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/NCT05998278</url>
    </required_header>
    <id_info>
      <org_study_id>2022WSJK030</org_study_id>
      <nct_id>NCT05998278</nct_id>
    </id_info>
    <brief_title>Personalized Optimization of Systematic Prostate Biopsy</brief_title>
    <official_title>Research on Building &quot;3+12-X&quot; Personalized Prostate Precise Puncture Model With DRS Layered as the Core Based on Big Data MRI Images</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fujian Medical University Union Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fujian Medical University Union Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Targeted biopsy combined systematic biopsy is the gold standard for diagnosis of prostate&#xD;
        cancer. Excessive cores in systematic biopsy increases the risk of puncture trauma， bleeding&#xD;
        and infection. On the basis of establishing a model with DRS stratification to reduce the&#xD;
        cores of systematic biopsy, we propose the (12 cores -x) model innovatively. We hope that&#xD;
        through this prospective study to verify the efficacy of the model and provide patients with&#xD;
        a new biopsy model with high accuracy and fewer complications.&#xD;
  &#xD;
        In this study， patients with suspected prostate cancer were randomly divided into two groups.&#xD;
        Experimental group received targeted biopsy combined personalized systematic biopsy, and the&#xD;
        control group received targeted biopsy combined systematic biopsy. The differences of the&#xD;
        detection rate of Prostate cancer between the two groups were compared.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, patients with suspected prostate cancer were were enrolled at our institution,&#xD;
        a public referral tertiary center. After written consent was obtained， patients were randomly&#xD;
        assigned to either the intervention or control group in a 1:1 ratio using SPSS software by a&#xD;
        research nurse with no clinical involvement in the trial. Once the allocation was&#xD;
        established, neither patients nor investigators, including the member of the study who&#xD;
        collected the data related to infectious events later, were blinded. Prior to biopsy, the&#xD;
        following patient characteristics were obtained: age, BMI, serum PSA levels, location and&#xD;
        size of the region of interest, and PIRADS-V2 score. Biopsy was performed by an experienced&#xD;
        urologist using standard transperineal technique. The patient was placed in lithotomy&#xD;
        position. After the ultrasound probe was inserted through the rectum, 10ml of 5% lidocaine&#xD;
        was injected into the prostate capsule and apex under ultrasound guidance. Patients assigned&#xD;
        to the experimental group were informed of the personalized systematic biopsy combined with&#xD;
        targeted biopsy using the (12 cores -x) model&#xD;
        (https://daringsky.shinyapps.io/prediction_v2/)， and the control group received targeted&#xD;
        biopsy combined systematic biopsy. A biopsy core was obtained using an 18-gauge 25cm needle&#xD;
        and a spring needle biopsy gun. The primary endpoint was the rate of prostate cancer&#xD;
        diagnosis, including clinically significant cases. The secondary endpoints included pain&#xD;
        scores and complications such as hematuria, perineal hematoma, urinary tract infection, and&#xD;
        urinary retention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 23, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2025</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>
      <intervention_model_description>They were randomly divided into two groups. One group received targeted biopsy plus systematic biopsy. The other group received targeted biopsy plus plus personalized systematic biopsy.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The detection rate of prostate cancer.</measure>
      <time_frame>3 months after biopsy</time_frame>
      <description>According to the pathological results after biopsy, the detection rate of prostate cancer was calculated.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">664</enrollment>
    <condition>Prostate Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Experimental group received targeted biopsy plus personalized systematic biopsy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control group received targeted biopsy plus systematic biopsy</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Personalized Optimization of Systematic Prostate Biopsy</intervention_name>
      <description>Login the model based on our previous study (https://daringsky.shinyapps.io/prediction_v2/) allows for input of age, BMI, serum PSA, size and location of suspicious lesions, PIRADS - V2 score, and prostate volume to generate an individualized needle distribution map,then targeted biopsy combined personalized optimization of systematic prostate biopsy was performed.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with lesions found on rectal examination with any PSA value;&#xD;
  &#xD;
            2. Patients with abnormal lesions found on imaging with any PSA value;&#xD;
  &#xD;
            3. PSA &gt;10.0 ng.ml-1;&#xD;
  &#xD;
            4. Patients with PSA of 4.0-10.0 ng.ml-1 and fPSA/tPSA &lt; 0.16; (5 ) mpMRI was performed&#xD;
               prior to biopsy and Prostate Imaging Reporting and Data System (PI-RADS V2.1)&#xD;
               assessment category ≥3&#xD;
  &#xD;
          (6) Willing to truthfully fill in the subject survey scale; (7) Willing to undergo&#xD;
          follow-up; (8) The patient himself or his authorized immediate family member has signed the&#xD;
          informed consent for clinical trial.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. previous biopsy cases;&#xD;
  &#xD;
            2. Patients who have undergone prostate-related surgery, radiotherapy, or anti-androgen&#xD;
               therapy;&#xD;
  &#xD;
            3. Patients whopresented with severe hemorrhoids or rectal stenosis, rendering them&#xD;
               intolerant to transrectal ultrasound&#xD;
  &#xD;
            4. clotting disordersPatients with severe systemic diseases, such as cardiovascular and&#xD;
               cerebrovascular disorders, are not appropriate candidates for surgical intervention.&#xD;
  &#xD;
            5. unable to follow the plan.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zhenlin Chen</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Urology, Fujian Union Hospital, Fujian Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jiabing Zheng</last_name>
      <phone>+8613799422519</phone>
      <email>xhyykjk@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Urology, Fujian Union Hospital, Fujian Medical University</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <zip>350000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jiabing Zheng</last_name>
        <phone>+8613799422519</phone>
        <email>xhyykjk@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Chen Z, Qu M, Shen X, Jiang S, Zhang W, Ji J, Wang Y, Zhang J, Chen Z, Lin L, Li M, Wu C, Gao X. Establishment of an Individualized Predictive Model to Reduce the Core Number for Systematic Prostate Biopsy: A Dual Center Study Based on Stratification of the Disease Risk Score. Front Oncol. 2022 Feb 14;11:831603. doi: 10.3389/fonc.2021.831603. eCollection 2021.</citation>
      <PMID>35237503</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 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>Adenocarcinoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05998278
  org study id: 2022WSJK030
  nct id: NCT05998278
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Targeted biopsy combined systematic biopsy is the gold standard for diagnosis of prostate
        cancer. Excessive cores in systematic biopsy increases the risk of puncture trauma， bleeding
        and infection. On the basis of establishing a model with DRS stratification to reduce the
        cores of systematic biopsy, we propose the (12 cores -x) model innovatively. We hope that
        through this prospective study to verify the efficacy of the model and provide patients with
        a new biopsy model with high accuracy and fewer complications.
  
        In this study， patients with suspected prostate cancer were randomly divided into two groups.
        Experimental group received targeted biopsy combined personalized systematic biopsy, and the
        control group received targeted biopsy combined systematic biopsy. The differences of the
        detection rate of Prostate cancer between the two groups were compared.
  In this study, patients with suspected prostate cancer were were enrolled at our institution,
        a public referral tertiary center. After written consent was obtained， patients were randomly
        assigned to either the intervention or control group in a 1:1 ratio using SPSS software by a
        research nurse with no clinical involvement in the trial. Once the allocation was
        established, neither patients nor investigators, including the member of the study who
        collected the data related to infectious events later, were blinded. Prior to biopsy, the
        following patient characteristics were obtained: age, BMI, serum PSA levels, location and
        size of the region of interest, and PIRADS-V2 score. Biopsy was performed by an experienced
        urologist using standard transperineal technique. The patient was placed in lithotomy
        position. After the ultrasound probe was inserted through the rectum, 10ml of 5% lidocaine
        was injected into the prostate capsule and apex under ultrasound guidance. Patients assigned
        to the experimental group were informed of the personalized systematic biopsy combined with
        targeted biopsy using the (12 cores -x) model
        (https://daringsky.shinyapps.io/prediction_v2/)， and the control group received targeted
        biopsy combined systematic biopsy. A biopsy core was obtained using an 18-gauge 25cm needle
        and a spring needle biopsy gun. The primary endpoint was the rate of prostate cancer
        diagnosis, including clinically significant cases. The secondary endpoints included pain
        scores and complications such as hematuria, perineal hematoma, urinary tract infection, and
        urinary retention.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: They were randomly divided into two groups. One group received targeted biopsy plus systematic biopsy. The other group received targeted biopsy plus plus personalized systematic biopsy.
  primary purpose: Diagnostic
  masking: Single (Participant)
  measure: The detection rate of prostate cancer.
  time frame: 3 months after biopsy
  description: According to the pathological results after biopsy, the detection rate of prostate cancer was calculated.
  arm group label: Experimental group
  arm group type: Experimental
  description: Experimental group received targeted biopsy plus personalized systematic biopsy
  arm group label: Control group
  arm group type: No Intervention
  description: Control group received targeted biopsy plus systematic biopsy
  intervention type: Procedure
  intervention name: Personalized Optimization of Systematic Prostate Biopsy
  description: Login the model based on our previous study (https://daringsky.shinyapps.io/prediction_v2/) allows for input of age, BMI, serum PSA, size and location of suspicious lesions, PIRADS - V2 score, and prostate volume to generate an individualized needle distribution map,then targeted biopsy combined personalized optimization of systematic prostate biopsy was performed.
  arm group label: Experimental group
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 50 Years
  maximum age: 95 Years
  healthy volunteers: No
  last name: Zhenlin Chen
  role: Principal Investigator
  affiliation: Department of Urology, Fujian Union Hospital, Fujian Medical University
  last name: Jiabing Zheng
  phone: +8613799422519
  email: xhyykjk@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Chen Z, Qu M, Shen X, Jiang S, Zhang W, Ji J, Wang Y, Zhang J, Chen Z, Lin L, Li M, Wu C, Gao X. Establishment of an Individualized Predictive Model to Reduce the Core Number for Systematic Prostate Biopsy: A Dual Center Study Based on Stratification of the Disease Risk Score. Front Oncol. 2022 Feb 14;11:831603. doi: 10.3389/fonc.2021.831603. eCollection 2021.
  PMID: 35237503
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  sharing ipd: No