SBRT) will be assessed using CTCAE version 4 criteria. Surgical toxicities will be assessed using the Clavien-Dindo Classification
measure: Time to Prostate-specific Antigen Recurrence
time frame: 3 years
description: To investigate the time from an undetectable Prostate-specific antigen (≤0.2 ng/mL) until the Prostate-specific antigen is >0.2 over two time-points.
arm group label: chemohormonal and definitive therapy after prostatectomy
arm group type: Experimental
description: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
intervention type: Drug
intervention name: Leuprolide Acetate
description: 22.5mg by intramuscular (IM) injection every 3 months
arm group label: chemohormonal and definitive therapy after prostatectomy
other name: Lupron Deport
intervention type: Drug
intervention name: Docetaxel
description: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.
arm group label: chemohormonal and definitive therapy after prostatectomy
other name: Texotere
intervention type: Drug
intervention name: Bicalutamide
description: bicalutamide (Casodex) 50mg by mouth daily
arm group label: chemohormonal and definitive therapy after prostatectomy
other name: Casodex
intervention type: Radiation
intervention name: Radiation
description: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.
arm group label: chemohormonal and definitive therapy after prostatectomy
intervention type: Drug
intervention name: Abiraterone Acetate
description: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
arm group label: chemohormonal and definitive therapy after prostatectomy
other name: Zytiga
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kenneth Pienta, MD
role: Principal Investigator
affiliation: SKCCC at Johns Hopkins University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Docetaxel
mesh term: Leuprolide
mesh term: Abiraterone Acetate
mesh term: Bicalutamide
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 