<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/NCT03802851</url>
  </required_header>
  <id_info>
    <org_study_id>143226</org_study_id>
    <nct_id>NCT03802851</nct_id>
  </id_info>
  <brief_title>HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer</brief_title>
  <acronym>HOLEP-RTPC</acronym>
  <official_title>HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</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>
      To determine if holmium laser enucleation of the prostate (HoLEP) for the treatment of lower&#xD;
      urinary tract symptoms (LUTS) and/or urinary retention alters the treatment course for&#xD;
      patients concurrently diagnosed with prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a prospective trial to investigate pre-radiation holmium laser&#xD;
      enucleation (HoLEP) in men with bothersome lower urinary tract symptoms (LUTS) and prostate&#xD;
      cancer who have elected for radiation therapy as the primary treatment modality for their&#xD;
      prostate cancer. The investigators hypothesize that pre-radiation HoLEP may decrease their&#xD;
      overall LUTS and may decrease their need for subsequent radiation therapy. The goal with this&#xD;
      study is to better understand the overlap between prostate cancer and LUTS, as well as&#xD;
      determine if primary surgical treatment for the LUTS with HoLEP can also serve as a possible&#xD;
      treatment modality for concurrent prostate cancer. This information may provide further&#xD;
      information to inform future standard of care practices for patients with prostate cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 19, 2019</start_date>
  <completion_date type="Anticipated">January 2035</completion_date>
  <primary_completion_date type="Anticipated">January 2030</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>
    <intervention_model_description>This is a small scale study with initial enrollment of 20 patients in the treatment arm of the study and an additional 10 patients enrolled in the control arm of the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Quality of Life - One Year Post Operatively</measure>
    <time_frame>Quality of life will be assessed one year post-operatively</time_frame>
    <description>The primary object is to determine if holmium laser enucleation of the prostate (HoLEP) improves the quality of life in patients with concurrent prostate cancer who may undergo radiation therapy as well. Quality of life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC) 26. This instrument evaluates patient function and bother after prostate cancer treatment using 26 items and scored on a 0-100 scale, with higher scores indicating a better health related quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in Quality of Life - Five Years Post Operatively</measure>
    <time_frame>Quality of life will be assessed five years post-operatively</time_frame>
    <description>The primary object is to determine if holmium laser enucleation of the prostate (HoLEP) improves the quality of life in patients with concurrent prostate cancer who may undergo radiation therapy as well. Quality of life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC) 26. This instrument evaluates patient function and bother after prostate cancer treatment using 26 items and scored on a 0-100 scale, with higher scores indicating a better health related quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prostate Cancer Treatment Course - One Year Post Operatively</measure>
    <time_frame>Prostate Cancer Treatment Course will assessed one year post-operatively</time_frame>
    <description>The secondary objective is to determine if holmium laser enucleation of the prostate (HoLEP) alters the prostate cancer treatment course in patients. This will assessed by comparing the time from enrollment to the time of initiation of radiation therapy in patients in both arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate Cancer Treatment Course - Five Years Post Operatively</measure>
    <time_frame>Prostate Cancer Treatment Course will assessed five years post-operatively</time_frame>
    <description>The secondary objective is to determine if holmium laser enucleation of the prostate (HoLEP) alters the prostate cancer treatment course in patients. This will assessed by comparing the time from enrollment to the time of initiation of radiation therapy in patients in both arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>Holmium Laser Enucleation of Prostate (HoLEP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS). Patients will undergo HoLEP one time and will return for standard of care follow up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this arm will undergo no additional interventions and will not undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms and instead follow standard of care treatment and follow up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Holmium Laser Enucleation of Prostate (HoLEP)</intervention_name>
    <description>Holmium laser enucleation of the prostate (HoLEP) is a surgical treatment use for men with bothersome lower urinary tract symptoms (LUTS) to improve their LUTS. During the procedure a thin telescope-like instrument is inserted into the urethra. The high-powered laser is then inserted through this instrument and used to carefully remove the excess prostate tissue that is causing obstruction of the urethra and contributing to the patient's lower urinary tract symptoms.</description>
    <arm_group_label>Holmium Laser Enucleation of Prostate (HoLEP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be 18 years of age or older&#xD;
&#xD;
          -  Patients must have bothersome lower urinary tract symptoms (LUTS), defined by American&#xD;
             Urological Association Symptom Score (AUA SS) of greater than or equal to 15 and/or as&#xD;
             defined by a post-void residual of greater than or equal to 350mL and/or as defined by&#xD;
             catheter dependence&#xD;
&#xD;
          -  Patients must be diagnosed with prostate cancer by pathological tissue analysis&#xD;
&#xD;
          -  Patients must have elected for radiation with androgen deprivation therapy as the&#xD;
             primary treatment modality for their prostate cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are under 18 years of age are not eligible&#xD;
&#xD;
          -  Patients who have a diagnosis of bladder cancer are not eligible.&#xD;
&#xD;
          -  Patients with prior treatment for prostate cancer are not eligible.&#xD;
&#xD;
          -  Patients with any type of prior prostate surgery (minimally invasive, endoscopic, or&#xD;
             otherwise) including prior transurethral resection of the prostate (but excluding&#xD;
             prior prostate biopsy) are ineligible.&#xD;
&#xD;
          -  Patients with known metastatic prostate cancer are ineligible&#xD;
&#xD;
          -  Patients who are enrolled in other surgical or international trials at the time of&#xD;
             this study are not eligible&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jane Ledesma, BS</last_name>
    <phone>(913) 588-8721</phone>
    <email>jledesma2@kumc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Kansas Health System</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>November 15, 2022</last_update_submitted>
  <last_update_submitted_qc>November 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</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>Prostatic Neoplasms</mesh_term>
    <mesh_term>Lower Urinary Tract Symptoms</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/NCT03802851
org study id: 143226
nct id: NCT03802851
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine if holmium laser enucleation of the prostate (HoLEP) for the treatment of lower
      urinary tract symptoms (LUTS) and/or urinary retention alters the treatment course for
      patients concurrently diagnosed with prostate cancer.
The investigators propose a prospective trial to investigate pre-radiation holmium laser
      enucleation (HoLEP) in men with bothersome lower urinary tract symptoms (LUTS) and prostate
      cancer who have elected for radiation therapy as the primary treatment modality for their
      prostate cancer. The investigators hypothesize that pre-radiation HoLEP may decrease their
      overall LUTS and may decrease their need for subsequent radiation therapy. The goal with this
      study is to better understand the overlap between prostate cancer and LUTS, as well as
      determine if primary surgical treatment for the LUTS with HoLEP can also serve as a possible
      treatment modality for concurrent prostate cancer. This information may provide further
      information to inform future standard of care practices for patients with prostate cancer.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This is a small scale study with initial enrollment of 20 patients in the treatment arm of the study and an additional 10 patients enrolled in the control arm of the study.
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in Quality of Life - One Year Post Operatively
time frame: Quality of life will be assessed one year post-operatively
description: The primary object is to determine if holmium laser enucleation of the prostate (HoLEP) improves the quality of life in patients with concurrent prostate cancer who may undergo radiation therapy as well. Quality of life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC) 26. This instrument evaluates patient function and bother after prostate cancer treatment using 26 items and scored on a 0-100 scale, with higher scores indicating a better health related quality of life.
measure: Improvement in Quality of Life - Five Years Post Operatively
time frame: Quality of life will be assessed five years post-operatively
description: The primary object is to determine if holmium laser enucleation of the prostate (HoLEP) improves the quality of life in patients with concurrent prostate cancer who may undergo radiation therapy as well. Quality of life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC) 26. This instrument evaluates patient function and bother after prostate cancer treatment using 26 items and scored on a 0-100 scale, with higher scores indicating a better health related quality of life.
measure: Prostate Cancer Treatment Course - One Year Post Operatively
time frame: Prostate Cancer Treatment Course will assessed one year post-operatively
description: The secondary objective is to determine if holmium laser enucleation of the prostate (HoLEP) alters the prostate cancer treatment course in patients. This will assessed by comparing the time from enrollment to the time of initiation of radiation therapy in patients in both arms.
measure: Prostate Cancer Treatment Course - Five Years Post Operatively
time frame: Prostate Cancer Treatment Course will assessed five years post-operatively
description: The secondary objective is to determine if holmium laser enucleation of the prostate (HoLEP) alters the prostate cancer treatment course in patients. This will assessed by comparing the time from enrollment to the time of initiation of radiation therapy in patients in both arms.
arm group label: Holmium Laser Enucleation of Prostate (HoLEP)
arm group type: Experimental
description: Patients in this arm will undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS). Patients will undergo HoLEP one time and will return for standard of care follow up.
arm group label: Control Arm
arm group type: No Intervention
description: Patients in this arm will undergo no additional interventions and will not undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms and instead follow standard of care treatment and follow up.
intervention type: Procedure
intervention name: Holmium Laser Enucleation of Prostate (HoLEP)
description: Holmium laser enucleation of the prostate (HoLEP) is a surgical treatment use for men with bothersome lower urinary tract symptoms (LUTS) to improve their LUTS. During the procedure a thin telescope-like instrument is inserted into the urethra. The high-powered laser is then inserted through this instrument and used to carefully remove the excess prostate tissue that is causing obstruction of the urethra and contributing to the patient's lower urinary tract symptoms.
arm group label: Holmium Laser Enucleation of Prostate (HoLEP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jane Ledesma, BS
phone: (913) 588-8721
email: jledesma2@kumc.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Lower Urinary Tract Symptoms