<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/NCT02241122</url>
  </required_header>
  <id_info>
    <org_study_id>72/1801/2014</org_study_id>
    <nct_id>NCT02241122</nct_id>
  </id_info>
  <brief_title>MRI and Biomarkers in Prostate Cancer</brief_title>
  <acronym>Multi-IMPROD</acronym>
  <official_title>Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging Targeted Biopsies and Biomarkers (Multi-institutional Study)</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prostate cancer has been the most common neoplastic disease in men in Finland over the last&#xD;
      ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate&#xD;
      cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection.&#xD;
      Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS)&#xD;
      guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed&#xD;
      instead of targeted TRUS biopsy. As biopsy carries a significant risk of complications, there&#xD;
      is an increasing interest in developing more accurate non-invasive imaging modalities.&#xD;
&#xD;
      This prospective multi-institutional study will enroll 400 men with clinical suspicion of&#xD;
      prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital&#xD;
      rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted&#xD;
      imaging (DWI) at 1.5/3 Tesla (T) magnetic field using surface coils will be used to&#xD;
      non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided&#xD;
      biopsy based on MRI findings will be performed in addition to routine twelve core TRUS&#xD;
      biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from&#xD;
      fresh biopsy sample will be collected and correlated with the presence or absence of prostate&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy of biparametric MRI (T2wi+DWI) in prostate cancer diagnosis</measure>
    <time_frame>18 months</time_frame>
    <description>Biparametric MRI (T2wi+DWI) is performed in patients with a clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE). The accuracy will be determined using the results from transrectal ultrasound guided biopsies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis</measure>
    <time_frame>18 months</time_frame>
    <description>Accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis will be evaluated.&#xD;
Gene expression profile of selected genes will be compared between cancer and non-cancer cases to investage optimal gene expression panels for prostate cancer risk prediction. Similarly serum and urine marker profiles are compared between cancer and non-cancer cases</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Evaluation of bacterial strains</measure>
    <time_frame>18 months</time_frame>
    <description>The bacterial resistance towards antibiotics is evaluated.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>MRI guided prostate biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>prostate biopsy after MR-imaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>prostate biopsy</intervention_name>
    <arm_group_label>MRI guided prostate biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 to 85 years&#xD;
&#xD;
          -  Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to&#xD;
             20 ng/ml in two following measurements and/or abnormal digital rectal examination&#xD;
&#xD;
          -  Mental status: Patients must be able to understand the meaning of the study&#xD;
&#xD;
          -  Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved&#xD;
             informed consent documents in the presence of the designated staff&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous prostate biopsies within 6 months&#xD;
&#xD;
          -  previous diagnosis of prostate carcinoma&#xD;
&#xD;
          -  previous prostate surgeries, e.g. TURP (transurethral prostatic resection)&#xD;
&#xD;
          -  symptomatic of acute prostatitis&#xD;
&#xD;
          -  contraindications for MRI (cardiac pacemaker, intracranial clips etc)&#xD;
&#xD;
          -  uncontrolled serious infection&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  hip replacement surgery or other metal implants in the pelvic area&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Boström, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Urology, University of Turku and Turku University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Urology, Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Urology, Kuopio University Hospital</name>
      <address>
        <city>Kuopio</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Urology, Pori Central Hospital</name>
      <address>
        <city>Pori</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Urology, Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <zip>2050</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <reference>
    <citation>Jambor I, Kahkonen E, Taimen P, Merisaari H, Saunavaara J, Alanen K, Obsitnik B, Minn H, Lehotska V, Aronen HJ. Prebiopsy multiparametric 3T prostate MRI in patients with elevated PSA, normal digital rectal examination, and no previous biopsy. J Magn Reson Imaging. 2015 May;41(5):1394-404. doi: 10.1002/jmri.24682. Epub 2014 Jun 23.</citation>
    <PMID>24956412</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>PSA</keyword>
  <keyword>MRI</keyword>
  <keyword>biopsy</keyword>
  <keyword>biomarker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02241122
org study id: 72/1801/2014
nct id: NCT02241122
lead sponsor: 
has dmc: No
Prostate cancer has been the most common neoplastic disease in men in Finland over the last
      ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate
      cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection.
      Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS)
      guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed
      instead of targeted TRUS biopsy. As biopsy carries a significant risk of complications, there
      is an increasing interest in developing more accurate non-invasive imaging modalities.

      This prospective multi-institutional study will enroll 400 men with clinical suspicion of
      prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital
      rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted
      imaging (DWI) at 1.5/3 Tesla (T) magnetic field using surface coils will be used to
      non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided
      biopsy based on MRI findings will be performed in addition to routine twelve core TRUS
      biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from
      fresh biopsy sample will be collected and correlated with the presence or absence of prostate
      cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic accuracy of biparametric MRI (T2wi+DWI) in prostate cancer diagnosis
time frame: 18 months
description: Biparametric MRI (T2wi+DWI) is performed in patients with a clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE). The accuracy will be determined using the results from transrectal ultrasound guided biopsies.
measure: Diagnostic accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis
time frame: 18 months
description: Accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis will be evaluated.
Gene expression profile of selected genes will be compared between cancer and non-cancer cases to investage optimal gene expression panels for prostate cancer risk prediction. Similarly serum and urine marker profiles are compared between cancer and non-cancer cases
measure: Evaluation of bacterial strains
time frame: 18 months
description: The bacterial resistance towards antibiotics is evaluated.
arm group label: MRI guided prostate biopsy
arm group type: Experimental
description: prostate biopsy after MR-imaging
intervention type: Procedure
intervention name: prostate biopsy
arm group label: MRI guided prostate biopsy
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Peter Boström, MD, PhD
role: Principal Investigator
affiliation: Department of Urology, University of Turku and Turku University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
country: Finland
citation: Jambor I, Kahkonen E, Taimen P, Merisaari H, Saunavaara J, Alanen K, Obsitnik B, Minn H, Lehotska V, Aronen HJ. Prebiopsy multiparametric 3T prostate MRI in patients with elevated PSA, normal digital rectal examination, and no previous biopsy. J Magn Reson Imaging. 2015 May;41(5):1394-404. doi: 10.1002/jmri.24682. Epub 2014 Jun 23.
PMID: 24956412
responsible party type: Sponsor
mesh term: Prostatic Neoplasms