<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/NCT03817216</url>
  </required_header>
  <id_info>
    <org_study_id>CASE10818</org_study_id>
    <nct_id>NCT03817216</nct_id>
  </id_info>
  <brief_title>Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer</brief_title>
  <official_title>Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer: Prospective Analysis of Outcomes in Patients With Obstructive Urinary Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the use of the Prostatic Urethral Lift (PUL), Urolift®,&#xD;
      in prostate cancer (Pca) participants seeking or undergoing radiotherapy for relief of&#xD;
      urinary obstructive symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostatic Urethral Lift (PUL)/ UroLift® is an FDA-approved device for the treatment of&#xD;
      obstructive symptoms due to benign prostatic hyperplasia (BPH) (also called prostate gland&#xD;
      enlargement). This study seeks to evaluate UroLift's efficacy in a unique cohort of&#xD;
      participants with obstructive symptoms who are candidates for radiotherapy or those who&#xD;
      developed obstructive symptoms after radiotherapy. The primary objective of this study is to&#xD;
      achieve urinary obstructive symptom relief in prostate cancer participants undergoing&#xD;
      radiotherapy treatment with placement of PUL. This will be quantified using primary&#xD;
      effectiveness endpoints:&#xD;
&#xD;
        -  For PUL placement post-EBRT and post-BT: ≥ 30% or ≥ 4 point International Prostate&#xD;
           Symptom Score (IPSS) reduction 3 months after PUL.&#xD;
&#xD;
        -  For PUL placement pre-BT: ≥ 30% or ≥ 4 point IPSS reduction 3 months after Brachytherapy&#xD;
           (BT) from pre-PUL baseline.&#xD;
&#xD;
      The team will also assess participant outcomes with regard to International Prostate Symptom&#xD;
      Score (IPSS), peak urine flow (Qmax),post-void residual (PVR), quality of life (QOL) scores,&#xD;
      Benign Prostatic Hyperplasia Impact Index (BPHII) scores, Men's Sexual Health Questionnaire&#xD;
      (MSHQ) scores, and urinary incontinence at 6 and 12 months of PUL placement post-External&#xD;
      Beam Radiotherapy (EBRT), post-BT, and pre-BT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    re-written and submitted as a new study&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2019</start_date>
  <completion_date type="Anticipated">March 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in International Prostate Symptom Score (IPSS) - Arms: PUL placement post-EBRT and PUL placement post-BT</measure>
    <time_frame>3 months post-PUL placement</time_frame>
    <description>IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia.&#xD;
A mean change in International Prostate Symptom Score (IPSS) will be considered effective if the following condition is met:&#xD;
≥ 30% or ≥ 4 point IPSS reduction 3 months after PUL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change in International Prostate Symptom Score (IPSS) - Arm: PUL placement pre-BT.</measure>
    <time_frame>3 months post-BT</time_frame>
    <description>IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia.&#xD;
A mean change in International Prostate Symptom Score (IPSS) will be considered effective if the following condition is met:&#xD;
30% or ≥ 4 point IPSS reduction 3 months after BT from pre-PUL baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in International Prostate Symptom Score (IPSS)</measure>
    <time_frame>6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT &amp; Post-EBRT arms)</time_frame>
    <description>IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia.&#xD;
Mean change in IPSS score will be reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in peak urinary flow rate (Qmax)</measure>
    <time_frame>6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT &amp; Post-EBRT arms)</time_frame>
    <description>Qmax is the quantity of urine measured over a specified period of time. A significant outcome would be a greater than 50% change in Qmax.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life scores from last question on IPSS questionnaire</measure>
    <time_frame>6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT &amp; Post-EBRT arms)</time_frame>
    <description>QOL score (last question in the IPSS questionnaire): If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?&#xD;
With answer options on a 0-6 scale with 0 being delighted and 6 being terrible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in Benign Prostatic Hyperplasia Impact Index (BPHII) scores</measure>
    <time_frame>6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT &amp; Post-EBRT arms)</time_frame>
    <description>The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire with four questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities.&#xD;
Mean change in BPHII score will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in the MSHQ total score</measure>
    <time_frame>6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT &amp; Post-EBRT arms)</time_frame>
    <description>Men's Sexual Health Questionnaire (MSHQ) is a 18-item questionnaire focused on assessing three core function domains (erection, ejaculation and satisfaction).&#xD;
Mean change in the MSHQ ejaculation total score will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary incontinence measured by number of pads used</measure>
    <time_frame>6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT &amp; Post-EBRT arms)</time_frame>
    <description>Assessment of urinary incontinence associated with the procedure measured by change number of pads used per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary incontinence measured by quality of stress or urge</measure>
    <time_frame>6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT &amp; Post-EBRT arms)</time_frame>
    <description>Assessment of urinary incontinence associated with the procedure as measured by quality: stress or urge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary incontinence measured by cough stress test</measure>
    <time_frame>6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT &amp; Post-EBRT arms)</time_frame>
    <description>Assessment of urinary incontinence associated with the procedure as measured by cough test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary incontinence measured by time to resolve</measure>
    <time_frame>6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT &amp; Post-EBRT arms)</time_frame>
    <description>Assessment of urinary incontinence associated with the procedure as measured by time to resolve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in post-void residual (PVR)</measure>
    <time_frame>3, 6, and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT &amp; Post-EBRT arms</time_frame>
    <description>Assessment of PVR, the amount of urine left in the bladder after urination.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Benign Prostatic Hyperplasia (BPH)</condition>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Prostatic Urethral Lift (PUL) post-EBRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prostatic Urethral Lift (PUL) following External Beam Radiotherapy (EBRT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prostatic Urethral Lift (PUL) pre-BT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prostatic Urethral Lift (PUL) preceding Brachytherapy (BT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prostatic Urethral Lift (PUL) post-BT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prostatic Urethral Lift (PUL) following Brachytherapy (BT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prostatic Urethral Lift (PUL)</intervention_name>
    <description>PUL/ UroLift® is an FDA-approved device for the treatment of obstructive symptoms due to benign prostatic hyperplasia (BPH). This study evaluates UroLift's efficacy participants with obstructive symptoms who are candidates for radiotherapy or those who developed obstructive symptoms after radiotherapy.</description>
    <arm_group_label>Prostatic Urethral Lift (PUL) post-BT</arm_group_label>
    <arm_group_label>Prostatic Urethral Lift (PUL) post-EBRT</arm_group_label>
    <arm_group_label>Prostatic Urethral Lift (PUL) pre-BT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  International Prostate Symptom Score ≥ 12.&#xD;
&#xD;
          -  Peak flow rate ≤ 12 ml/sec with at least 125 ml voided urine.&#xD;
&#xD;
          -  Prostate volume ≤ 80 cc as measured either by trans-rectal ultrasound (US) or Magnetic&#xD;
             Resonance Imaging (MRI).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obstructive median lobe of the prostate.&#xD;
&#xD;
          -  Active urinary tract infection.&#xD;
&#xD;
          -  Neurogenic non-obstructive voiding dysfunction.&#xD;
&#xD;
          -  Obstructive symptoms secondary to prostate cancer (via cystoscopy).&#xD;
&#xD;
          -  Patients with prior Transurethral resection of the prostate (TURP).&#xD;
&#xD;
          -  Patients with prior history of urethral stricture.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>51 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irina Jaeger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>March 10, 2020</last_update_submitted>
  <last_update_submitted_qc>March 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostatic Urethral Lift (PUL)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</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/NCT03817216
org study id: CASE10818
nct id: NCT03817216
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to test the use of the Prostatic Urethral Lift (PUL), Urolift®,
      in prostate cancer (Pca) participants seeking or undergoing radiotherapy for relief of
      urinary obstructive symptoms.
Prostatic Urethral Lift (PUL)/ UroLift® is an FDA-approved device for the treatment of
      obstructive symptoms due to benign prostatic hyperplasia (BPH) (also called prostate gland
      enlargement). This study seeks to evaluate UroLift's efficacy in a unique cohort of
      participants with obstructive symptoms who are candidates for radiotherapy or those who
      developed obstructive symptoms after radiotherapy. The primary objective of this study is to
      achieve urinary obstructive symptom relief in prostate cancer participants undergoing
      radiotherapy treatment with placement of PUL. This will be quantified using primary
      effectiveness endpoints:

        -  For PUL placement post-EBRT and post-BT: ≥ 30% or ≥ 4 point International Prostate
           Symptom Score (IPSS) reduction 3 months after PUL.

        -  For PUL placement pre-BT: ≥ 30% or ≥ 4 point IPSS reduction 3 months after Brachytherapy
           (BT) from pre-PUL baseline.

      The team will also assess participant outcomes with regard to International Prostate Symptom
      Score (IPSS), peak urine flow (Qmax),post-void residual (PVR), quality of life (QOL) scores,
      Benign Prostatic Hyperplasia Impact Index (BPHII) scores, Men's Sexual Health Questionnaire
      (MSHQ) scores, and urinary incontinence at 6 and 12 months of PUL placement post-External
      Beam Radiotherapy (EBRT), post-BT, and pre-BT.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Mean change in International Prostate Symptom Score (IPSS) - Arms: PUL placement post-EBRT and PUL placement post-BT
time frame: 3 months post-PUL placement
description: IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia.
A mean change in International Prostate Symptom Score (IPSS) will be considered effective if the following condition is met:
≥ 30% or ≥ 4 point IPSS reduction 3 months after PUL.
measure: Mean change in International Prostate Symptom Score (IPSS) - Arm: PUL placement pre-BT.
time frame: 3 months post-BT
description: IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia.
A mean change in International Prostate Symptom Score (IPSS) will be considered effective if the following condition is met:
30% or ≥ 4 point IPSS reduction 3 months after BT from pre-PUL baseline.
measure: Mean change in International Prostate Symptom Score (IPSS)
time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description: IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia.
Mean change in IPSS score will be reported
measure: Mean change in peak urinary flow rate (Qmax)
time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description: Qmax is the quantity of urine measured over a specified period of time. A significant outcome would be a greater than 50% change in Qmax.
measure: Quality of life scores from last question on IPSS questionnaire
time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description: QOL score (last question in the IPSS questionnaire): If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?
With answer options on a 0-6 scale with 0 being delighted and 6 being terrible.
measure: Mean change in Benign Prostatic Hyperplasia Impact Index (BPHII) scores
time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description: The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire with four questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities.
Mean change in BPHII score will be reported.
measure: Mean change in the MSHQ total score
time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description: Men's Sexual Health Questionnaire (MSHQ) is a 18-item questionnaire focused on assessing three core function domains (erection, ejaculation and satisfaction).
Mean change in the MSHQ ejaculation total score will be reported.
measure: Urinary incontinence measured by number of pads used
time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description: Assessment of urinary incontinence associated with the procedure measured by change number of pads used per day.
measure: Urinary incontinence measured by quality of stress or urge
time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description: Assessment of urinary incontinence associated with the procedure as measured by quality: stress or urge.
measure: Urinary incontinence measured by cough stress test
time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description: Assessment of urinary incontinence associated with the procedure as measured by cough test.
measure: Urinary incontinence measured by time to resolve
time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
description: Assessment of urinary incontinence associated with the procedure as measured by time to resolve.
measure: Mean change in post-void residual (PVR)
time frame: 3, 6, and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms
description: Assessment of PVR, the amount of urine left in the bladder after urination.
arm group label: Prostatic Urethral Lift (PUL) post-EBRT
arm group type: Experimental
description: Prostatic Urethral Lift (PUL) following External Beam Radiotherapy (EBRT)
arm group label: Prostatic Urethral Lift (PUL) pre-BT
arm group type: Experimental
description: Prostatic Urethral Lift (PUL) preceding Brachytherapy (BT)
arm group label: Prostatic Urethral Lift (PUL) post-BT
arm group type: Active Comparator
description: Prostatic Urethral Lift (PUL) following Brachytherapy (BT)
intervention type: Device
intervention name: Prostatic Urethral Lift (PUL)
description: PUL/ UroLift® is an FDA-approved device for the treatment of obstructive symptoms due to benign prostatic hyperplasia (BPH). This study evaluates UroLift's efficacy participants with obstructive symptoms who are candidates for radiotherapy or those who developed obstructive symptoms after radiotherapy.
arm group label: Prostatic Urethral Lift (PUL) post-BT
arm group label: Prostatic Urethral Lift (PUL) post-EBRT
arm group label: Prostatic Urethral Lift (PUL) pre-BT
criteria: 
gender: Male
minimum age: 51 Years
maximum age: N/A
healthy volunteers: No
last name: Irina Jaeger, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia