<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/NCT02228265</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00009259</org_study_id>
    <secondary_id>NCI-2014-01438</secondary_id>
    <secondary_id>MR00046920</secondary_id>
    <secondary_id>IRB00009259</secondary_id>
    <nct_id>NCT02228265</nct_id>
  </id_info>
  <brief_title>Molecular Features and Pathways in Predicting Drug Resistance in Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Enzalutamide</brief_title>
  <official_title>Identifying Mechanisms of Resistance to Enzalutamide (MDV3100) Treatment in Men With Castration-Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OHSU Knight Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>OHSU Knight Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research trial studies molecular features and pathways in predicting drug resistance in&#xD;
      patients with castration-resistant prostate cancer that has spread to other parts of the body&#xD;
      and who are receiving enzalutamide. Studying samples of blood and tissue in the laboratory&#xD;
      from patients receiving enzalutamide may help doctors learn more about molecular features and&#xD;
      pathways that may cause prostate cancer to be resistant to the drug.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the correlations between baseline molecular features and pathways and&#xD;
      prostate-specific antigen (PSA) response (&lt;/&gt;= 50% decline) at 12 weeks versus (vs.)&#xD;
      baseline.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the correlations between the baseline molecular features and pathways and&#xD;
      progression-free survival (defined as time from day 1 of study drug treatment to date of&#xD;
      radiographic progression or clinical progression), disease-specific survival (defined as the&#xD;
      time from day 1 of study drug to date of death from prostate cancer), and overall survival&#xD;
      (defined as time from day 1 of study drug treatment to date of death from any cause).&#xD;
&#xD;
      II. To assess the correlations between the baseline molecular features and pathways and time&#xD;
      to PSA progression.&#xD;
&#xD;
      III. To identify molecular features and cellular pathways present in tumors from men with&#xD;
      metastatic castrate-resistant prostate cancer (CRPC) that are progressing despite&#xD;
      enzalutamide treatment.&#xD;
&#xD;
      IV. To explore correlation between baseline molecular features and pathways and objective&#xD;
      response.&#xD;
&#xD;
      V. To assess the correlations between the baseline molecular features and pathways and degree&#xD;
      of PSA decline at 12 weeks and maximal PSA decline observed while on study.&#xD;
&#xD;
      VI. To assess the correlations between the baseline molecular features and time on treatment.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To assess correlations between cell-free deoxyribonucleic acid (cfDNA) molecular features&#xD;
      from blood and molecular features and pathways from the biopsy samples.&#xD;
&#xD;
      II. To assess correlations between cfDNA molecular features and endpoints in the primary and&#xD;
      secondary objectives listed above.&#xD;
&#xD;
      III. To explore correlations with baseline molecular features and tissue histology.&#xD;
&#xD;
      IV. To explore correlations with baseline tissue histology and PSA change, time to PSA&#xD;
      progression, time on treatment, progression-free survival, and overall survival.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo collection of blood and tissue samples at baseline, during administration of&#xD;
      enzalutamide, and after the time of disease progression for analysis via&#xD;
      immunohistochemistry, comparative genome hybridization, and sequencing.&#xD;
&#xD;
      After completion of study, patients are followed up every 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2013</start_date>
  <completion_date type="Actual">February 27, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PSA response, a binary variable indicating whether the PSA level has declined &gt;= 50% within 12 weeks of beginning enzalutamide treatment</measure>
    <time_frame>Within 12 weeks</time_frame>
    <description>Will be reported with 95% exact confidence interval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Degree of PSA decline</measure>
    <time_frame>12 weeks</time_frame>
    <description>Simple linear regression will be used to assess the association between molecular biomarker predictors and the continuous endpoints. Logarithm transformation or other forms of transformation may be conducted to the continuous endpoints to address the skewedness of the distributions if necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-specific survival</measure>
    <time_frame>Time from day 1 of the study drug to date of death from prostate cancer, assessed up to 4 years</time_frame>
    <description>Will be graphically illustrated using Kaplan-Meier plots of estimated survival distribution for patients (&lt;/&gt;= 50%) PSA decline at 12 weeks. Log-rank test will be fitted to determine whether the estimated survival distribution of each time-to-event endpoint differs for patients with PSA decline &gt;= 50% versus patients with PSA decline &lt; 50%. Cox regression models will be fitted to obtain the estimated hazard ratio for each time-to-event endpoints for patients who had &gt;= 50% PSA decline at 12 weeks versus those who had not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal PSA decline observed while on study</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Simple linear regression will be used to assess the association between molecular biomarker predictors and the continuous endpoints. Logarithm transformation or other forms of transformation may be conducted to the continuous endpoints to address the skewedness of the distributions if necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Molecular features</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Will assess correlations between the baseline molecular features and time on treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Will be summarized using the estimated proportion and 95% confidence interval. Simple logistic regression model will be used to assess the association between molecular biomarker predictors and these binary secondary endpoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Time from day 1 of study drug treatment to date of death from any cause, assessed up to 4 years</time_frame>
    <description>Will be graphically illustrated using Kaplan-Meier plots of estimated survival distribution for patients (&lt;/&gt;= 50%) PSA decline at 12 weeks. Log-rank test will be fitted to determine whether the estimated survival distribution of each time-to-event endpoint differs for patients with PSA decline &gt;= 50% versus patients with PSA decline &lt; 50%. Cox regression models will be fitted to obtain the estimated hazard ratio for each time-to-event endpoints for patients who had &gt;= 50% PSA decline at 12 weeks versus those who had not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression for a subgroup of patients who have metastatic castration resistant prostate cancer and have received enzalutamide treatment</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Will be summarized using the estimated proportion and 95% confidence interval. Simple logistic regression model will be used to assess the association between molecular biomarker predictors and these binary secondary endpoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>Time from day 1 of study drug treatment to date of first documented radiographic progression or clinical progression, assessed up to 4 years</time_frame>
