<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/NCT03239652</url>
  </required_header>
  <id_info>
    <org_study_id>A-BR-105-055</org_study_id>
    <nct_id>NCT03239652</nct_id>
  </id_info>
  <brief_title>Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia</brief_title>
  <official_title>Safety and Efficacy of Prostatic Artery Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Industrial Technology Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cheng Kung University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Research Program for Biopharmaceuticals, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cheng-Kung University 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>
      In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy&#xD;
      and safety of microspheres (T-ACE Beads).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      T-ACE Beads can be used for prostatic arterial embolization safely and efficiently.&#xD;
      Furthermore, investigator's microspheres has advantageous characteristics in&#xD;
      biodegradability, drug delivery capability, and cost-effectiveness. After the clinical trial,&#xD;
      we anticipate introducing a new microsphere for Lower Urinary Tract Symptom/Benign prostatic&#xD;
      hyperplasia patients, which is beneficial to the participants in precise medicine as well as&#xD;
      in the pharmaceutical and medical device industry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</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>Patients Survival (Safety)</measure>
    <time_frame>An average of 12 weeks.</time_frame>
    <description>Survival rate was evaluated since treatment day until the date of death or final observation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change on Patient's Symptoms</measure>
    <time_frame>Before treatment, one and three months after treatment</time_frame>
    <description>Change on patients' International Prostate Symptom Score (IPSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on Prostate Volume</measure>
    <time_frame>Before treatment, one and three months after treatment.</time_frame>
    <description>Prostate volume measured using MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum Prostate Specific Antigen (PSA) concentration</measure>
    <time_frame>Before treatment, one and three months after treatment.</time_frame>
    <description>Measurement of Prostate Specific Antigen in patients undergoing this treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Lower Urinary Tract Symptom</condition>
  <condition>Benign Prostatic Hyperplasia (BPH)</condition>
  <arm_group>
    <arm_group_label>Taiwan ACE Beads microspheres</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The maximum use of dosage will not exceed 100 milligrams. The embolization procedure usually lasts less than an hour.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Taiwan ACE Beads</intervention_name>
    <description>Similar with conventional Transcatheter Arterial chemo-embolization, radiologist use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.</description>
    <arm_group_label>Taiwan ACE Beads microspheres</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A. Men ≥ 50 years of age. Healthy patients or volunteers without diagnosis of Lower urinary&#xD;
        tract symptoms (LUTS) / Benign prostatic hyperplasia (BPH) will not be included.&#xD;
&#xD;
        B. Patients diagnosed of LUTS / BPH，International Prostate Symptom Score &gt; 12 with mild to&#xD;
        severe symptom of LUTS.&#xD;
&#xD;
        C. Prostate volume &gt; 50 mL.&#xD;
&#xD;
        D. Urinary flow rate &lt;15 mL / sec.&#xD;
&#xD;
        E. Ineffectiveness after 6 months of previous medical treatment, or the side effects are&#xD;
        too difficult to tolerate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        If patients meet any of the following criteria they may not be entered into the study:&#xD;
&#xD;
        A. Major pelvic disease, or other malignancies.&#xD;
&#xD;
        B. Prostate specific antigen of serum &gt; 10 ng/mL, malignant tumor not yet rule out&#xD;
        (prostate specific antigen PSA&gt;10 ng/mL).&#xD;
&#xD;
        C. Had Prostate surgery.&#xD;
&#xD;
        D. Chronic bacterial prostatitis.&#xD;
&#xD;
        E. Renal dysfunction or bladder diverticulum stones caused by prostate disease obstruction.&#xD;
&#xD;
        F. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical&#xD;
        trials under physicians' consideration.&#xD;
&#xD;
        G. White Blood Cell&lt; 2000 or Severe thrombocytopenia（Platelet count &lt;50,000/μL)，or blood&#xD;
        coagulation abnormalities uncorrectable .&#xD;
&#xD;
        H. Unable to follow-up by MRI 3 times.&#xD;
&#xD;
        I. Unable to follow-up by ultrasound or CT scan.&#xD;
&#xD;
        J. Unwilling to sign a written informed consent form.&#xD;
&#xD;
        K. Allergic to Iodine or other injections.&#xD;
&#xD;
        L. Acute bacterial prostatitis.&#xD;
&#xD;
        M. Patients with active urinary tract infections or recurrent urinary tract infections&#xD;
        (&gt;2/years), prostatitis, or interstitial cystitis.&#xD;
&#xD;
        N. Cases of biopsy proven prostate, bladder, or urethral cancer.&#xD;
&#xD;
        O. Patients with glomerular filtration rates less than 40 who are not already on dialysis.&#xD;
&#xD;
        P. Patients with bilateral internal iliac arterial occlusion.&#xD;
&#xD;
        Q. Patients with causes of bladder obstruction not due to BPH (eg urethral stricture,&#xD;
        bladder neck contraction, etc).&#xD;
&#xD;
        R. Patients with neurogenic or bladder atonia.&#xD;
&#xD;
        S. Patients where embolization is not possible distal to collateral vessels feeding&#xD;
        non-prostatic tissue.&#xD;
