xml: <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/NCT06001619</url>
    </required_header>
    <id_info>
      <org_study_id>2022-500618-24-00</org_study_id>
      <nct_id>NCT06001619</nct_id>
    </id_info>
    <brief_title>Prostate Medication, Metabolism and Gut Microbiota</brief_title>
    <acronym>PROMED</acronym>
    <official_title>Prostate Medication, Metabolism and Gut Microbiota</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Turku University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Turku University Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        PROMED is a prospective, single center translational multiple cohort study to investigate the&#xD;
        association of prostate medication and gut microbiota. The main aim is to investigate how&#xD;
        prostate hormonal therapy (5-ARI, ADT) affects gut microbiota composition. Aalso study&#xD;
        metabolic characteristics in the gut and systemic circulation in men with different&#xD;
        medications will be studied. In addition, the effect of gut microbiota on patient's response&#xD;
        to medications will be investigated. The medicines used in the study to treat benign prostate&#xD;
        hyperplasia are dutasteride and finasteride and a combination of dutasteride and tamsulosin.&#xD;
        LHRH antagonist degarelix is used as a medication to treat patients with cancer. The dosages&#xD;
        of 5-ARI medication: dutasteride 0,5mg x1 or finasteride 5mg x1 or combination of dutasteride&#xD;
        and tamsulosin 0,5/0,4mg x1. The starting dose of LHRH antagonist degarelix is 120mgx2 and&#xD;
        the maintenance dose is 80mgx1. The medication for PCa is planned according to the protocol&#xD;
        but so that each subject receives degarelix at the beginning of treatment and one month after&#xD;
        initiation. Thereafter, the medication is continued according to the clinician's assessment.&#xD;
        The study is carried out in Turku University Hospital and University of Turku.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Prostate cancer (PCa) is a significant health care system challenge. PCa is the most common&#xD;
        male cancer in Finland and most western countries. Interestingly, although the incidence of&#xD;
        indolent (latent) PCa is very similar throughout the globe, there is a remarkable global&#xD;
        age-adjusted incidence variation (up to 40-fold difference between highest and lowest&#xD;
        incidences).&#xD;
  &#xD;
        Epidemiological data suggest that aging in men is associated with neoplastic processes in the&#xD;
        prostate but only a subset of men will develop a true malignancy potentially affecting their&#xD;
        life-span or quality of life. Genetic factors have a significant effect on PCa risk, but very&#xD;
        likely life-style (e.g. diet and physical activity) affect PCa risk as well, but the&#xD;
        mechanisms mediating protective or harmful effects of life-style remain unclear.&#xD;
  &#xD;
        Gut microbiota, i.e. the collection of microbes colonizing the gastrointestinal tract, is&#xD;
        acknowledged to play significant role in many metabolic pathways and pathogenic processes in&#xD;
        the human body. Although there is some evidence suggesting that gut microbiota affects&#xD;
        therapy responses (especially androgen deprivation) in PCa, it ́s potential role in prostate&#xD;
        carcinogenesis is not well documented. Our previous studies suggest that gut microbiota&#xD;
        composition is different in men with and without PCa and that changes in steroid hormone&#xD;
        synthesis may be one mechanism how gut microbiota affects PCa risk.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gut microbiota signature before 5-ARI therapy</measure>
      <time_frame>before starting prostate 5-ARI medication</time_frame>
      <description>Gut microbiota signature before 5-ARI therapy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gut microbiota signature after 5-ARI therapy</measure>
      <time_frame>2 months after starting prostate 5-ARI medication</time_frame>
      <description>Gut microbiota signature after 5-ARI therapy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gut microbiota signature before ADT (LHRH antagonists).</measure>
      <time_frame>before starting prostate degarelix</time_frame>
      <description>Gut microbiota signature before ADT (LHRH antagonists).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gut microbiota signature after ADT (LHRH antagonists).</measure>
      <time_frame>2 months after starting prostate degarelix</time_frame>
      <description>Gut microbiota signature after ADT (LHRH antagonists).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Metabolic characteristics in the gut and systemic circulation after use of prostate medication</measure>
      <time_frame>before starting prostate idcation (degarelix or finasteride/dutasteride)</time_frame>
      <description>Gut metabolic charachteristics of men receiving prostate medication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Metabolic characteristics in the gut and systemic circulation before iuse of prostate medication</measure>
      <time_frame>2 months after from starting prostate medication (degarelix or finasteride/d</time_frame>
      <description>Gut metabolic charachteristics of men receiving prostate medication</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Prostatic Hyperplasia</condition>
    <condition>Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>Prostatic hyperplasia</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Inclusion criteria for the BPH cohort includes clinical decision to initiate treatment of benign prostate hyperplasia (BPH) with 5-alpha-reductase inhibitors (finasteride, dutasteride, or combination of dutasteride and tamsulosin). Before starting the medication, size of the prostate has been measured with TRUS (transrectal ultrasound). The BPH cohort will include a total of 50 subjects and the study samples (gut microbiota, metabolite sampling) will be collected prior the start of the 5-alpha- reductase inhibitors and after 2 months of medical therapy. At this stage, PSA is determined from blood sample and the size of the prostate is measured with transrectal ultrasound (TRUS). In addition, after 6 months, PSA and prostate size measurements are repeated.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prostatic cancer</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Inclusion criteria for the cancer cohort include a clinical decision to initiate PCa treatment with androgen deprivation therapy (ADT) with LHRH antagonist (degarelix). This may include either treatment of a metastatic disease with definite ADT or adjuvant ADT to external beam radiation of the prostate. The cancer cohort will include a total of 50 subjects and the study samples (gut microbiota, metabolite sampling) will be collected prior the start of the ADT and after 2 months of medical therapy. In addition, after 2 and 6 months, PSA measurement is repeated.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Prostate hyperplasia medication</intervention_name>
      <description>The dosages prostatic hyperplasia medication: dutasteride 0,5 MG x1 or finasteride 5 MG x1 or combination of dutasteride and tamsulosin 0,5/0,4 MG x1.</description>
      <arm_group_label>Prostatic hyperplasia</arm_group_label>
      <other_name>Finasteride 5 MG</other_name>
      <other_name>Dutasteride 0,5 MG</other_name>
      <other_name>Dutasteride and Tamsulosin 0,5/0,4 MG</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LhRH-antagonist</intervention_name>
      <description>The starting dose in prostatic cancer patient cohort of LHRH antagonist degarelix is 120 MGx2 and the maintenance dose is 80 MGx1.</description>
      <arm_group_label>Prostatic cancer</arm_group_label>
      <other_name>Degarelix 120 MG</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provision of signed and dated informed consent form.&#xD;
  &#xD;
            -  Ability and stated willingness to comply with all study procedures and availability&#xD;
               for the duration of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any history of a fecal transplantation.&#xD;
  &#xD;
            -  Recent (within 3 months or still symptomatic) gastroenteritis.&#xD;
  &#xD;
            -  Antibiotic treatment within 3 months (expect for antibiotic prophylaxis related to&#xD;
               prostate biopsies).&#xD;
  &#xD;
            -  Inability to comply with the protocol of unwillingness to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Prostatic diseases</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Peter Bostrom, MD, FEBU</last_name>
      <phone>+35823135925</phone>
      <email>peter.bostrom@tyks.fi</email>
    </overall_contact>
    <location>
      <facility>
        <name>Turku University Hospital</name>
        <address>
          <city>Turku</city>
          <zip>20100</zip>
          <country>Finland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Peter Bostrom, MD</last_name>
      </contact>
      <investigator>
        <last_name>Peter Bostrom, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Turku</name>
        <address>
          <city>Turku</city>
          <zip>20100</zip>
          <country>Finland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Peter J Bostrom, MD, PhD</last_name>
        <phone>+358-2-3135925</phone>
        <email>peter.bostrom@tyks.fi</email>
      </contact>
      <investigator>
        <last_name>Antti Salminen, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Finland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic 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>Tamsulosin</mesh_term>
      <mesh_term>Finasteride</mesh_term>
      <mesh_term>Dutasteride</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001619
  org study id: 2022-500618-24-00
  nct id: NCT06001619
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  PROMED is a prospective, single center translational multiple cohort study to investigate the
        association of prostate medication and gut microbiota. The main aim is to investigate how
        prostate hormonal therapy (5-ARI, ADT) affects gut microbiota composition. Aalso study
        metabolic characteristics in the gut and systemic circulation in men with different
        medications will be studied. In addition, the effect of gut microbiota on patient's response
        to medications will be investigated. The medicines used in the study to treat benign prostate
        hyperplasia are dutasteride and finasteride and a combination of dutasteride and tamsulosin.
        LHRH antagonist degarelix is used as a medication to treat patients with cancer. The dosages
        of 5-ARI medication: dutasteride 0,5mg x1 or finasteride 5mg x1 or combination of dutasteride
        and tamsulosin 0,5/0,4mg x1. The starting dose of LHRH antagonist degarelix is 120mgx2 and
        the maintenance dose is 80mgx1. The medication for PCa is planned according to the protocol
        but so that each subject receives degarelix at the beginning of treatment and one month after
        initiation. Thereafter, the medication is continued according to the clinician's assessment.
        The study is carried out in Turku University Hospital and University of Turku.
  Prostate cancer (PCa) is a significant health care system challenge. PCa is the most common
        male cancer in Finland and most western countries. Interestingly, although the incidence of
        indolent (latent) PCa is very similar throughout the globe, there is a remarkable global
        age-adjusted incidence variation (up to 40-fold difference between highest and lowest
        incidences).
  
        Epidemiological data suggest that aging in men is associated with neoplastic processes in the
        prostate but only a subset of men will develop a true malignancy potentially affecting their
        life-span or quality of life. Genetic factors have a significant effect on PCa risk, but very
        likely life-style (e.g. diet and physical activity) affect PCa risk as well, but the
        mechanisms mediating protective or harmful effects of life-style remain unclear.
  
        Gut microbiota, i.e. the collection of microbes colonizing the gastrointestinal tract, is
        acknowledged to play significant role in many metabolic pathways and pathogenic processes in
        the human body. Although there is some evidence suggesting that gut microbiota affects
        therapy responses (especially androgen deprivation) in PCa, it ́s potential role in prostate
        carcinogenesis is not well documented. Our previous studies suggest that gut microbiota
        composition is different in men with and without PCa and that changes in steroid hormone
        synthesis may be one mechanism how gut microbiota affects PCa risk.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Gut microbiota signature before 5-ARI therapy
  time frame: before starting prostate 5-ARI medication
  description: Gut microbiota signature before 5-ARI therapy
  measure: Gut microbiota signature after 5-ARI therapy
  time frame: 2 months after starting prostate 5-ARI medication
  description: Gut microbiota signature after 5-ARI therapy
  measure: Gut microbiota signature before ADT (LHRH antagonists).
  time frame: before starting prostate degarelix
  description: Gut microbiota signature before ADT (LHRH antagonists).
  measure: Gut microbiota signature after ADT (LHRH antagonists).
  time frame: 2 months after starting prostate degarelix
  description: Gut microbiota signature after ADT (LHRH antagonists).
  measure: Metabolic characteristics in the gut and systemic circulation after use of prostate medication
  time frame: before starting prostate idcation (degarelix or finasteride/dutasteride)
  description: Gut metabolic charachteristics of men receiving prostate medication
  measure: Metabolic characteristics in the gut and systemic circulation before iuse of prostate medication
  time frame: 2 months after from starting prostate medication (degarelix or finasteride/d
  description: Gut metabolic charachteristics of men receiving prostate medication
  arm group label: Prostatic hyperplasia
  arm group type: Experimental
  description: Inclusion criteria for the BPH cohort includes clinical decision to initiate treatment of benign prostate hyperplasia (BPH) with 5-alpha-reductase inhibitors (finasteride, dutasteride, or combination of dutasteride and tamsulosin). Before starting the medication, size of the prostate has been measured with TRUS (transrectal ultrasound). The BPH cohort will include a total of 50 subjects and the study samples (gut microbiota, metabolite sampling) will be collected prior the start of the 5-alpha- reductase inhibitors and after 2 months of medical therapy. At this stage, PSA is determined from blood sample and the size of the prostate is measured with transrectal ultrasound (TRUS). In addition, after 6 months, PSA and prostate size measurements are repeated.
  arm group label: Prostatic cancer
  arm group type: Experimental
  description: Inclusion criteria for the cancer cohort include a clinical decision to initiate PCa treatment with androgen deprivation therapy (ADT) with LHRH antagonist (degarelix). This may include either treatment of a metastatic disease with definite ADT or adjuvant ADT to external beam radiation of the prostate. The cancer cohort will include a total of 50 subjects and the study samples (gut microbiota, metabolite sampling) will be collected prior the start of the ADT and after 2 months of medical therapy. In addition, after 2 and 6 months, PSA measurement is repeated.
  intervention type: Drug
  intervention name: Prostate hyperplasia medication
  description: The dosages prostatic hyperplasia medication: dutasteride 0,5 MG x1 or finasteride 5 MG x1 or combination of dutasteride and tamsulosin 0,5/0,4 MG x1.
  arm group label: Prostatic hyperplasia
  other name: Finasteride 5 MG
  other name: Dutasteride 0,5 MG
  other name: Dutasteride and Tamsulosin 0,5/0,4 MG
  intervention type: Drug
  intervention name: LhRH-antagonist
  description: The starting dose in prostatic cancer patient cohort of LHRH antagonist degarelix is 120 MGx2 and the maintenance dose is 80 MGx1.
  arm group label: Prostatic cancer
  other name: Degarelix 120 MG
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Prostatic diseases
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Peter Bostrom, MD, FEBU
  phone: +35823135925
  email: peter.bostrom@tyks.fi
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Finland
  responsible party type: Sponsor
  mesh term: Prostatic Hyperplasia
  mesh term: Hyperplasia
  mesh term: Tamsulosin
  mesh term: Finasteride
  mesh term: Dutasteride