    <description>Will be graphically illustrated using Kaplan-Meier plots of estimated survival distribution for patients (&lt;/&gt;= 50%) PSA decline at 12 weeks. Log-rank test will be fitted to determine whether the estimated survival distribution of each time-to-event endpoint differs for patients with PSA decline &gt;= 50% versus patients with PSA decline &lt; 50%. Cox regression models will be fitted to obtain the estimated hazard ratio for each time-to-event endpoints for patients who had &gt;= 50% PSA decline at 12 weeks versus those who had not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to PSA progression</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Will be graphically illustrated using Kaplan-Meier plots of estimated survival distribution for patients (&lt;/&gt;= 50%) PSA decline at 12 weeks. Log-rank test will be fitted to determine whether the estimated survival distribution of each time-to-event endpoint differs for patients with PSA decline &gt;= 50% versus patients with PSA decline &lt; 50%. Cox regression models will be fitted to obtain the estimated hazard ratio for each time-to-event endpoints for patients who had &gt;= 50% PSA decline at 12 weeks versus those who had not.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">41</enrollment>
  <condition>Castration Levels of Testosterone</condition>
  <condition>Castration-Resistant Prostate Carcinoma</condition>
  <condition>Prostate Adenocarcinoma</condition>
  <condition>PSA Progression</condition>
  <condition>Recurrent Prostate Carcinoma</condition>
  <condition>Stage IV Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Ancillary-Correlative (genetic analysis)</arm_group_label>
    <description>Patients undergo collection of blood and tissue samples at baseline, during administration of enzalutamide and after the time of disease progression for analysis via immunohistochemistry, comparative genome hybridization, and sequencing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cytology Specimen Collection Procedure</intervention_name>
    <description>Undergo blood and tissue collection</description>
    <arm_group_label>Ancillary-Correlative (genetic analysis)</arm_group_label>
    <other_name>Cytologic Sampling</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Ancillary-Correlative (genetic analysis)</arm_group_label>
    <other_name>ASP9785</other_name>
    <other_name>MDV3100</other_name>
    <other_name>Xtandi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Ancillary-Correlative (genetic analysis)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tissue and blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with prostate cancer treated at Oregon Health and Science University Knight Cancer&#xD;
        Institute&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed adenocarcinoma of the prostate without&#xD;
             neuroendocrine differentiation or small cell features&#xD;
&#xD;
          -  Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH)&#xD;
             analogue or orchiectomy (i.e., surgical or medical castration); for patients who have&#xD;
             not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue&#xD;
             therapy for the duration of the trial&#xD;
&#xD;
          -  Radiographic evidence of regional or distant metastases with suspected tumor in an&#xD;
             area that is safe to biopsy&#xD;
&#xD;
          -  Willingness to undergo a tumor biopsy at baseline and at disease progression&#xD;
&#xD;
          -  Serum testosterone level &lt; 50 ng/dL at screening&#xD;
&#xD;
          -  Progressive disease by PSA or imaging in the setting of medical or surgical&#xD;
             castration; disease progression for study entry is defined as one or more of the&#xD;
             following three criteria:&#xD;
&#xD;
               -  PSA progression defined by a minimum of three rising PSA levels with an interval&#xD;
                  of &gt;= 1 week between each determination; the PSA value at screening should be &gt;=&#xD;
                  2 ug/L (2 ng/ml)&#xD;
&#xD;
               -  Soft tissue disease progression defined by Response Evaluation Criteria in Solid&#xD;
                  Tumors (RECIST 1.1)&#xD;
&#xD;
               -  Bone disease progression defined by two or more new lesions on bone scan&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2&#xD;
&#xD;
          -  Clinically able, in the opinion of the investigator, to receive MDV3100 (enzalutamide)&#xD;
&#xD;
          -  Willing and able to give informed consent&#xD;
&#xD;
          -  A minimum of 4 weeks elapsed off of anti-androgen therapy prior to enrollment for&#xD;
             flutamide and 6 weeks for bicalutamide and nilutamide without evidence of an&#xD;
             anti-androgen withdrawal response; patients who NEVER HAD A PSA decline with the most&#xD;
             recent anti-androgen therapy or in whom the response to the most recent anti-androgen&#xD;
             was for &lt; 3 months require only a 2 week washout period prior to first dose of study&#xD;
             drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe, concurrent disease, infection, or co-morbidity that, in the judgment of the&#xD;
             investigator, would make the patient inappropriate for enrollment&#xD;
&#xD;
          -  Metastases in the brain or active epidural disease (NOTE: patients with treated&#xD;
             epidural disease are allowed)&#xD;
&#xD;
          -  Platelet count &lt; 75,000/uL&#xD;
&#xD;
          -  Prothrombin time (PT) or international normalized ratio (INR) and a partial&#xD;
             thromboplastin time PTT &gt; 1.5 times the institutional upper limit of normal (ULN)&#xD;
&#xD;
          -  Structurally unstable bone lesions suggesting impending fracture&#xD;
&#xD;
          -  Previous treatment with MDV3100, ARN-509, or BMS-641988&#xD;
&#xD;
          -  Medical contraindications to stopping aspirin, Coumadin or other anticoagulants for 1&#xD;
             week prior to image-guided tumor biopsies&#xD;
&#xD;
          -  Plans to initiate treatment with an investigational agent while on study prior to&#xD;
             discontinuation of MDV3100 treatment&#xD;
&#xD;
          -  A second active malignancy except adequately treated non-melanoma skin cancer or other&#xD;
             non-invasive or in situ neoplasm&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshi Alumkal</last_name>
    <role>Principal Investigator</role>
    <affiliation>OHSU Knight Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA / Jonsson Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Medical Center-Mount Zion</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OHSU Knight Cancer Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>September 24, 2020</last_update_submitted>
  <last_update_submitted_qc>September 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>OHSU Knight Cancer Institute</investigator_affiliation>
    <investigator_full_name>Tom Beer</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02228265
org study id: IRB00009259
secondary id: NCI-2014-01438
secondary id: MR00046920
secondary id: IRB00009259
nct id: NCT02228265
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This research trial studies molecular features and pathways in predicting drug resistance in
      patients with castration-resistant prostate cancer that has spread to other parts of the body
      and who are receiving enzalutamide. Studying samples of blood and tissue in the laboratory
      from patients receiving enzalutamide may help doctors learn more about molecular features and
      pathways that may cause prostate cancer to be resistant to the drug.
PRIMARY OBJECTIVES:

      I. To assess the correlations between baseline molecular features and pathways and
      prostate-specific antigen (PSA) response (</>= 50% decline) at 12 weeks versus (vs.)
      baseline.

      SECONDARY OBJECTIVES:

      I. To assess the correlations between the baseline molecular features and pathways and
      progression-free survival (defined as time from day 1 of study drug treatment to date of
      radiographic progression or clinical progression), disease-specific survival (defined as the
      time from day 1 of study drug to date of death from prostate cancer), and overall survival
      (defined as time from day 1 of study drug treatment to date of death from any cause).

      II. To assess the correlations between the baseline molecular features and pathways and time
      to PSA progression.

      III. To identify molecular features and cellular pathways present in tumors from men with
      metastatic castrate-resistant prostate cancer (CRPC) that are progressing despite
      enzalutamide treatment.

      IV. To explore correlation between baseline molecular features and pathways and objective
      response.

      V. To assess the correlations between the baseline molecular features and pathways and degree
      of PSA decline at 12 weeks and maximal PSA decline observed while on study.

      VI. To assess the correlations between the baseline molecular features and time on treatment.

      TERTIARY OBJECTIVES:

      I. To assess correlations between cell-free deoxyribonucleic acid (cfDNA) molecular features
      from blood and molecular features and pathways from the biopsy samples.

      II. To assess correlations between cfDNA molecular features and endpoints in the primary and
      secondary objectives listed above.

      III. To explore correlations with baseline molecular features and tissue histology.

      IV. To explore correlations with baseline tissue histology and PSA change, time to PSA
      progression, time on treatment, progression-free survival, and overall survival.

      OUTLINE:

      Patients undergo collection of blood and tissue samples at baseline, during administration of
      enzalutamide, and after the time of disease progression for analysis via
      immunohistochemistry, comparative genome hybridization, and sequencing.