&#xD;
        T. Patients with major neurologic illnesses which could have symptoms that may be similar&#xD;
        to or confused for BPH (eg multiple sclerosis, Shy-Drager syndrome, spinal cord injury,&#xD;
        etc.).&#xD;
&#xD;
        U. Patients with urethral stents.&#xD;
&#xD;
        V. Other than hemorrhoidectomy or pelvic irradiation, patients who have undergone prior&#xD;
        rectal surgery.&#xD;
&#xD;
        W. Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase&#xD;
        inhibitors in the month prior to prostatic artery embolization.&#xD;
&#xD;
        X. Allergic to pharmaceutical excipients related to Microspheres.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuh-Shyan Tsai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Urology, National Cheng Kung University Hospital, College of medicine, National Cheng Kung University, Tainan 70403, Taiwan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xi-Zhang Lin, MD</last_name>
    <phone>886-6-2353535</phone>
    <phone_ext>6202/3624</phone_ext>
    <email>linxz@mail.ncku.edu.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hui-Yu Hung, Bachelor</last_name>
    <phone>886-6-2353535</phone>
    <phone_ext>6202/3624</phone_ext>
    <email>z9908033@email.ncku.edu.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xi-Zhang Lin, MD</last_name>
      <phone>886-6-2353535</phone>
      <phone_ext>3624</phone_ext>
      <email>linxz@mail.ncku.edu.tw</email>
    </contact>
    <contact_backup>
      <last_name>Hui-Yu Hung, Bachelor</last_name>
      <phone>886-6-2353535</phone>
      <phone_ext>3624</phone_ext>
      <email>z9908033@email.ncku.edu.tw</email>
    </contact_backup>
    <investigator>
      <last_name>Yuh-Shyan Tsai, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Liu YS, Lin XZ, Tsai HM, Tsai HW, Chen GC, Chen SF, Kang JW, Chou CM, Chen CY. Development of biodegradable radiopaque microsphere for arterial embolization-a pig study. World J Radiol. 2015 Aug 28;7(8):212-9. doi: 10.4329/wjr.v7.i8.212.</citation>
    <PMID>26339465</PMID>
  </results_reference>
  <results_reference>
    <citation>Noor A, Fischman AM. Prostate Artery Embolization as a New Treatment for Benign Prostate Hyperplasia: Contemporary Status in 2016. Curr Urol Rep. 2016 Jul;17(7):51. doi: 10.1007/s11934-016-0608-0.</citation>
    <PMID>27146488</PMID>
  </results_reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>October 15, 2019</last_update_submitted>
  <last_update_submitted_qc>October 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Microsphere</keyword>
  <keyword>Transcatheter Arterial chemo-embolization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
    <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03239652
org study id: A-BR-105-055
nct id: NCT03239652
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy
      and safety of microspheres (T-ACE Beads).
T-ACE Beads can be used for prostatic arterial embolization safely and efficiently.
      Furthermore, investigator's microspheres has advantageous characteristics in
      biodegradability, drug delivery capability, and cost-effectiveness. After the clinical trial,
      we anticipate introducing a new microsphere for Lower Urinary Tract Symptom/Benign prostatic
      hyperplasia patients, which is beneficial to the participants in precise medicine as well as
      in the pharmaceutical and medical device industry.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patients Survival (Safety)
time frame: An average of 12 weeks.
description: Survival rate was evaluated since treatment day until the date of death or final observation.
measure: Change on Patient's Symptoms
time frame: Before treatment, one and three months after treatment
description: Change on patients' International Prostate Symptom Score (IPSS)
measure: Change on Prostate Volume
time frame: Before treatment, one and three months after treatment.
description: Prostate volume measured using MRI
measure: Change in serum Prostate Specific Antigen (PSA) concentration
time frame: Before treatment, one and three months after treatment.
description: Measurement of Prostate Specific Antigen in patients undergoing this treatment.
arm group label: Taiwan ACE Beads microspheres
arm group type: Experimental
description: The maximum use of dosage will not exceed 100 milligrams. The embolization procedure usually lasts less than an hour.
intervention type: Device
intervention name: Taiwan ACE Beads
description: Similar with conventional Transcatheter Arterial chemo-embolization, radiologist use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.
arm group label: Taiwan ACE Beads microspheres
criteria: 
gender: Male
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Yuh-Shyan Tsai, MD
role: Principal Investigator
affiliation: Department of Urology, National Cheng Kung University Hospital, College of medicine, National Cheng Kung University, Tainan 70403, Taiwan
last name: Xi-Zhang Lin, MD
phone: 886-6-2353535
phone ext: 6202/3624
email: linxz@mail.ncku.edu.tw
last name: Hui-Yu Hung, Bachelor
phone: 886-6-2353535
phone ext: 6202/3624
email: z9908033@email.ncku.edu.tw
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Taiwan
citation: Liu YS, Lin XZ, Tsai HM, Tsai HW, Chen GC, Chen SF, Kang JW, Chou CM, Chen CY. Development of biodegradable radiopaque microsphere for arterial embolization-a pig study. World J Radiol. 2015 Aug 28;7(8):212-9. doi: 10.4329/wjr.v7.i8.212.
PMID: 26339465
citation: Noor A, Fischman AM. Prostate Artery Embolization as a New Treatment for Benign Prostate Hyperplasia: Contemporary Status in 2016. Curr Urol Rep. 2016 Jul;17(7):51. doi: 10.1007/s11934-016-0608-0.
PMID: 27146488
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Lower Urinary Tract Symptoms
sharing ipd: No