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/NCT05969704</url>
    </required_header>
    <id_info>
      <org_study_id>TRUS prostatic biopsy</org_study_id>
      <nct_id>NCT05969704</nct_id>
    </id_info>
    <brief_title>Fusion Versus Cognitive MRI Targeted Prostatic Biopsy</brief_title>
    <official_title>Magnetic Resonance Imaging Targeted (Fusion) Versus Cognitive Prostatic Biopsy in Biopsy-naïve Suspected Cancer Prostate Patient A Comparison Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Menoufia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Menoufia University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the present study is to compare the accuracy of Magnetic resonance imaging&#xD;
        targeted (fusion) versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate&#xD;
        patient&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Prostate cancer is the second most frequent malignancy (after lung cancer) in men worldwide,&#xD;
        counting 1,276,106 new cases and causing 358,989 deaths (3.8% of all deaths caused by cancer&#xD;
        in men.&#xD;
  &#xD;
        The clinical prostate cancer detection rate of TRUS-guided needle biopsies is only 25-30%.&#xD;
        while more than 50% of cancers that require definitive treatment remain undetected during&#xD;
        initial biopsies .&#xD;
  &#xD;
        Clinical studies have shown that 75-80% of non-palpable carcinomas remain undetected during&#xD;
        initial prostate biopsies.&#xD;
  &#xD;
        Multi-parametric prostate MRI has a high sensitivity for the detection of prostate&#xD;
        adenocarcinoma and has shown promise for targeted biopsy of lesions that may be missed on&#xD;
        routine systematic trans -rectal ultrasound (TRUS) biopsy .&#xD;
  &#xD;
        The most recent European Association of Urology guidelines recommend MRI before prostate&#xD;
        biopsy for biopsy-naïve men with elevated PSA, the strength rating of the recommendation is&#xD;
        weak.&#xD;
  &#xD;
        A systematic 12-core trans-rectal ultrasound-guided systematic biopsy (TRUS-SB) is still&#xD;
        carried out for biopsy-naïve men at present. However, the TRUS-SB technique has several&#xD;
        limitations, including over-diagnosis of clinically insignificant prostate cancer (CISCa),&#xD;
        under-diagnosis of clinically significant prostate cancer (CSCa), false negative biopsy&#xD;
        results and biopsy-related complications, such as bleeding and infections .&#xD;
  &#xD;
        Targeted prostate biopsies from MRI-suspicious lesions have been shown to improve the cancer&#xD;
        detection rate (CDR) of CSCa compared with systematic TRUS-guided biopsies .&#xD;
  &#xD;
        Currently, three biopsy techniques are used for TB from MRI-suspicious lesions: in-bore MRI&#xD;
        biopsies, cognitive magnetic resonance imaging trans-rectal ultrasound fusion targeted biopsy&#xD;
        (COG-TB) and software guided magnetic resonance imaging-ultrasound fusion targeted biopsies&#xD;
        (MRUS-TB). Inbore MRI biopsies that are carried out with an MRI-compatible guidance device&#xD;
        can target suspicious lesions accurately; however, such biopsies are time-consuming and&#xD;
        expensive .&#xD;
  &#xD;
        In the COG-TB technique, a physician samples a location that has been visually estimated&#xD;
        using ultrasound and is considered to correspond to the location of a suspicious lesion that&#xD;
        was detected on MRI. However, when the suspicious lesion is completely invisible (isoechoic&#xD;
        or too small) on TRUS, the accuracy of such biopsies is likely reduced .&#xD;
  &#xD;
        The accuracy of COG-TB might be influenced by multiple factors, including the alignment of&#xD;
        prostate landmarks, the physician's experience and so on. for these reasons, MRUS-TB where&#xD;
        software fuses the MRI images with real-time TRUS images to guide the operator to biopsy the&#xD;
        suspicious lesions is more commonly carried out; however, the optimal TB method remains&#xD;
        unclear.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>detection of clinically significant prostate cancer</measure>
      <time_frame>two weeks</time_frame>
      <description>accuracy of MRI targeted fusion versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient to detect clinically significant prostate cancer</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">33</enrollment>
    <condition>Prostatic Cancer</condition>
    <arm_group>
      <arm_group_label>fusion biopsy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This biopsy procedure that combines the pictures from an MRI and an ultrasound to create a detailed 3-D image of the prostate. This procedure makes it easier to see an abnormal area of prostate in order to guide the biopsy needle into the abnormal area. A sample of tissue can then be taken and checked under a microscope for cancer. A fusion biopsy may help find prostate cancer cells that may be missed with other types of biopsies. It may help find cancer at an early stage and plan cancer treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>cognitive biopsy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>the biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and of the lesion within it to take a biopsy from it</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>MRI fusion targeted prostatic biopsy</intervention_name>
      <description>combines the pictures from an MRI and an ultrasound to create a detailed 3-D image of the prostate. This procedure makes it easier to see an abnormal lesion of prostate in order to guide the biopsy needle into the abnormal lesion</description>
      <arm_group_label>fusion biopsy</arm_group_label>
      <other_name>fusion biopsy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>MRI cognitive targeted prostatic biopsy</intervention_name>
      <description>the biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and of the lesion within it to take a biopsy from the lesion</description>
      <arm_group_label>cognitive biopsy</arm_group_label>
      <other_name>cognitive biposy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  prostate biopsy-naïve men&#xD;
  &#xD;
            -  PSA levels of up to 20 ng/mL&#xD;
  &#xD;
            -  Multi-parametric prostate MRI revealed a PIRAD 4 or PIRAD 5.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  PSA level greater than 20 ng/mL&#xD;
  &#xD;
            -  patient with history of TRUS biopsy&#xD;
  &#xD;
            -  patient diagnosed as cancer prostate or with distant metastasis&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ahmed M Mehanna</last_name>
      <phone>201026906035</phone>
      <email>ahmedmehana1994@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mohammed I Abuzaid</last_name>
      <phone>201068588750</phone>
      <email>Mabuzaid84@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Menoufia University Hospital</name>
        <address>
          <city>Shibin Al Kawm</city>
          <state>Menoufia</state>
          <zip>13829</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ahmed A Gamal Eldin, professor</last_name>
        <phone>201005207564</phone>
        <email>agamaleldeen@yahoo.com</email>
      </contact>
      <contact_backup>
        <last_name>Mohammed K Omar, assistant professor</last_name>
        <phone>201066949454</phone>
        <email>KIMO_81eg@yahoo.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Menoufia University</investigator_affiliation>
      <investigator_full_name>Ahmed Mohamed Shebl Mehanna</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <keyword>fusion biopsy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05969704
  org study id: TRUS prostatic biopsy
  nct id: NCT05969704
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the present study is to compare the accuracy of Magnetic resonance imaging
        targeted (fusion) versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate
        patient
  Prostate cancer is the second most frequent malignancy (after lung cancer) in men worldwide,
        counting 1,276,106 new cases and causing 358,989 deaths (3.8% of all deaths caused by cancer
        in men.
  
        The clinical prostate cancer detection rate of TRUS-guided needle biopsies is only 25-30%.
        while more than 50% of cancers that require definitive treatment remain undetected during
        initial biopsies .
  
        Clinical studies have shown that 75-80% of non-palpable carcinomas remain undetected during
        initial prostate biopsies.
  
        Multi-parametric prostate MRI has a high sensitivity for the detection of prostate
        adenocarcinoma and has shown promise for targeted biopsy of lesions that may be missed on
        routine systematic trans -rectal ultrasound (TRUS) biopsy .
  
        The most recent European Association of Urology guidelines recommend MRI before prostate
        biopsy for biopsy-naïve men with elevated PSA, the strength rating of the recommendation is
        weak.
  
        A systematic 12-core trans-rectal ultrasound-guided systematic biopsy (TRUS-SB) is still
        carried out for biopsy-naïve men at present. However, the TRUS-SB technique has several
        limitations, including over-diagnosis of clinically insignificant prostate cancer (CISCa),
        under-diagnosis of clinically significant prostate cancer (CSCa), false negative biopsy
        results and biopsy-related complications, such as bleeding and infections .
  
        Targeted prostate biopsies from MRI-suspicious lesions have been shown to improve the cancer
        detection rate (CDR) of CSCa compared with systematic TRUS-guided biopsies .
  
        Currently, three biopsy techniques are used for TB from MRI-suspicious lesions: in-bore MRI
        biopsies, cognitive magnetic resonance imaging trans-rectal ultrasound fusion targeted biopsy
        (COG-TB) and software guided magnetic resonance imaging-ultrasound fusion targeted biopsies
        (MRUS-TB). Inbore MRI biopsies that are carried out with an MRI-compatible guidance device
        can target suspicious lesions accurately; however, such biopsies are time-consuming and
        expensive .
  
        In the COG-TB technique, a physician samples a location that has been visually estimated
        using ultrasound and is considered to correspond to the location of a suspicious lesion that
        was detected on MRI. However, when the suspicious lesion is completely invisible (isoechoic
        or too small) on TRUS, the accuracy of such biopsies is likely reduced .
  
        The accuracy of COG-TB might be influenced by multiple factors, including the alignment of
        prostate landmarks, the physician's experience and so on. for these reasons, MRUS-TB where
        software fuses the MRI images with real-time TRUS images to guide the operator to biopsy the
        suspicious lesions is more commonly carried out; however, the optimal TB method remains
        unclear.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Single (Participant)
  measure: detection of clinically significant prostate cancer
  time frame: two weeks
  description: accuracy of MRI targeted fusion versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient to detect clinically significant prostate cancer
  arm group label: fusion biopsy
  arm group type: Active Comparator
  description: This biopsy procedure that combines the pictures from an MRI and an ultrasound to create a detailed 3-D image of the prostate. This procedure makes it easier to see an abnormal area of prostate in order to guide the biopsy needle into the abnormal area. A sample of tissue can then be taken and checked under a microscope for cancer. A fusion biopsy may help find prostate cancer cells that may be missed with other types of biopsies. It may help find cancer at an early stage and plan cancer treatment.
  arm group label: cognitive biopsy
  arm group type: Active Comparator
  description: the biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and of the lesion within it to take a biopsy from it
  intervention type: Procedure
  intervention name: MRI fusion targeted prostatic biopsy
  description: combines the pictures from an MRI and an ultrasound to create a detailed 3-D image of the prostate. This procedure makes it easier to see an abnormal lesion of prostate in order to guide the biopsy needle into the abnormal lesion
  arm group label: fusion biopsy
  other name: fusion biopsy
  intervention type: Procedure
  intervention name: MRI cognitive targeted prostatic biopsy
  description: the biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and of the lesion within it to take a biopsy from the lesion
  arm group label: cognitive biopsy
  other name: cognitive biposy
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Ahmed M Mehanna
  phone: 201026906035
  email: ahmedmehana1994@gmail.com
  last name: Mohammed I Abuzaid
  phone: 201068588750
  email: Mabuzaid84@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Menoufia University
  investigator full name: Ahmed Mohamed Shebl Mehanna
  investigator title: Doctor
  mesh term: Prostatic Neoplasms
  sharing ipd: Undecided