<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/NCT01678313</url>
  </required_header>
  <id_info>
    <org_study_id>TCGHUROL004</org_study_id>
    <nct_id>NCT01678313</nct_id>
  </id_info>
  <brief_title>Cyclooxygenase-2 (COX-2) Inhibitor Reduces Serum Prostatic Specific Antigen (PSA) Levels</brief_title>
  <official_title>COX-2 Inhibitor Reduces Serum PSA Levels Might Predict a Lower Risk of Prostatic Cancer in Men With LUTS/BPH With an Elevated PSA Level</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Buddhist Tzu Chi General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Buddhist Tzu Chi General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the therapeutic effect and safety of celecoxib adding on doxazosin and the&#xD;
      potential predictive value of the absence of prostate cancer in the treatment of patients&#xD;
      with LUTS/BPH and an elevated serum PSA level.&#xD;
&#xD;
      Patients who meet all eligible requirements for entry into the study will be randomized into&#xD;
      one of the two treatment groups for 3 months in 2:1 ratio as shown below:&#xD;
&#xD;
        1. Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)&#xD;
&#xD;
        2. Doxazosin 4mg every day (QD)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Procedure&#xD;
&#xD;
        -  Male patients aged 40 years or older, having LUTS for at least 3 months (IPSS ≥ 8), a&#xD;
           serum PSA level ≥ 4 ng/mL, without a palpable prostatic nodule will be enrolled into&#xD;
           this prospective randomized trial to investigate whether COX-2 inhibitor can decrease&#xD;
           serum PSA level and acts as a biomarker to differentiate between chronic inflammation&#xD;
           and prostate cancer.&#xD;
&#xD;
        -  Eligible subjects will be randomly assigned to the study and control groups at 2:1&#xD;
           ratio. The study group will receive doxazosin 4mg every day (QD) plus celecoxib 200mg QD&#xD;
           for 3 months and the control group will receive doxazosin 4 mg QD for 3 months. Patients&#xD;
           will be investigated for IPSS, total prostatic volume, transition zone index, maximum&#xD;
           flow rate, voided volume, postvoid residual, serum PSA, free PSA and serum C-reactive&#xD;
           protein (CRP) levels at baseline and 3 months after treatment. If the serum PSA levels&#xD;
           remained higher than 4 ng/mL, patients of either group will be advised to receive&#xD;
           prostatic biopsy for histopathological investigation.&#xD;
&#xD;
        -  The prostatic biopsy will be advised at the end of the study in both groups of patients.&#xD;
           Ten prostatic biopsied strips will be sent to pathological department for investigating&#xD;
           the existence of prostatic cancer. The other two strips will be stored in liquid&#xD;
           nitrogen for further investigation of inflammatory biomarkers.&#xD;
&#xD;
      Data Analysis&#xD;
&#xD;
        -  The efficacy evaluation will be performed on intention-to-treat populations (ITT) and&#xD;
           per-protocol populations (PPP) datasets while the safety evaluation will be performed on&#xD;
           ITT datasets. The primary conclusion will be made for the primary endpoint and secondary&#xD;
           endpoint on the ITT population.&#xD;
&#xD;
      Efficacy Endpoint Analysis&#xD;
&#xD;
        -  Net change of each efficacy item will be analyzed by paired t-test between baseline and&#xD;
           post-treatment in the treatment group and controlled group. The net changes of each&#xD;
           efficacy item will be analyzed by ANOVA test to compare between treatment group and&#xD;
           controlled group. The global assessment by the patients will be analyzed by chi-square&#xD;
           test between the treatment and controlled group.&#xD;
&#xD;
        -  All efficacy variables will be reported of respective point estimated and 95% confidence&#xD;
           interval. Comparison tests will be reported of respective p value.&#xD;
&#xD;
      Safety Endpoints&#xD;
&#xD;
        -  Adverse events will be reported by both controlled and treatment groups and by&#xD;
           physiological systems as appropriate. Incidence of adverse events and the categories of&#xD;
           adverse event severity between treatments will be analyzed by Cochran-Mantel-Haenszel&#xD;
           test. The coding system used will be the Coding Symbols for a Thesaurus of Adverse&#xD;
           Reaction Terms (COSTART).&#xD;
&#xD;
      Changes in physical examinations will be displayed for each individual system.&#xD;
&#xD;
        -  All statistical tests used will be two-tailed with α= 0.05.&#xD;
&#xD;
      Expected Results and Conclusion&#xD;
&#xD;
        -  Chronic inflammation has been considered a possible but important factor to induce LUTS&#xD;
           and promote prostatic growth. PSA elevation is a sensitive but not specific sign for&#xD;
           prostatic cancer. In order to reduce the need for prostatic biopsy in patients with an&#xD;
           elevated serum PSA level, the results of this study might provide a simple way for&#xD;
           initial differential diagnosis of chronic inflammation from prostatic cancer. If serum&#xD;
           PSA can be reduced significantly after celecoxib therapy and the positive biopsy rate of&#xD;
           the following prostatic biopsy is lower than the control group, we might use this&#xD;
           treatment for the initial management of high PSA level in men with LUTS/BPH.&#xD;
           Furthermore, if chronic inflammation of the prostate can be reduced, the bothersome of&#xD;
           the LUTS as well as voiding condition might be improved. This result can be another&#xD;
           benefit for men who are suffering from LUTS and worried about surgical intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level</measure>
    <time_frame>Baseline and 3 months after initial treatment</time_frame>
    <description>Efficacy:&#xD;
Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Void Volume (VV)</measure>
    <time_frame>Baseline and 3 months after initial treatment</time_frame>
    <description>Efficacy:&#xD;
Change from Baseline in the Void Volume (VV) from baseline and 3 months Change = Month 3 minus Baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Maximum Flow Rate (Qmax)</measure>
    <time_frame>Baseline and 3 months after initial treatment</time_frame>
    <description>Efficacy:&#xD;
Change from Baseline in the maximum flow rate (Qmax) from baseline and 3 months Change = Month 3 minus Baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires</measure>
    <time_frame>Baseline and 3 months after initial treatment</time_frame>
    <description>Efficacy:&#xD;
Change from Baseline in the IPSS Voiding from baseline and 3 months. The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.&#xD;
The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).&#xD;
Change = Month 3 minus Baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires</measure>
    <time_frame>Baseline and 3 months after initial treatment</time_frame>
    <description>Efficacy:&#xD;
Change from Baseline in the IPSS Storage from baseline and 3 months The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.&#xD;
The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).&#xD;
Change = Month 3 minus Baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires</measure>
    <time_frame>Baseline and 3 months after initial treatment</time_frame>
    <description>Efficacy:&#xD;
Change from Baseline in the International Prostate Symptom Score (IPSS) from baseline and 3 months The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS Voiding), 3 storage questions (IPSS Storage) The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;.&#xD;
Total IPSS score = IPSS voiding + IPSS Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35&#xD;
Change = Month 3 minus Baseline value</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Benign Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Doxazosin 4 mg every day (QD)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)</intervention_name>
    <description>Study group</description>
    <arm_group_label>Study group</arm_group_label>
    <other_name>Doxazosin 4 mg</other_name>
    <other_name>Celecoxib 200 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxazosin 4 mg every day (QD)</intervention_name>
    <description>Control group</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Doxazosin 4 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male adults aged ≥ 40 years with LUTS/BPH, IPSS ≥ 8&#xD;
&#xD;
          -  Free of active urinary tract infection&#xD;
&#xD;
          -  Free of neurogenic voiding dysfunction&#xD;
&#xD;
          -  No history of previous prostate biopsy within 6 months&#xD;
&#xD;
          -  No treatment of BPH by alpha-blocker or 5-alpha-reductase inhibitor within 6 months&#xD;
&#xD;
          -  Patient or his legally acceptable representative has signed the written informed&#xD;
             consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe cardiopulmonary disease and such as congestive heart failure,&#xD;
             arrhythmia, poorly controlled hypertension, not able to receive regular follow-up&#xD;
&#xD;
          -  Patients with acute r chronic urinary retention and urodynamically proven detrusor&#xD;
             underactivity&#xD;
&#xD;
          -  Patients with postvoid residual &gt; 250 mL&#xD;
&#xD;
          -  Patients have laboratory abnormalities at screening including:&#xD;
&#xD;
               1. Aspartate aminotransferase (AST) &gt; 3 x upper limit of normal range&#xD;
&#xD;
               2. Alanine aminotransferase (ALT) &gt; 3 x upper limit of normal range&#xD;
&#xD;
               3. Patients have abnormal serum creatinine level &gt; 2 x upper limit of normal range&#xD;
&#xD;
          -  Patients with any other serious disease or condition considered by the investigator&#xD;
             not suitable for entry into the trial&#xD;
&#xD;
          -  Patients participated investigational drug trial within 1 month before entering this&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hann-Chorng Kuo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Buddhist Tzu Chi General Hospital</name>
      <address>
        <city>Hualien</city>
        <zip>970</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Liu HT, Kuo HC. Urinary nerve growth factor levels are increased in patients with bladder outlet obstruction with overactive bladder symptoms and reduced after successful medical treatment. Urology. 2008 Jul;72(1):104-8; discussion 108. doi: 10.1016/j.urology.2008.01.069. Epub 2008 Apr 8.</citation>
    <PMID>18400272</PMID>
  </reference>
  <reference>
    <citation>St Sauver JL, Sarma AV, Jacobson DJ, McGree ME, Lieber MM, Girman CJ, Nehra A, Jacobsen SJ. Associations between C-reactive protein and benign prostatic hyperplasia/lower urinary tract symptom outcomes in a population-based cohort. Am J Epidemiol. 2009 Jun 1;169(11):1281-90. doi: 10.1093/aje/kwp085. Epub 2009 Apr 24.</citation>
    <PMID>19395697</PMID>
  </reference>
  <reference>
    <citation>Andersson KE. LUTS treatment: future treatment options. Neurourol Urodyn. 2007 Oct;26(6 Suppl):934-47. doi: 10.1002/nau.20500.</citation>
    <PMID>17696154</PMID>
  </reference>
  <reference>
    <citation>Kuo HC. Videourodynamic analysis of pathophysiology of men with both storage and voiding lower urinary tract symptoms. Urology. 2007 Aug;70(2):272-6. doi: 10.1016/j.urology.2007.03.063.</citation>
    <PMID>17826488</PMID>
  </reference>
  <reference>
    <citation>Di Silverio F, Gentile V, De Matteis A, Mariotti G, Giuseppe V, Luigi PA, Sciarra A. Distribution of inflammation, pre-malignant lesions, incidental carcinoma in histologically confirmed benign prostatic hyperplasia: a retrospective analysis. Eur Urol. 2003 Feb;43(2):164-75. doi: 10.1016/s0302-2838(02)00548-1.</citation>
    <PMID>12565775</PMID>
  </reference>
  <reference>
    <citation>Sciarra A, Mariotti G, Salciccia S, Autran Gomez A, Monti S, Toscano V, Di Silverio F. Prostate growth and inflammation. J Steroid Biochem Mol Biol. 2008 Feb;108(3-5):254-60. doi: 10.1016/j.jsbmb.2007.09.013. Epub 2007 Sep 7.</citation>
    <PMID>17935971</PMID>
  </reference>
  <reference>
    <citation>Sciarra A, Di Silverio F, Salciccia S, Autran Gomez AM, Gentilucci A, Gentile V. Inflammation and chronic prostatic diseases: evidence for a link? Eur Urol. 2007 Oct;52(4):964-72. doi: 10.1016/j.eururo.2007.06.038. Epub 2007 Jul 2.</citation>
    <PMID>17618043</PMID>
  </reference>
  <reference>
    <citation>Alcaraz A, Hammerer P, Tubaro A, Schroder FH, Castro R. Is there evidence of a relationship between benign prostatic hyperplasia and prostate cancer? Findings of a literature review. Eur Urol. 2009 Apr;55(4):864-73. doi: 10.1016/j.eururo.2008.11.011. Epub 2008 Nov 21.</citation>
    <PMID>19027219</PMID>
  </reference>
  <reference>
    <citation>Di Silverio F, Bosman C, Salvatori M, Albanesi L, Proietti Pannunzi L, Ciccariello M, Cardi A, Salvatori G, Sciarra A. Combination therapy with rofecoxib and finasteride in the treatment of men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). Eur Urol. 2005 Jan;47(1):72-8; discussion 78-9. doi: 10.1016/j.eururo.2004.08.024.</citation>
    <PMID>15582252</PMID>
  </reference>
  <reference>
    <citation>Ozdemir I, Bozkurt O, Demir O, Aslan G, Esen AA. Combination therapy with doxazosin and tenoxicam for the management of lower urinary tract symptoms. Urology. 2009 Aug;74(2):431-5. doi: 10.1016/j.urology.2009.01.088. Epub 2009 Jun 7.</citation>
    <PMID>19501883</PMID>
  </reference>
  <reference>
    <citation>Jang J, Park EY, Seo SI, Hwang TK, Kim JC. Effects of intravesical instillation of cyclooxygenase-2 inhibitor on the expression of inducible nitric oxide synthase and nerve growth factor in cyclophosphamide-induced overactive bladder. BJU Int. 2006 Aug;98(2):435-9. doi: 10.1111/j.1464-410X.2006.06207.x.</citation>
    <PMID>16879691</PMID>
  </reference>
  <reference>
    <citation>Falahatkar S, Mokhtari G, Pourreza F, Asgari SA, Kamran AN. Celecoxib for treatment of nocturia caused by benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled study. Urology. 2008 Oct;72(4):813-6. doi: 10.1016/j.urology.2008.04.069. Epub 2008 Aug 9.</citation>
    <PMID>18692876</PMID>
  </reference>
  <reference>
    <citation>Djavan B, Waldert M, Zlotta A, Dobronski P, Seitz C, Remzi M, Borkowski A, Schulman C, Marberger M. Safety and morbidity of first and repeat transrectal ultrasound guided prostate needle biopsies: results of a prospective European prostate cancer detection study. J Urol. 2001 Sep;166(3):856-60.</citation>
    <PMID>11490233</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <results_first_submitted>April 8, 2014</results_first_submitted>
  <results_first_submitted_qc>May 28, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 30, 2014</results_first_posted>
  <last_update_submitted>July 2, 2014</last_update_submitted>
  <last_update_submitted_qc>July 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Buddhist Tzu Chi General Hospital</investigator_affiliation>
    <investigator_full_name>Hann-Chorng Kuo</investigator_full_name>
    <investigator_title>Department of Urology</investigator_title>
  </responsible_party>
  <keyword>Benign prostatic hyperplasia (BPH)</keyword>
  <keyword>Lower urinary tract symptoms (LUTS)</keyword>
  <keyword>Prostatic specific antigen (PSA)</keyword>
  <keyword>Cyclooxygenase-2 (COX-2)</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celecoxib</mesh_term>
    <mesh_term>Doxazosin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>140 Patients with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and PSA&gt;4 ng/dL underwent randomization 70 patients in study group 70 patients in control group</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Study Group</title>
          <description>Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Doxazosin 4 mg every day (QD)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Completed the 3-month Therapy</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>PSA &gt;4 ng/dL at 3 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>PSA≦4</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Prostate Biopsy at 3 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not received prostate biopsy</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study Group</title>
          <description>Doxazosin 4 mg daily plus celecoxib 200 mg daily, complete 3 month therapy N=64(91.4%)</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Doxazosin 4 mg alone everyday, complete 3 month therapy N=58(82.9%)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="64"/>
            <count group_id="B2" value="58"/>
            <count group_id="B3" value="122"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.4" spread="9.5"/>
                    <measurement group_id="B2" value="73.8" spread="8.0"/>
                    <measurement group_id="B3" value="72.1" spread="8.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level</title>
        <description>Efficacy:&#xD;
Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value</description>
        <time_frame>Baseline and 3 months after initial treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Doxazosin 4 mg every day (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level</title>
          <description>Efficacy:&#xD;
Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value</description>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" spread="5.42"/>
                    <measurement group_id="O2" value="15.2" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.42" spread="5.41"/>
                    <measurement group_id="O2" value="13.5" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.43" spread="0.01"/>
                    <measurement group_id="O2" value="-1.70" spread="2.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Void Volume (VV)</title>
        <description>Efficacy:&#xD;
Change from Baseline in the Void Volume (VV) from baseline and 3 months Change = Month 3 minus Baseline value</description>
        <time_frame>Baseline and 3 months after initial treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Doxazosin 4 mg every day (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Void Volume (VV)</title>
          <description>Efficacy:&#xD;
Change from Baseline in the Void Volume (VV) from baseline and 3 months Change = Month 3 minus Baseline value</description>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="259" spread="113"/>
                    <measurement group_id="O2" value="175" spread="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="227" spread="80.8"/>
                    <measurement group_id="O2" value="231" spread="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.3" spread="32.1"/>
                    <measurement group_id="O2" value="55.7" spread="27.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Maximum Flow Rate (Qmax)</title>
        <description>Efficacy:&#xD;
Change from Baseline in the maximum flow rate (Qmax) from baseline and 3 months Change = Month 3 minus Baseline value</description>
        <time_frame>Baseline and 3 months after initial treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Doxazosin 4 mg every day (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Maximum Flow Rate (Qmax)</title>
          <description>Efficacy:&#xD;
Change from Baseline in the maximum flow rate (Qmax) from baseline and 3 months Change = Month 3 minus Baseline value</description>
          <units>mL/s</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" spread="4.67"/>
                    <measurement group_id="O2" value="10.0" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" spread="4.19"/>
                    <measurement group_id="O2" value="11.9" spread="6.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.49"/>
                    <measurement group_id="O2" value="1.9" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires</title>
        <description>Efficacy:&#xD;
Change from Baseline in the IPSS Voiding from baseline and 3 months. The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.&#xD;
The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).&#xD;
Change = Month 3 minus Baseline value</description>
        <time_frame>Baseline and 3 months after initial treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Doxazosin 4 mg every day (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires</title>
          <description>Efficacy:&#xD;
Change from Baseline in the IPSS Voiding from baseline and 3 months. The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.&#xD;
The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).&#xD;
Change = Month 3 minus Baseline value</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.55" spread="6.84"/>
                    <measurement group_id="O2" value="5.54" spread="5.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.84" spread="4.57"/>
                    <measurement group_id="O2" value="3.45" spread="4.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.71" spread="2.27"/>
                    <measurement group_id="O2" value="-2.09" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires</title>
        <description>Efficacy:&#xD;
Change from Baseline in the IPSS Storage from baseline and 3 months The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.&#xD;
The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).&#xD;
Change = Month 3 minus Baseline value</description>
        <time_frame>Baseline and 3 months after initial treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Doxazosin 4 mg every day (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires</title>
          <description>Efficacy:&#xD;
Change from Baseline in the IPSS Storage from baseline and 3 months The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.&#xD;
The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).&#xD;
Change = Month 3 minus Baseline value</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.59" spread="3.72"/>
                    <measurement group_id="O2" value="6.06" spread="3.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.09" spread="1.4"/>
                    <measurement group_id="O2" value="4.01" spread="2.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="2.32"/>
                    <measurement group_id="O2" value="-2.05" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires</title>
        <description>Efficacy:&#xD;
Change from Baseline in the International Prostate Symptom Score (IPSS) from baseline and 3 months The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS Voiding), 3 storage questions (IPSS Storage) The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;.&#xD;
Total IPSS score = IPSS voiding + IPSS Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35&#xD;
Change = Month 3 minus Baseline value</description>
        <time_frame>Baseline and 3 months after initial treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Doxazosin 4 mg every day (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires</title>
          <description>Efficacy:&#xD;
Change from Baseline in the International Prostate Symptom Score (IPSS) from baseline and 3 months The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS Voiding), 3 storage questions (IPSS Storage) The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;.&#xD;
Total IPSS score = IPSS voiding + IPSS Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35&#xD;
Change = Month 3 minus Baseline value</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" spread="7.65"/>
                    <measurement group_id="O2" value="12.0" spread="7.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.45" spread="3.18"/>
                    <measurement group_id="O2" value="7.70" spread="5.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.63" spread="4.47"/>
                    <measurement group_id="O2" value="-4.31" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the 3-month clinical follow up</time_frame>
      <desc>No patient suffered from heart attack, stroke, thromboembolic events or peptic ulcer. No adverse event related to the test medications was observed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Study Group</title>
          <description>Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Doxazosin 4 mg every day (QD)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Hann-Chorng Kuo</name_or_title>
      <organization>Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University</organization>
      <phone>886-3-8561825 ext 2113</phone>
      <email>hck@tzuchi.com.tw</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01678313
org study id: TCGHUROL004
nct id: NCT01678313
lead sponsor: 
has dmc: No
To investigate the therapeutic effect and safety of celecoxib adding on doxazosin and the
      potential predictive value of the absence of prostate cancer in the treatment of patients
      with LUTS/BPH and an elevated serum PSA level.

      Patients who meet all eligible requirements for entry into the study will be randomized into
      one of the two treatment groups for 3 months in 2:1 ratio as shown below:

        1. Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)

        2. Doxazosin 4mg every day (QD)
Study Procedure

        -  Male patients aged 40 years or older, having LUTS for at least 3 months (IPSS ≥ 8), a
           serum PSA level ≥ 4 ng/mL, without a palpable prostatic nodule will be enrolled into
           this prospective randomized trial to investigate whether COX-2 inhibitor can decrease
           serum PSA level and acts as a biomarker to differentiate between chronic inflammation
           and prostate cancer.

        -  Eligible subjects will be randomly assigned to the study and control groups at 2:1
           ratio. The study group will receive doxazosin 4mg every day (QD) plus celecoxib 200mg QD
           for 3 months and the control group will receive doxazosin 4 mg QD for 3 months. Patients
           will be investigated for IPSS, total prostatic volume, transition zone index, maximum
           flow rate, voided volume, postvoid residual, serum PSA, free PSA and serum C-reactive
           protein (CRP) levels at baseline and 3 months after treatment. If the serum PSA levels
           remained higher than 4 ng/mL, patients of either group will be advised to receive
           prostatic biopsy for histopathological investigation.

        -  The prostatic biopsy will be advised at the end of the study in both groups of patients.
           Ten prostatic biopsied strips will be sent to pathological department for investigating
           the existence of prostatic cancer. The other two strips will be stored in liquid
           nitrogen for further investigation of inflammatory biomarkers.

      Data Analysis

        -  The efficacy evaluation will be performed on intention-to-treat populations (ITT) and
           per-protocol populations (PPP) datasets while the safety evaluation will be performed on
           ITT datasets. The primary conclusion will be made for the primary endpoint and secondary
           endpoint on the ITT population.

      Efficacy Endpoint Analysis

        -  Net change of each efficacy item will be analyzed by paired t-test between baseline and
           post-treatment in the treatment group and controlled group. The net changes of each
           efficacy item will be analyzed by ANOVA test to compare between treatment group and
           controlled group. The global assessment by the patients will be analyzed by chi-square
           test between the treatment and controlled group.

        -  All efficacy variables will be reported of respective point estimated and 95% confidence
           interval. Comparison tests will be reported of respective p value.

      Safety Endpoints

        -  Adverse events will be reported by both controlled and treatment groups and by
           physiological systems as appropriate. Incidence of adverse events and the categories of
           adverse event severity between treatments will be analyzed by Cochran-Mantel-Haenszel
           test. The coding system used will be the Coding Symbols for a Thesaurus of Adverse
           Reaction Terms (COSTART).

      Changes in physical examinations will be displayed for each individual system.

        -  All statistical tests used will be two-tailed with α= 0.05.

      Expected Results and Conclusion

        -  Chronic inflammation has been considered a possible but important factor to induce LUTS
           and promote prostatic growth. PSA elevation is a sensitive but not specific sign for
           prostatic cancer. In order to reduce the need for prostatic biopsy in patients with an
           elevated serum PSA level, the results of this study might provide a simple way for
           initial differential diagnosis of chronic inflammation from prostatic cancer. If serum
           PSA can be reduced significantly after celecoxib therapy and the positive biopsy rate of
           the following prostatic biopsy is lower than the control group, we might use this
           treatment for the initial management of high PSA level in men with LUTS/BPH.
           Furthermore, if chronic inflammation of the prostate can be reduced, the bothersome of
           the LUTS as well as voiding condition might be improved. This result can be another
           benefit for men who are suffering from LUTS and worried about surgical intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level
time frame: Baseline and 3 months after initial treatment
description: Efficacy:
Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value
measure: Change From Baseline in the Void Volume (VV)
time frame: Baseline and 3 months after initial treatment
description: Efficacy:
Change from Baseline in the Void Volume (VV) from baseline and 3 months Change = Month 3 minus Baseline value
measure: Change From Baseline in the Maximum Flow Rate (Qmax)
time frame: Baseline and 3 months after initial treatment
description: Efficacy:
Change from Baseline in the maximum flow rate (Qmax) from baseline and 3 months Change = Month 3 minus Baseline value
measure: Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires
time frame: Baseline and 3 months after initial treatment
description: Efficacy:
Change from Baseline in the IPSS Voiding from baseline and 3 months. The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.
The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).
Change = Month 3 minus Baseline value
measure: Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires
time frame: Baseline and 3 months after initial treatment
description: Efficacy:
Change from Baseline in the IPSS Storage from baseline and 3 months The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.
The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).
Change = Month 3 minus Baseline value
measure: Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires
time frame: Baseline and 3 months after initial treatment
description: Efficacy:
Change from Baseline in the International Prostate Symptom Score (IPSS) from baseline and 3 months The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS Voiding), 3 storage questions (IPSS Storage) The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always".
Total IPSS score = IPSS voiding + IPSS Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35
Change = Month 3 minus Baseline value
arm group label: Study group
arm group type: Experimental
description: Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)
arm group label: Control group
arm group type: Experimental
description: Doxazosin 4 mg every day (QD)
intervention type: Drug
intervention name: Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
description: Study group
arm group label: Study group
other name: Doxazosin 4 mg
other name: Celecoxib 200 mg
intervention type: Drug
intervention name: Doxazosin 4 mg every day (QD)
description: Control group
arm group label: Control group
other name: Doxazosin 4 mg
criteria: 
gender: Male
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Hann-Chorng Kuo, M.D.
role: Principal Investigator
affiliation: Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
facility: 
country: Taiwan
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PMID: 18400272
citation: St Sauver JL, Sarma AV, Jacobson DJ, McGree ME, Lieber MM, Girman CJ, Nehra A, Jacobsen SJ. Associations between C-reactive protein and benign prostatic hyperplasia/lower urinary tract symptom outcomes in a population-based cohort. Am J Epidemiol. 2009 Jun 1;169(11):1281-90. doi: 10.1093/aje/kwp085. Epub 2009 Apr 24.
PMID: 19395697
citation: Andersson KE. LUTS treatment: future treatment options. Neurourol Urodyn. 2007 Oct;26(6 Suppl):934-47. doi: 10.1002/nau.20500.
PMID: 17696154
citation: Kuo HC. Videourodynamic analysis of pathophysiology of men with both storage and voiding lower urinary tract symptoms. Urology. 2007 Aug;70(2):272-6. doi: 10.1016/j.urology.2007.03.063.
PMID: 17826488
citation: Di Silverio F, Gentile V, De Matteis A, Mariotti G, Giuseppe V, Luigi PA, Sciarra A. Distribution of inflammation, pre-malignant lesions, incidental carcinoma in histologically confirmed benign prostatic hyperplasia: a retrospective analysis. Eur Urol. 2003 Feb;43(2):164-75. doi: 10.1016/s0302-2838(02)00548-1.
PMID: 12565775
citation: Sciarra A, Mariotti G, Salciccia S, Autran Gomez A, Monti S, Toscano V, Di Silverio F. Prostate growth and inflammation. J Steroid Biochem Mol Biol. 2008 Feb;108(3-5):254-60. doi: 10.1016/j.jsbmb.2007.09.013. Epub 2007 Sep 7.
PMID: 17935971
citation: Sciarra A, Di Silverio F, Salciccia S, Autran Gomez AM, Gentilucci A, Gentile V. Inflammation and chronic prostatic diseases: evidence for a link? Eur Urol. 2007 Oct;52(4):964-72. doi: 10.1016/j.eururo.2007.06.038. Epub 2007 Jul 2.
PMID: 17618043
citation: Alcaraz A, Hammerer P, Tubaro A, Schroder FH, Castro R. Is there evidence of a relationship between benign prostatic hyperplasia and prostate cancer? Findings of a literature review. Eur Urol. 2009 Apr;55(4):864-73. doi: 10.1016/j.eururo.2008.11.011. Epub 2008 Nov 21.
PMID: 19027219
citation: Di Silverio F, Bosman C, Salvatori M, Albanesi L, Proietti Pannunzi L, Ciccariello M, Cardi A, Salvatori G, Sciarra A. Combination therapy with rofecoxib and finasteride in the treatment of men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). Eur Urol. 2005 Jan;47(1):72-8; discussion 78-9. doi: 10.1016/j.eururo.2004.08.024.
PMID: 15582252
citation: Ozdemir I, Bozkurt O, Demir O, Aslan G, Esen AA. Combination therapy with doxazosin and tenoxicam for the management of lower urinary tract symptoms. Urology. 2009 Aug;74(2):431-5. doi: 10.1016/j.urology.2009.01.088. Epub 2009 Jun 7.
PMID: 19501883
citation: Jang J, Park EY, Seo SI, Hwang TK, Kim JC. Effects of intravesical instillation of cyclooxygenase-2 inhibitor on the expression of inducible nitric oxide synthase and nerve growth factor in cyclophosphamide-induced overactive bladder. BJU Int. 2006 Aug;98(2):435-9. doi: 10.1111/j.1464-410X.2006.06207.x.
PMID: 16879691
citation: Falahatkar S, Mokhtari G, Pourreza F, Asgari SA, Kamran AN. Celecoxib for treatment of nocturia caused by benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled study. Urology. 2008 Oct;72(4):813-6. doi: 10.1016/j.urology.2008.04.069. Epub 2008 Aug 9.
PMID: 18692876
citation: Djavan B, Waldert M, Zlotta A, Dobronski P, Seitz C, Remzi M, Borkowski A, Schulman C, Marberger M. Safety and morbidity of first and repeat transrectal ultrasound guided prostate needle biopsies: results of a prospective European prostate cancer detection study. J Urol. 2001 Sep;166(3):856-60.
PMID: 11490233
responsible party type: Principal Investigator
investigator affiliation: Buddhist Tzu Chi General Hospital
investigator full name: Hann-Chorng Kuo
investigator title: Department of Urology
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Celecoxib
mesh term: Doxazosin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 