<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/NCT03009123</url>
  </required_header>
  <id_info>
    <org_study_id>KTGH-ASIAU-obs-erectile</org_study_id>
    <nct_id>NCT03009123</nct_id>
  </id_info>
  <brief_title>Will Erectile Dysfunction Increase the Risk of Prostate Cancer</brief_title>
  <acronym>EDtoPC</acronym>
  <official_title>Erectile Dysfunction and the Future Risk of Prostate Cancer: a Population-based Longitudinal Follow-up Study With Concurrent Double Comparison Cohorts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kuang Tien General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Asia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Central University, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kuang Tien General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The rationale for investigating the hypothesis that there is an association between erectile&#xD;
      dysfunction (ED) and the subsequent development of prostate cancer is based on three&#xD;
      assumptions: 1) baseline ED is common in most if not all of the cross-sectional studies in&#xD;
      men with prostate cancer; 2) the development of ED and prostate cancer may have certain&#xD;
      shared common risk factors; and 3) the use of testosterone for the treatment of ED has been&#xD;
      suspected to be associated with prostate cancer development. Controversy exists over whether&#xD;
      men with ED have an increased risk of subsequent prostate cancer. Few studies have evaluated&#xD;
      the risk of developing prostate cancer for men with ED. The investigators, therefore,&#xD;
      conducted a population-based longitudinal study with eight years' follow-up to examine this&#xD;
      association and to evaluate the magnitude of the risk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">May 6, 2017</completion_date>
  <primary_completion_date type="Actual">March 15, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incident prostate cancer</measure>
    <time_frame>through study completion, up to 7 years</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">21558</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Erectile dysfunction group</arm_group_label>
    <description>Group contains men with physician-diagnosed erectile dysfunction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General population men without ED</arm_group_label>
    <description>Men 50 years and older having no ED and pre-existing prostate cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Symptomatic BPH group without ED</arm_group_label>
    <description>Men 50 years old older with symptomatic prostatic hypertrophy but with no ED nor pre-existing prostate cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Erectile dysfunction</intervention_name>
    <description>Patients with ED are considered belonging to the exposure group.</description>
    <arm_group_label>Erectile dysfunction group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study cohort was constructed from the Taiwan National Health Insurance Research&#xD;
        Dataset. From among men with no pre-existing prostate cancer, we formed an ED group of men&#xD;
        ≥50 years of age and a non-ED general population comparison group of men matched 1:4 by age&#xD;
        and index date of the ED group and a concurrent second comparison group of men older than&#xD;
        50 with benign prostatic hypertrophy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men 50 years and older with no pre-existing prostate cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 50 years old&#xD;
&#xD;
          -  pre-existing prostate cancer&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victor C Kok, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Disease Informatics Research Unit, Asia University Taiwan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kuang Tien General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>43303</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Sairam K, Kulinskaya E, Boustead GB, Hanbury DC, McNicholas TA. Prevalence of undiagnosed prostate cancer in men with erectile dysfunction. BJU Int. 2002 Feb;89(3):261-3. doi: 10.1046/j.1464-4096.2001.01271.x.</citation>
    <PMID>11856107</PMID>
  </reference>
  <reference>
    <citation>Saitz TR, Serefoglu EC, Trost LW, Thomas R, Hellstrom WJ. The pre-treatment prevalence and types of sexual dysfunction among patients diagnosed with prostate cancer. Andrology. 2013 Nov;1(6):859-63. doi: 10.1111/j.2047-2927.2013.00137.x. Epub 2013 Oct 11.</citation>
    <PMID>24127273</PMID>
  </reference>
  <reference>
    <citation>Resnick MJ, Barocas DA, Morgans AK, Phillips SE, Chen VW, Cooperberg MR, Goodman M, Greenfield S, Hamilton AS, Hoffman KE, Kaplan SH, Paddock LE, Stroup AM, Wu XC, Koyama T, Penson DF. Contemporary prevalence of pretreatment urinary, sexual, hormonal, and bowel dysfunction: Defining the population at risk for harms of prostate cancer treatment. Cancer. 2014 Apr 15;120(8):1263-71. doi: 10.1002/cncr.28563. Epub 2014 Feb 7.</citation>
    <PMID>24510400</PMID>
  </reference>
  <reference>
    <citation>Chou PS, Chou WP, Chen MC, Lai CL, Wen YC, Yeh KC, Chang WP, Chou YH. Newly diagnosed erectile dysfunction and risk of depression: a population-based 5-year follow-up study in Taiwan. J Sex Med. 2015 Mar;12(3):804-12. doi: 10.1111/jsm.12792. Epub 2014 Dec 5.</citation>
    <PMID>25475605</PMID>
  </reference>
  <reference>
    <citation>Lee PH, Kok VC, Chou PL, Ku MC, Chen YC, Horng JT. Risk and clinical predictors of osteoporotic fracture in East Asian patients with chronic obstructive pulmonary disease: a population-based cohort study. PeerJ. 2016 Oct 27;4:e2634. doi: 10.7717/peerj.2634. eCollection 2016.</citation>
    <PMID>27812429</PMID>
  </reference>
  <reference>
    <citation>Kok VC, Horng JT, Hung GD, Xu JL, Hung TW, Chen YC, Chen CL. Risk of Autoimmune Disease in Adults with Chronic Insomnia Requiring Sleep-Inducing Pills: A Population-Based Longitudinal Study. J Gen Intern Med. 2016 Sep;31(9):1019-26. doi: 10.1007/s11606-016-3717-z. Epub 2016 Apr 29.</citation>
    <PMID>27130621</PMID>
  </reference>
  <reference>
    <citation>Kok VC, Sung FC, Kao CH, Lin CC, Tseng CH. Cancer risk in East Asian patients associated with acquired haemolytic anaemia: a nationwide population-based cohort study. BMC Cancer. 2016 Feb 4;16:57. doi: 10.1186/s12885-016-2098-3.</citation>
    <PMID>26846920</PMID>
  </reference>
  <reference>
    <citation>Kok VC, Tsai HJ, Su CF, Lee CK. The Risks for Ovarian, Endometrial, Breast, Colorectal, and Other Cancers in Women With Newly Diagnosed Endometriosis or Adenomyosis: A Population-Based Study. Int J Gynecol Cancer. 2015 Jul;25(6):968-76. doi: 10.1097/IGC.0000000000000454.</citation>
    <PMID>25893280</PMID>
  </reference>
  <reference>
    <citation>Kok VC, Horng JT, Huang HK, Chao TM, Hong YF. Regular inhaled corticosteroids in adult-onset asthma and the risk for future cancer: a population-based cohort study with proper person-time analysis. Ther Clin Risk Manag. 2015 Mar 26;11:489-99. doi: 10.2147/TCRM.S80793. eCollection 2015.</citation>
    <PMID>25848295</PMID>
  </reference>
  <reference>
    <citation>Kok VC, Horng JT, Huang JL, Yeh KW, Gau JJ, Chang CW, Zhuang LZ. Population-based cohort study on the risk of malignancy in East Asian children with juvenile idiopathic arthritis. BMC Cancer. 2014 Aug 29;14:634. doi: 10.1186/1471-2407-14-634.</citation>
    <PMID>25174953</PMID>
  </reference>
  <reference>
    <citation>Kok VC, Horng JT, Chang WS, Hong YF, Chang TH. Allopurinol therapy in gout patients does not associate with beneficial cardiovascular outcomes: a population-based matched-cohort study. PLoS One. 2014 Jun 4;9(6):e99102. doi: 10.1371/journal.pone.0099102. eCollection 2014.</citation>
    <PMID>24897240</PMID>
  </reference>
  <reference>
    <citation>Kok VC, Horng JT, Lin HL, Chen YC, Chen YJ, Cheng KF. Gout and subsequent increased risk of cardiovascular mortality in non-diabetics aged 50 and above: a population-based cohort study in Taiwan. BMC Cardiovasc Disord. 2012 Nov 21;12:108. doi: 10.1186/1471-2261-12-108.</citation>
    <PMID>23170782</PMID>
  </reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>May 8, 2017</last_update_submitted>
  <last_update_submitted_qc>May 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kuang Tien General Hospital</investigator_affiliation>
    <investigator_full_name>Victor C. Kok, MMedSc, MD, PhD, FACP</investigator_full_name>
    <investigator_title>Ass. Professor</investigator_title>
  </responsible_party>
  <keyword>cohort study</keyword>
  <keyword>prostate cancer</keyword>
  <keyword>population-based study</keyword>
  <keyword>benign prostatic hypertrophy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Erectile Dysfunction</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/NCT03009123
org study id: KTGH-ASIAU-obs-erectile
nct id: NCT03009123
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The rationale for investigating the hypothesis that there is an association between erectile
      dysfunction (ED) and the subsequent development of prostate cancer is based on three
      assumptions: 1) baseline ED is common in most if not all of the cross-sectional studies in
      men with prostate cancer; 2) the development of ED and prostate cancer may have certain
      shared common risk factors; and 3) the use of testosterone for the treatment of ED has been
      suspected to be associated with prostate cancer development. Controversy exists over whether
      men with ED have an increased risk of subsequent prostate cancer. Few studies have evaluated
      the risk of developing prostate cancer for men with ED. The investigators, therefore,
      conducted a population-based longitudinal study with eight years' follow-up to examine this
      association and to evaluate the magnitude of the risk.
observational model: Cohort
time perspective: Retrospective
measure: Incident prostate cancer
time frame: through study completion, up to 7 years
arm group label: Erectile dysfunction group
description: Group contains men with physician-diagnosed erectile dysfunction
arm group label: General population men without ED
description: Men 50 years and older having no ED and pre-existing prostate cancer
arm group label: Symptomatic BPH group without ED
description: Men 50 years old older with symptomatic prostatic hypertrophy but with no ED nor pre-existing prostate cancer
intervention type: Other
intervention name: Erectile dysfunction
description: Patients with ED are considered belonging to the exposure group.
arm group label: Erectile dysfunction group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 50 Years
maximum age: 99 Years
healthy volunteers: No
last name: Victor C Kok, MD, PhD
role: Study Director
affiliation: Disease Informatics Research Unit, Asia University Taiwan
facility: 
country: Taiwan
citation: Sairam K, Kulinskaya E, Boustead GB, Hanbury DC, McNicholas TA. Prevalence of undiagnosed prostate cancer in men with erectile dysfunction. BJU Int. 2002 Feb;89(3):261-3. doi: 10.1046/j.1464-4096.2001.01271.x.
PMID: 11856107
citation: Saitz TR, Serefoglu EC, Trost LW, Thomas R, Hellstrom WJ. The pre-treatment prevalence and types of sexual dysfunction among patients diagnosed with prostate cancer. Andrology. 2013 Nov;1(6):859-63. doi: 10.1111/j.2047-2927.2013.00137.x. Epub 2013 Oct 11.
PMID: 24127273
citation: Resnick MJ, Barocas DA, Morgans AK, Phillips SE, Chen VW, Cooperberg MR, Goodman M, Greenfield S, Hamilton AS, Hoffman KE, Kaplan SH, Paddock LE, Stroup AM, Wu XC, Koyama T, Penson DF. Contemporary prevalence of pretreatment urinary, sexual, hormonal, and bowel dysfunction: Defining the population at risk for harms of prostate cancer treatment. Cancer. 2014 Apr 15;120(8):1263-71. doi: 10.1002/cncr.28563. Epub 2014 Feb 7.
PMID: 24510400
citation: Chou PS, Chou WP, Chen MC, Lai CL, Wen YC, Yeh KC, Chang WP, Chou YH. Newly diagnosed erectile dysfunction and risk of depression: a population-based 5-year follow-up study in Taiwan. J Sex Med. 2015 Mar;12(3):804-12. doi: 10.1111/jsm.12792. Epub 2014 Dec 5.
PMID: 25475605
citation: Lee PH, Kok VC, Chou PL, Ku MC, Chen YC, Horng JT. Risk and clinical predictors of osteoporotic fracture in East Asian patients with chronic obstructive pulmonary disease: a population-based cohort study. PeerJ. 2016 Oct 27;4:e2634. doi: 10.7717/peerj.2634. eCollection 2016.
PMID: 27812429
citation: Kok VC, Horng JT, Hung GD, Xu JL, Hung TW, Chen YC, Chen CL. Risk of Autoimmune Disease in Adults with Chronic Insomnia Requiring Sleep-Inducing Pills: A Population-Based Longitudinal Study. J Gen Intern Med. 2016 Sep;31(9):1019-26. doi: 10.1007/s11606-016-3717-z. Epub 2016 Apr 29.
PMID: 27130621
citation: Kok VC, Sung FC, Kao CH, Lin CC, Tseng CH. Cancer risk in East Asian patients associated with acquired haemolytic anaemia: a nationwide population-based cohort study. BMC Cancer. 2016 Feb 4;16:57. doi: 10.1186/s12885-016-2098-3.
PMID: 26846920
citation: Kok VC, Tsai HJ, Su CF, Lee CK. The Risks for Ovarian, Endometrial, Breast, Colorectal, and Other Cancers in Women With Newly Diagnosed Endometriosis or Adenomyosis: A Population-Based Study. Int J Gynecol Cancer. 2015 Jul;25(6):968-76. doi: 10.1097/IGC.0000000000000454.
PMID: 25893280
citation: Kok VC, Horng JT, Huang HK, Chao TM, Hong YF. Regular inhaled corticosteroids in adult-onset asthma and the risk for future cancer: a population-based cohort study with proper person-time analysis. Ther Clin Risk Manag. 2015 Mar 26;11:489-99. doi: 10.2147/TCRM.S80793. eCollection 2015.
PMID: 25848295
citation: Kok VC, Horng JT, Huang JL, Yeh KW, Gau JJ, Chang CW, Zhuang LZ. Population-based cohort study on the risk of malignancy in East Asian children with juvenile idiopathic arthritis. BMC Cancer. 2014 Aug 29;14:634. doi: 10.1186/1471-2407-14-634.
PMID: 25174953
citation: Kok VC, Horng JT, Chang WS, Hong YF, Chang TH. Allopurinol therapy in gout patients does not associate with beneficial cardiovascular outcomes: a population-based matched-cohort study. PLoS One. 2014 Jun 4;9(6):e99102. doi: 10.1371/journal.pone.0099102. eCollection 2014.
PMID: 24897240
citation: Kok VC, Horng JT, Lin HL, Chen YC, Chen YJ, Cheng KF. Gout and subsequent increased risk of cardiovascular mortality in non-diabetics aged 50 and above: a population-based cohort study in Taiwan. BMC Cardiovasc Disord. 2012 Nov 21;12:108. doi: 10.1186/1471-2261-12-108.
PMID: 23170782
responsible party type: Principal Investigator
investigator affiliation: Kuang Tien General Hospital
investigator full name: Victor C. Kok, MMedSc, MD, PhD, FACP
investigator title: Ass. Professor
mesh term: Prostatic Neoplasms
mesh term: Erectile Dysfunction
sharing ipd: No