xml: <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/NCT06024772</url>
    </required_header>
    <id_info>
      <org_study_id>iRISID-2022-1191</org_study_id>
      <nct_id>NCT06024772</nct_id>
    </id_info>
    <brief_title>Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer in Adult Men With Suspected Prostate Cancer</brief_title>
    <official_title>Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Thomas Jefferson University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Thomas Jefferson University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This phase III trial compares the use of contrast-enhanced multiparametric ultrasound (mp-US)&#xD;
        to multiparametric magnetic resonance imaging (mp-MRI) for the diagnosis of clinically&#xD;
        significant prostate cancer (PCa). A mp-US is a procedure in which a probe that sends out&#xD;
        high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal&#xD;
        tissues or organs and make echoes. The echoes form a picture of body tissue called a&#xD;
        sonogram. Perflutren lipid michrosphere (Definity) is a contrast agent that uses microbubbles&#xD;
        to enhance ultrasound images of the prostate. Doctors hope to learn if the Definity-enhanced&#xD;
        mp-US imaging technique can accurately direct targeted biopsy for the detection of clinically&#xD;
        significant prostate cancer when compared to standard of care mp-MRI.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To demonstrate non-inferiority between the detection rate of clinically significant PCa&#xD;
        with 3-dimensional (3D) mp-US + systematic biopsy compared to the detection rate of mp-MRI +&#xD;
        systematic biopsy.&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To demonstrate non-inferiority of a biopsy approach utilizing targeted biopsy cores based&#xD;
        on mp-US compared with targeted biopsy based on mp-MRI, for detection of clinically&#xD;
        significant PCa.&#xD;
  &#xD;
        II. To construct an optimal logistic regression model to predict the presence of clinically&#xD;
        significant PCa based on the mp-US elements as well as the prostate specific antigen (PSA),&#xD;
        PSA velocity and any other biological variables (e.g., age).&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        Patients undergo mp-MRI, receive Definity intravenously (IV), and undergo transrectal mp-US&#xD;
        and prostate biopsies on study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">February 2026</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <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>Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Will compare PCa detection rate of 3D mp-US combined with systematic biopsy to detection rate of multiparametric magnetic resonance imaging (mp-MRI) combined with systematic biopsy. Will evaluate paired biopsy data for non-inferiority and superiority endpoints, comparing the detection rate of clinically significant PCa with mp-US + systematic biopsy to the detection rate of mp-MRI + systematic biopsy. This analysis will be repeated using both definitions of clinically significant PCa. Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, standard deviation (SD), median, and range.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PCa detection rate of 3D mp-US</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, SD, median, and range. Continuous data will be analyzed using t-tests, or log-rank tests if data are not normally distributed. Variance is expressed through 95% confidence intervals and a significance level of 5% with Bonferroni correction for multiple comparisons will be used to control the group-wise error of the study for individual comparisons.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Accuracy of PCa detection by biopsy using the optimal logistical model based around mp-US compared to the optimal logistical model based around mp-MRI</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Will evaluate the accuracty of the optimal logistic model combining the mp-US elements as well as the prostate specific antigen, prostate specific antigen velocity and other biological variables.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Prostate Carcinoma</condition>
    <arm_group>
      <arm_group_label>Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ultiparametric Magnetic Resonance Imaging</intervention_name>
      <description>Undergo mp-MRI</description>
      <arm_group_label>Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)</arm_group_label>
      <other_name>MP-MRI</other_name>
      <other_name>mpMRI</other_name>
      <other_name>Multi-parametric MRI</other_name>
      <other_name>Multiparametric MRI</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Perflutren lipid microsphere</intervention_name>
      <description>Given IV</description>
      <arm_group_label>Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)</arm_group_label>
      <other_name>Definity</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Transrectal Ultrasound</intervention_name>
      <description>Undergo transrectal mp-US</description>
      <arm_group_label>Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)</arm_group_label>
      <other_name>endorectal ultrasound</other_name>
      <other_name>ERUS</other_name>
      <other_name>TRUS</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Biopsy of Prostate</intervention_name>
      <description>Undergo prostate biopsies</description>
      <arm_group_label>Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)</arm_group_label>
      <other_name>Prostate Biopsy</other_name>
      <other_name>Prostatic Biopsy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject must be scheduled for a prostate biopsy, based on an elevated PSA (&gt; 3.0ng/ml)&#xD;
               per most recent National Comprehensive Cancer Network (NCCN) guidelines, elevated PSA&#xD;
               velocity (&gt; 0.75ng/ml/year), or abnormal digital rectal examination&#xD;
  &#xD;
            -  Subject must be able and willing to give written informed consent for a contrast&#xD;
               enhanced ultrasound study of the prostate including the additional study biopsies&#xD;
  &#xD;
            -  Subject must be a male at least 18 years of age when informed consent is obtained&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant in a clinical trial involving an investigational drug within the past 30&#xD;
               days&#xD;
  &#xD;
            -  Patients with known or suspected hypersensitivity to perflutren, polyethylene glycol&#xD;
               (PEG), or any other component of Definity&#xD;
  &#xD;
            -  Previous treatment for prostate cancer, including hormone therapy&#xD;
  &#xD;
            -  Clinically unstable, severely ill, or moribund as per treating physician&#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_contact>
      <last_name>Flemming Forsberg, PhD</last_name>
      <phone>215-955-4870</phone>
      <email>Flemming.Forsberg@jefferson.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sidney Kimmel Cancer Center at Thomas Jefferson University</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19107</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Flemming Forsberg, PhD</last_name>
        <phone>215-955-4870</phone>
        <email>Flemming.Forsberg@jefferson.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</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>
  
  
text: 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/NCT06024772
  org study id: iRISID-2022-1191
  nct id: NCT06024772
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This phase III trial compares the use of contrast-enhanced multiparametric ultrasound (mp-US)
        to multiparametric magnetic resonance imaging (mp-MRI) for the diagnosis of clinically
        significant prostate cancer (PCa). A mp-US is a procedure in which a probe that sends out
        high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal
        tissues or organs and make echoes. The echoes form a picture of body tissue called a
        sonogram. Perflutren lipid michrosphere (Definity) is a contrast agent that uses microbubbles
        to enhance ultrasound images of the prostate. Doctors hope to learn if the Definity-enhanced
        mp-US imaging technique can accurately direct targeted biopsy for the detection of clinically
        significant prostate cancer when compared to standard of care mp-MRI.
  PRIMARY OBJECTIVE:
  
        I. To demonstrate non-inferiority between the detection rate of clinically significant PCa
        with 3-dimensional (3D) mp-US + systematic biopsy compared to the detection rate of mp-MRI +
        systematic biopsy.
  
        SECONDARY OBJECTIVES:
  
        I. To demonstrate non-inferiority of a biopsy approach utilizing targeted biopsy cores based
        on mp-US compared with targeted biopsy based on mp-MRI, for detection of clinically
        significant PCa.
  
        II. To construct an optimal logistic regression model to predict the presence of clinically
        significant PCa based on the mp-US elements as well as the prostate specific antigen (PSA),
        PSA velocity and any other biological variables (e.g., age).
  
        OUTLINE:
  
        Patients undergo mp-MRI, receive Definity intravenously (IV), and undergo transrectal mp-US
        and prostate biopsies on study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy
  time frame: Up to 2 years
  description: Will compare PCa detection rate of 3D mp-US combined with systematic biopsy to detection rate of multiparametric magnetic resonance imaging (mp-MRI) combined with systematic biopsy. Will evaluate paired biopsy data for non-inferiority and superiority endpoints, comparing the detection rate of clinically significant PCa with mp-US + systematic biopsy to the detection rate of mp-MRI + systematic biopsy. This analysis will be repeated using both definitions of clinically significant PCa. Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, standard deviation (SD), median, and range.
  measure: PCa detection rate of 3D mp-US
  time frame: Up to 2 years
  description: Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, SD, median, and range. Continuous data will be analyzed using t-tests, or log-rank tests if data are not normally distributed. Variance is expressed through 95% confidence intervals and a significance level of 5% with Bonferroni correction for multiple comparisons will be used to control the group-wise error of the study for individual comparisons.
  measure: Accuracy of PCa detection by biopsy using the optimal logistical model based around mp-US compared to the optimal logistical model based around mp-MRI
  time frame: Up to 2 years
  description: Will evaluate the accuracty of the optimal logistic model combining the mp-US elements as well as the prostate specific antigen, prostate specific antigen velocity and other biological variables.
  arm group label: Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)
  arm group type: Experimental
  description: Patients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies on study.
  intervention type: Procedure
  intervention name: ultiparametric Magnetic Resonance Imaging
  description: Undergo mp-MRI
  arm group label: Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)
  other name: MP-MRI
  other name: mpMRI
  other name: Multi-parametric MRI
  other name: Multiparametric MRI
  intervention type: Drug
  intervention name: Perflutren lipid microsphere
  description: Given IV
  arm group label: Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)
  other name: Definity
  intervention type: Procedure
  intervention name: Transrectal Ultrasound
  description: Undergo transrectal mp-US
  arm group label: Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)
  other name: endorectal ultrasound
  other name: ERUS
  other name: TRUS
  intervention type: Procedure
  intervention name: Biopsy of Prostate
  description: Undergo prostate biopsies
  arm group label: Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)
  other name: Prostate Biopsy
  other name: Prostatic Biopsy
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Flemming Forsberg, PhD
  phone: 215-955-4870
  email: Flemming.Forsberg@jefferson.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms