<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/NCT03838432</url>
  </required_header>
  <id_info>
    <org_study_id>BZLC-12-1</org_study_id>
    <nct_id>NCT03838432</nct_id>
  </id_info>
  <brief_title>The Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Ablation Therapy</brief_title>
  <official_title>The Efficacy and Safety of Composite Steep-pulse(High-frequency Irreversible Electroporation) Treatment Apparatus Used in Prostate Cancer Ablation Therapy : a Multicenter, Single-arm, Objective Performance Criteria Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Military Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Military Medical University</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>
      This trial is studying the effects and safety in treating patients from five different&#xD;
      centers with local prostate cancer, employing Composite Steep-pulse(High-frequency&#xD;
      irreversible electroporation) Treatment Apparatus. This device could cause cell irreversible&#xD;
      electroporation, which leading necrosis of tumor cells. It also has the ability to prevent&#xD;
      nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite&#xD;
      Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion&#xD;
      criteria. Safety, quality of life, and histopathological analysis of prostate speciem will be&#xD;
      evaluated in each study patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Prostate cancer is the most common cancer in elderly males in western country. It is also a&#xD;
      major health concern, especially in China with its greater proportion of elderly men in the&#xD;
      general population. Currently, radical prostatectomy(RP) is the mainstream treatment for&#xD;
      localized PCa to show a benefit for cancer-specific survival (CSS). However, the patient who&#xD;
      underwent RP might suffer from the complication of erectile dysfunction or urinary&#xD;
      incontinence. In 2004, a new method using steep pulses to treat tumor was appeared. It showed&#xD;
      that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading&#xD;
      tonecrosis of tumor cells. And it seemed to do no harms to the nerve and Vascular epithelial&#xD;
      cell. The device of steep pulse had already been approved by FDA in 2011.However, this device&#xD;
      of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury;&#xD;
      (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite&#xD;
      Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus, may have the&#xD;
      potential to conquer these disadvantages.&#xD;
&#xD;
      Purpose:&#xD;
&#xD;
        1. This study will assess the efficacy of Composite Steep-pulse(High-frequency irreversible&#xD;
           electroporation) Treatment Apparatus in the treatment of PCa.&#xD;
&#xD;
        2. This study will assess the safety of Composite Steep-pulse(High-frequency irreversible&#xD;
           electroporation) Treatment Apparatus in the treatment of PCa.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
        1. patients recruitment&#xD;
&#xD;
        2. transperineal maping prostate biopsy(&gt;20 needle) guided by transrectal ultrasound(TRUS).&#xD;
&#xD;
        3. Irreversible Electroporation of malignant Tumor Cell under Composite Steep-pulse&#xD;
           Treatment for the patients with positive biopsy;&#xD;
&#xD;
        4. Some factors such as prostate MRI,the maping prostate biopsy(&gt;20 needle),the&#xD;
           histopathological outcomes analysis ect. will be performed to evaluate the efficacy of&#xD;
           the treatment.&#xD;
&#xD;
        5. Other factors such as the routine blood test, the routine urine test, the urinary&#xD;
           continence ect. will be performed to evaluate the safety of the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 2, 2018</start_date>
  <completion_date type="Anticipated">January 18, 2020</completion_date>
  <primary_completion_date type="Actual">September 27, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The result of prostate maping biopsy</measure>
    <time_frame>6 Months</time_frame>
    <description>evaluation of pathological analysis from the biopsy sample to confirm if there remain clinically significant prostate cancer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The result of prostate MRI</measure>
    <time_frame>6 Months</time_frame>
    <description>evaluation of ablation range from prostate MRI to confirm if there remain suspicious lesions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>urinary incontinence</measure>
    <time_frame>6 Months</time_frame>
    <description>The rate of urinary incontinence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urination function(IPSS scoring)</measure>
    <time_frame>6 Months</time_frame>
    <description>evaluation of urination function by IPSS scoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sexual function (IIEF-5 scoring)</measure>
    <time_frame>6 Months</time_frame>
    <description>evaluation of sexual function by IIEF-5 scoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urinary catheter retention time</measure>
    <time_frame>6 Months</time_frame>
    <description>Record of urinary catheter retention time</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">119</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Steep Pulse Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Applying the steep pulse to treat the patients with Prostate cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Steep Pulse Device</intervention_name>
    <description>Applying the steep pulse to treat the patients with Prostate cancer</description>
    <arm_group_label>Steep Pulse Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The therapy must be thoroughtly understood with the agreement signed&#xD;
&#xD;
          2. Prostate MRI can identify negative extracapsular extension and seminal vesicle&#xD;
             involvement,and no evidence of lymphatic metastasis&#xD;
&#xD;
          3. Patients must have confirmed prostate cancer by prostate maping biopsy&#xD;
&#xD;
          4. Low-risk or intermediate risk prostate cancer(PSA&lt;20ng/ml,T1a-T2c,Gleason Score≤7)&#xD;
&#xD;
          5. There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI&#xD;
&#xD;
          6. No prostatic calculus or prostatic calculus≤5mm&#xD;
&#xD;
          7. Age ≥ 40 - ≤ 85 years&#xD;
&#xD;
          8. Life expectancy of greater than 5 years(WHO Performance Status 0-1)&#xD;
&#xD;
          9. Patients with fertility are willing to take contraceptive measures until the end of&#xD;
             the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients have previously undergone radical prostatectomy, hormonal therapy or&#xD;
             radiotherapy.&#xD;
&#xD;
          2. Patients underwent other surgery before less than 3 months.&#xD;
&#xD;
          3. Patients required long-term medication with anticoagulans or stop taking anticoagulans&#xD;
             less than 1 months&#xD;
&#xD;
          4. Patients with clinically significant cardiovascular disease or other serious diseases&#xD;
&#xD;
          5. Patients with metal implants in their bodys(for example,cardiac pacemaker ) and/or&#xD;
             with metal implants which located in the range from the first lumbar vertebra(L1) to&#xD;
             the middle of femurs.&#xD;
&#xD;
          6. Patients with history of epilepsy&#xD;
&#xD;
          7. Patients with other malignant tumor or patients with hiv.&#xD;
&#xD;
          8. Patients with other serious systemic diseases that the study believes may interfere&#xD;
             with the treatment, evaluation, and compliance of the trial;&#xD;
&#xD;
          9. Patients with participation in another clinical trial less than 3 months.&#xD;
&#xD;
         10. Patients with the judge that they are not suitable for this clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Changhai Hospital,Second Military Medical University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>October 18, 2018</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>December 14, 2019</last_update_submitted>
  <last_update_submitted_qc>December 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Second Military Medical University</investigator_affiliation>
    <investigator_full_name>yinghao Sun</investigator_full_name>
    <investigator_title>director, head of uroglogy department, clinical professor</investigator_title>
  </responsible_party>
  <keyword>focal therapy</keyword>
  <keyword>IRE</keyword>
  <keyword>Composite Steep-pulse Treatment Apparatus</keyword>
  <keyword>prostate cancer</keyword>
  <keyword>Multi-center</keyword>
  <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/NCT03838432
org study id: BZLC-12-1
nct id: NCT03838432
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial is studying the effects and safety in treating patients from five different
      centers with local prostate cancer, employing Composite Steep-pulse(High-frequency
      irreversible electroporation) Treatment Apparatus. This device could cause cell irreversible
      electroporation, which leading necrosis of tumor cells. It also has the ability to prevent
      nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite
      Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion
      criteria. Safety, quality of life, and histopathological analysis of prostate speciem will be
      evaluated in each study patients.
Background:

      Prostate cancer is the most common cancer in elderly males in western country. It is also a
      major health concern, especially in China with its greater proportion of elderly men in the
      general population. Currently, radical prostatectomy(RP) is the mainstream treatment for
      localized PCa to show a benefit for cancer-specific survival (CSS). However, the patient who
      underwent RP might suffer from the complication of erectile dysfunction or urinary
      incontinence. In 2004, a new method using steep pulses to treat tumor was appeared. It showed
      that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading
      tonecrosis of tumor cells. And it seemed to do no harms to the nerve and Vascular epithelial
      cell. The device of steep pulse had already been approved by FDA in 2011.However, this device
      of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury;
      (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite
      Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus, may have the
      potential to conquer these disadvantages.

      Purpose:

        1. This study will assess the efficacy of Composite Steep-pulse(High-frequency irreversible
           electroporation) Treatment Apparatus in the treatment of PCa.

        2. This study will assess the safety of Composite Steep-pulse(High-frequency irreversible
           electroporation) Treatment Apparatus in the treatment of PCa.

      Methods:

        1. patients recruitment

        2. transperineal maping prostate biopsy(>20 needle) guided by transrectal ultrasound(TRUS).

        3. Irreversible Electroporation of malignant Tumor Cell under Composite Steep-pulse
           Treatment for the patients with positive biopsy;

        4. Some factors such as prostate MRI,the maping prostate biopsy(>20 needle),the
           histopathological outcomes analysis ect. will be performed to evaluate the efficacy of
           the treatment.

        5. Other factors such as the routine blood test, the routine urine test, the urinary
           continence ect. will be performed to evaluate the safety of the treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The result of prostate maping biopsy
time frame: 6 Months
description: evaluation of pathological analysis from the biopsy sample to confirm if there remain clinically significant prostate cancer
measure: The result of prostate MRI
time frame: 6 Months
description: evaluation of ablation range from prostate MRI to confirm if there remain suspicious lesions
measure: urinary incontinence
time frame: 6 Months
description: The rate of urinary incontinence
measure: urination function(IPSS scoring)
time frame: 6 Months
description: evaluation of urination function by IPSS scoring
measure: sexual function (IIEF-5 scoring)
time frame: 6 Months
description: evaluation of sexual function by IIEF-5 scoring
measure: urinary catheter retention time
time frame: 6 Months
description: Record of urinary catheter retention time
arm group label: Steep Pulse Device
arm group type: Experimental
description: Applying the steep pulse to treat the patients with Prostate cancer
intervention type: Device
intervention name: Steep Pulse Device
description: Applying the steep pulse to treat the patients with Prostate cancer
arm group label: Steep Pulse Device
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Second Military Medical University
investigator full name: yinghao Sun
investigator title: director, head of uroglogy department, clinical professor
mesh term: Prostatic Neoplasms