<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/NCT03237026</url>
  </required_header>
  <id_info>
    <org_study_id>201705032RINA</org_study_id>
    <nct_id>NCT03237026</nct_id>
  </id_info>
  <brief_title>Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients</brief_title>
  <official_title>Decipher the Biology of Lethal Prostate Cancer-Using Urine Metabolomics and Proteomics Profiling to Search for Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to identify potential urine marker metabolites as predictive or prognostic&#xD;
      markers for treatment outcomes in patients with prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center single-arm translational study where patients with prostate cancer&#xD;
      who are about to receive definitive treatments will be invited to participate the study.&#xD;
      After signing the approved informed consent, eligible and consenting subjects will donate&#xD;
      their fresh urine samples for subsequent untargeted metabolomics and proteomics study to&#xD;
      identify potential metabolite and protein markers that are able to predict responses&#xD;
      (including efficacy and side effects) to definitive treatments. All subjects who have&#xD;
      received varied treatment before the study can NOT be recruited.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemical recurrence or progression</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>toxicity profile, survival</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <description>Ttaining chort will be recruited in the first 36 months of the study period to generate the first batch of urine metabolomic and proteomic profiles as predictive and prognostic markers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <description>Validation cohort will be recruited in the next 24 months of the study period .</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention required</intervention_name>
    <description>No intervention required</description>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <biospec_descr>
    <textblock>
      fresh urine samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A. Expected subject number to be enrolled: 360 men at NTUH.&#xD;
&#xD;
          1. Radical prostatectomy (OP, N=100): 50 subjects each for Cohort A and Cohort B,&#xD;
             respectively.&#xD;
&#xD;
          2. Radiotherapy (RT, N=140): 70 subjects each for Cohort A and Cohort B, respectively.&#xD;
&#xD;
          3. Androgen-deprivation therapy (ADT, N=60): 30 subjects each for Cohort A and Cohort B,&#xD;
             respectively&#xD;
&#xD;
          4. Systemic chemotherapy (Chemo, N=60): 30 subjects for Cohort A and Cohort B,&#xD;
             respectively&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who have histopathologically confirmed prostate adenocarcinoma.&#xD;
&#xD;
          2. Subjects who age 30 years to 100 years&#xD;
&#xD;
          3. Subjects who agree to undergo the any of the following four treatments, including&#xD;
             radical prostatectomy, definitive prostate radiotherapy, systemic chemotherapy, and&#xD;
             androgen deprivation therapy for prostate cancer.&#xD;
&#xD;
          4. Subjects who understand and will comply with the entire study procedures, consent to&#xD;
             donate his spot urine (once for 50 ml) for urine metabolomics and proteomic profiling,&#xD;
             and agree with subsequent collection and analysis of his clinical information&#xD;
             including results of biopsy and the details of treatments and outcomes. (Note:&#xD;
             Subjects will be told that the urine metabolomics and proteomics results will not be&#xD;
             revealed to them.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have other cancers that have not been curatively treated or are&#xD;
             disease-free for only 3 years or less. Subjects who have other genitourinary cancers&#xD;
             (urothelial, renal cell, etc) are NOT allowed no matter what the disease-free duration&#xD;
             is. However, subjects who have been curatively treated and are disease-free for 3&#xD;
             years or longer are allowed to be enrolled.&#xD;
&#xD;
          2. Subjects who have severe organ function impairment which may significantly alter&#xD;
             general cell metabolism or proteomics profiles determined by the investigators, such&#xD;
             as Cre &gt; 3.0, HbA1c &gt; 9.0%, symptomatic heart failure, or other symptomatic metabolic&#xD;
             diseases.&#xD;
&#xD;
          3. Subjects who have significant infection or inflammation within 8 weeks of the biopsy.&#xD;
&#xD;
          4. Subjects who are taking medicine(s) that may, deemed by the investigators,&#xD;
             substantially affect cell metabolism and proteomics profiles.&#xD;
&#xD;
          5. Subjects who have a life expectancy less than 12 months.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yeong-Shiau Pu, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Urology, National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chung-Hsin Chen, MD PhD</last_name>
    <phone>886-2-23123456</phone>
    <phone_ext>65242</phone_ext>
    <email>mufasachen@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yeong-Shiau Pu, MD PhD</last_name>
    <phone>886-2-23123456</phone>
    <phone_ext>65254</phone_ext>
    <email>pu5249@ntuh.gov.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Taiwan University</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yeong-Shiau Pu Pu, MD PhD</last_name>
      <phone>886-2-23123456</phone>
      <phone_ext>65254</phone_ext>
      <email>pu5249@ntuh.gov.tw</email>
    </contact>
    <contact_backup>
      <last_name>Chung-Hsin Chen, MD PhD</last_name>
      <phone>886-2-23123456</phone>
      <phone_ext>65242</phone_ext>
      <email>mufasachen@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>November 29, 2020</last_update_submitted>
  <last_update_submitted_qc>November 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>prostatectomy</keyword>
  <keyword>prostate radiotherapy</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>immunotherapy</keyword>
  <keyword>biomarkers</keyword>
  <keyword>metabolomics</keyword>
  <keyword>proteomics</keyword>
  <keyword>urine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</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/NCT03237026
org study id: 201705032RINA
nct id: NCT03237026
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study aims to identify potential urine marker metabolites as predictive or prognostic
      markers for treatment outcomes in patients with prostate cancer.
This is a single-center single-arm translational study where patients with prostate cancer
      who are about to receive definitive treatments will be invited to participate the study.
      After signing the approved informed consent, eligible and consenting subjects will donate
      their fresh urine samples for subsequent untargeted metabolomics and proteomics study to
      identify potential metabolite and protein markers that are able to predict responses
      (including efficacy and side effects) to definitive treatments. All subjects who have
      received varied treatment before the study can NOT be recruited.
observational model: Cohort
time perspective: Prospective
measure: Biochemical recurrence or progression
time frame: 5 years
measure: toxicity profile, survival
time frame: 5 years
arm group label: Cohort A
description: Ttaining chort will be recruited in the first 36 months of the study period to generate the first batch of urine metabolomic and proteomic profiles as predictive and prognostic markers.
arm group label: Cohort B
description: Validation cohort will be recruited in the next 24 months of the study period .
intervention type: Other
intervention name: No intervention required
description: No intervention required
arm group label: Cohort A
arm group label: Cohort B
fresh urine samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 100 Years
healthy volunteers: No
last name: Yeong-Shiau Pu, MD PhD
role: Principal Investigator
affiliation: Department of Urology, National Taiwan University Hospital
last name: Chung-Hsin Chen, MD PhD
phone: 886-2-23123456
phone ext: 65242
email: mufasachen@gmail.com
last name: Yeong-Shiau Pu, MD PhD
phone: 886-2-23123456
phone ext: 65254
email: pu5249@ntuh.gov.tw
facility: 
status: Recruiting
contact: 
contact backup: 
country: Taiwan
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No