      After completion of study, patients are followed up every 12 weeks.
observational model: Case-Only
time perspective: Prospective
measure: PSA response, a binary variable indicating whether the PSA level has declined >= 50% within 12 weeks of beginning enzalutamide treatment
time frame: Within 12 weeks
description: Will be reported with 95% exact confidence interval.
measure: Degree of PSA decline
time frame: 12 weeks
description: Simple linear regression will be used to assess the association between molecular biomarker predictors and the continuous endpoints. Logarithm transformation or other forms of transformation may be conducted to the continuous endpoints to address the skewedness of the distributions if necessary.
measure: Disease-specific survival
time frame: Time from day 1 of the study drug to date of death from prostate cancer, assessed up to 4 years
description: Will be graphically illustrated using Kaplan-Meier plots of estimated survival distribution for patients (</>= 50%) PSA decline at 12 weeks. Log-rank test will be fitted to determine whether the estimated survival distribution of each time-to-event endpoint differs for patients with PSA decline >= 50% versus patients with PSA decline < 50%. Cox regression models will be fitted to obtain the estimated hazard ratio for each time-to-event endpoints for patients who had >= 50% PSA decline at 12 weeks versus those who had not.
measure: Maximal PSA decline observed while on study
time frame: Up to 4 years
description: Simple linear regression will be used to assess the association between molecular biomarker predictors and the continuous endpoints. Logarithm transformation or other forms of transformation may be conducted to the continuous endpoints to address the skewedness of the distributions if necessary.
measure: Molecular features
time frame: Up to 4 years
description: Will assess correlations between the baseline molecular features and time on treatment.
measure: Objective response
time frame: Up to 4 years
description: Will be summarized using the estimated proportion and 95% confidence interval. Simple logistic regression model will be used to assess the association between molecular biomarker predictors and these binary secondary endpoints.
measure: Overall survival
time frame: Time from day 1 of study drug treatment to date of death from any cause, assessed up to 4 years
description: Will be graphically illustrated using Kaplan-Meier plots of estimated survival distribution for patients (</>= 50%) PSA decline at 12 weeks. Log-rank test will be fitted to determine whether the estimated survival distribution of each time-to-event endpoint differs for patients with PSA decline >= 50% versus patients with PSA decline < 50%. Cox regression models will be fitted to obtain the estimated hazard ratio for each time-to-event endpoints for patients who had >= 50% PSA decline at 12 weeks versus those who had not.
measure: Progression for a subgroup of patients who have metastatic castration resistant prostate cancer and have received enzalutamide treatment
time frame: Up to 4 years
description: Will be summarized using the estimated proportion and 95% confidence interval. Simple logistic regression model will be used to assess the association between molecular biomarker predictors and these binary secondary endpoints.
measure: Progression-free survival
time frame: Time from day 1 of study drug treatment to date of first documented radiographic progression or clinical progression, assessed up to 4 years
description: Will be graphically illustrated using Kaplan-Meier plots of estimated survival distribution for patients (</>= 50%) PSA decline at 12 weeks. Log-rank test will be fitted to determine whether the estimated survival distribution of each time-to-event endpoint differs for patients with PSA decline >= 50% versus patients with PSA decline < 50%. Cox regression models will be fitted to obtain the estimated hazard ratio for each time-to-event endpoints for patients who had >= 50% PSA decline at 12 weeks versus those who had not.
measure: Time to PSA progression
time frame: Up to 4 years
description: Will be graphically illustrated using Kaplan-Meier plots of estimated survival distribution for patients (</>= 50%) PSA decline at 12 weeks. Log-rank test will be fitted to determine whether the estimated survival distribution of each time-to-event endpoint differs for patients with PSA decline >= 50% versus patients with PSA decline < 50%. Cox regression models will be fitted to obtain the estimated hazard ratio for each time-to-event endpoints for patients who had >= 50% PSA decline at 12 weeks versus those who had not.
arm group label: Ancillary-Correlative (genetic analysis)
description: Patients undergo collection of blood and tissue samples at baseline, during administration of enzalutamide and after the time of disease progression for analysis via immunohistochemistry, comparative genome hybridization, and sequencing.
intervention type: Other
intervention name: Cytology Specimen Collection Procedure
description: Undergo blood and tissue collection
arm group label: Ancillary-Correlative (genetic analysis)
other name: Cytologic Sampling
intervention type: Drug
intervention name: Enzalutamide
description: Given PO
arm group label: Ancillary-Correlative (genetic analysis)
other name: ASP9785
other name: MDV3100
other name: Xtandi
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Ancillary-Correlative (genetic analysis)
Tissue and blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Joshi Alumkal
role: Principal Investigator
affiliation: OHSU Knight Cancer Institute
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: OHSU Knight Cancer Institute
investigator full name: Tom Beer
investigator title: Principal Investigator
mesh term: Carcinoma
mesh term: Prostatic Neoplasms