<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/NCT02237612</url>
  </required_header>
  <id_info>
    <org_study_id>4P-08-4</org_study_id>
    <secondary_id>NCI-2014-01848</secondary_id>
    <secondary_id>HS-08-00413-CR004</secondary_id>
    <secondary_id>HS-08-00413</secondary_id>
    <secondary_id>4P-08-4</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT02237612</nct_id>
  </id_info>
  <brief_title>Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer</brief_title>
  <official_title>Diffusion-Weighted MRI for Staging in Localized Prostate Cancer: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging&#xD;
      (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph&#xD;
      nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI, may&#xD;
      be a less invasive way of predicting the stage and grade of prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the sensitivity and specificity of diffusion-weighted MRI for pathologic T3&#xD;
      stage prostate cancer using a 3 Tesla (3T) magnet with a surface coil.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo diffusion-weighted MRI of the pelvis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI</measure>
    <time_frame>Baseline</time_frame>
    <description>Patients will be imaged using diffusion-weighted MR. Findings will be correlated with histopathologic findings at biopsy and/or prostatectomy.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Adenocarcinoma of the Prostate</condition>
  <condition>Stage IIA Prostate Cancer</condition>
  <condition>Stage IIB Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Diagnostic (diffusion-weighted MRI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo diffusion-weighted MRI of the pelvis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>diffusion-weighted magnetic resonance imaging</intervention_name>
    <description>Undergo diffusion-weighted MRI</description>
    <arm_group_label>Diagnostic (diffusion-weighted MRI)</arm_group_label>
    <other_name>diffusion-weighted MRI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Diagnostic (diffusion-weighted MRI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy-documented adenocarcinoma of the prostate which is intermediate or high risk,&#xD;
             defined as possessing one or more of the following features:&#xD;
&#xD;
               -  Gleason &gt;= 7&#xD;
&#xD;
               -  &gt; 50% biopsy cores +&#xD;
&#xD;
               -  Prostate-specific antigen (PSA) &gt;= 10&#xD;
&#xD;
          -  Interested in undergoing a radical prostatectomy as definitive management for prostate&#xD;
             cancer&#xD;
&#xD;
          -  No clinical or radiographic evidence for distant metastatic disease&#xD;
&#xD;
               -  In subjects with PSA &lt; 20 no radiographic staging is required in the absence of&#xD;
                  clinical symptoms for distant metastatic disease; for those with PSA &gt; 20, a bone&#xD;
                  scan must document lack of concern for bone involvement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ineligible for surgery due to cardiac, pulmonary, or other major comorbidity factor&#xD;
&#xD;
          -  History of claustrophobia&#xD;
&#xD;
          -  Pacemaker or other implanted metal objects which would make subject ineligible for&#xD;
             MRI, per standard criteria&#xD;
&#xD;
          -  Unable to give written informed consent&#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>Tanya Dorff</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02237612
org study id: 4P-08-4
secondary id: NCI-2014-01848
secondary id: HS-08-00413-CR004
secondary id: HS-08-00413
secondary id: 4P-08-4
secondary id: P30CA014089
nct id: NCT02237612
lead sponsor: 
collaborator: 
has dmc: No
This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging
      (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph
      nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI, may
      be a less invasive way of predicting the stage and grade of prostate cancer.
PRIMARY OBJECTIVES:

      I. To determine the sensitivity and specificity of diffusion-weighted MRI for pathologic T3
      stage prostate cancer using a 3 Tesla (3T) magnet with a surface coil.

      OUTLINE:

      Patients undergo diffusion-weighted MRI of the pelvis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI
time frame: Baseline
description: Patients will be imaged using diffusion-weighted MR. Findings will be correlated with histopathologic findings at biopsy and/or prostatectomy.
arm group label: Diagnostic (diffusion-weighted MRI)
arm group type: Experimental
description: Patients undergo diffusion-weighted MRI of the pelvis.
intervention type: Procedure
intervention name: diffusion-weighted magnetic resonance imaging
description: Undergo diffusion-weighted MRI
arm group label: Diagnostic (diffusion-weighted MRI)
other name: diffusion-weighted MRI
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Diagnostic (diffusion-weighted MRI)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tanya Dorff
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms