<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/NCT01672411</url>
  </required_header>
  <id_info>
    <org_study_id>propsa12</org_study_id>
    <nct_id>NCT01672411</nct_id>
  </id_info>
  <brief_title>Predictive Value of Prostate-specific Antigen Isoform p2psa and Its Derivates in the Diagnosis of Prostate Cancer</brief_title>
  <official_title>Predictive Value of Prostate-specific Antigen Isoform p2psa and Its Derivates, %p2psa and Prostate Health Index in the Detection of Prostate Cancer and in Predicting Aggressive Disease: a Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Of Perugia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Of Perugia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Europe, prostate cancer (PCa) is the most common solid neoplasm, with an incidence rate of&#xD;
      214 cases per 1000 men, outnumbering lung and colorectal cancer. Early detection tests have&#xD;
      been developed in order to identify PCa while it is still confined to the prostate gland.&#xD;
&#xD;
      The two most commonly used tests are digital rectal examination and serum prostate-specific&#xD;
      antigen (PSA) level: however, most of cases is detected in the so called T1c stage, i.e. for&#xD;
      PSA increasing only. As marker, PSA is organ-specific but not cancer-specific, and its levels&#xD;
      may change as result of physical activity, sexual activity, in the presence of benign&#xD;
      prostatic hyperplasia (BPH), acute and chronic prostatitis, as well as in the presence of&#xD;
      PCa.&#xD;
&#xD;
      A total serum PSA of 4.0 ng/ml has traditionally been used as threshold for considering&#xD;
      prostate biopsy and large programs for the early detection of prostate cancer have shown that&#xD;
      almost 70% of cancer cases can be detected using a PSA cutoff of 4.0 ng/ml. However, using a&#xD;
      PSA threshold of 4.0 ng/ml 20% to 25% of prostate cancer cases are not detected&#xD;
      (false-negative) and the false-positive rate is 65%. To improve the usefulness of PSA for&#xD;
      identifying patients who require biopsy, the PSA threshold has been lowered at 2 ng/ml;&#xD;
      moreover, the levels of free and bound PSA have been assessed, together with PSA density (the&#xD;
      rate of PSA over the prostate volume) and PSA velocity (the rate of PSA increase), which seem&#xD;
      to have some validity for detecting prostate cancer.&#xD;
&#xD;
      Recent studies have shown that other new biomarkers could be used in the diagnosis of early&#xD;
      prostate cancer as they showed a higher sensitivity and specificity. In the last two years,&#xD;
      several investigators showed that PSA isoform [-2] proPSA (p2PSA) and its derivatives,&#xD;
      namely, percentage of p2PSA to free PSA (%p2PSA) and the Prostate Health Index [PHI; (p2PSA /&#xD;
      free PSA) × √tPSA)] improve the accuracy of total PSA (tPSA) and percentage of free PSA&#xD;
      (%fPSA) in predicting the presence of PCa at prostate biopsy and they are also related to PCa&#xD;
      aggressiveness at biopsy.&#xD;
&#xD;
      The aim of this study is to confirm the diagnostic and prognostic predictive value of&#xD;
      prostate-specific antigen isoform p2psa and its derivates, %p2psa and prostate health index&#xD;
      in the detection of prostate cancer in patients with a PSA 2-10 ng/ml and/or suspicious DRE.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>diagnosis of prostate cancer</measure>
    <time_frame>6 months</time_frame>
    <description>Analyzing the predictive value of %p2PSA and PHI in comparison with standard test (tPSA, fPSA, %fPSA, PSA density, DRE) in the diagnosis of prostate cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prognosis of prostate cancer</measure>
    <time_frame>6 months</time_frame>
    <description>Analyzing the predictive value of %p2PSA and PHI in comparison with standard test (tPSA, fPSA, %fPSA, PSA density, DRE) in the evaluation of aggressiveness of prostate cancer, based on Gleason score groups at biopsy (low risk 4-6, Intermediate risk =7, high risk &gt;=8).</description>
  </secondary_outcome>
  <enrollment type="Actual">250</enrollment>
  <condition>Prostate Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Urological outpatient clinics of one tertiary university high volume department of urology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men aged 18-75&#xD;
&#xD;
          -  Total serum PSA of 2.0-10 ng/ml at entry and/or suspicious digital rectal examination&#xD;
&#xD;
          -  Patients suitable for prostate biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of PCa&#xD;
&#xD;
          -  Previous prostate biopsy or prostatic surgery&#xD;
&#xD;
          -  History of acute urinary retention within 3 months prior&#xD;
&#xD;
          -  Use of any investigational or marketed 5ARI, anabolic steroids or any drug with&#xD;
             anti-androgenic properties within 12 months prior to screening.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Perugia - Urology Dept</name>
      <address>
        <city>Perugia</city>
        <zip>06100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>February 23, 2013</last_update_submitted>
  <last_update_submitted_qc>February 23, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 26, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Of Perugia</investigator_affiliation>
    <investigator_full_name>Luigi Mearini</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>prostate cancer, PSA, markers, diagnosis, prognosis, pro-PSA</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/NCT01672411
org study id: propsa12
nct id: NCT01672411
lead sponsor: 
has dmc: No
In Europe, prostate cancer (PCa) is the most common solid neoplasm, with an incidence rate of
      214 cases per 1000 men, outnumbering lung and colorectal cancer. Early detection tests have
      been developed in order to identify PCa while it is still confined to the prostate gland.

      The two most commonly used tests are digital rectal examination and serum prostate-specific
      antigen (PSA) level: however, most of cases is detected in the so called T1c stage, i.e. for
      PSA increasing only. As marker, PSA is organ-specific but not cancer-specific, and its levels
      may change as result of physical activity, sexual activity, in the presence of benign
      prostatic hyperplasia (BPH), acute and chronic prostatitis, as well as in the presence of
      PCa.

      A total serum PSA of 4.0 ng/ml has traditionally been used as threshold for considering
      prostate biopsy and large programs for the early detection of prostate cancer have shown that
      almost 70% of cancer cases can be detected using a PSA cutoff of 4.0 ng/ml. However, using a
      PSA threshold of 4.0 ng/ml 20% to 25% of prostate cancer cases are not detected
      (false-negative) and the false-positive rate is 65%. To improve the usefulness of PSA for
      identifying patients who require biopsy, the PSA threshold has been lowered at 2 ng/ml;
      moreover, the levels of free and bound PSA have been assessed, together with PSA density (the
      rate of PSA over the prostate volume) and PSA velocity (the rate of PSA increase), which seem
      to have some validity for detecting prostate cancer.

      Recent studies have shown that other new biomarkers could be used in the diagnosis of early
      prostate cancer as they showed a higher sensitivity and specificity. In the last two years,
      several investigators showed that PSA isoform [-2] proPSA (p2PSA) and its derivatives,
      namely, percentage of p2PSA to free PSA (%p2PSA) and the Prostate Health Index [PHI; (p2PSA /
      free PSA) × √tPSA)] improve the accuracy of total PSA (tPSA) and percentage of free PSA
      (%fPSA) in predicting the presence of PCa at prostate biopsy and they are also related to PCa
      aggressiveness at biopsy.

      The aim of this study is to confirm the diagnostic and prognostic predictive value of
      prostate-specific antigen isoform p2psa and its derivates, %p2psa and prostate health index
      in the detection of prostate cancer in patients with a PSA 2-10 ng/ml and/or suspicious DRE.
observational model: Case-Only
time perspective: Prospective
measure: diagnosis of prostate cancer
time frame: 6 months
description: Analyzing the predictive value of %p2PSA and PHI in comparison with standard test (tPSA, fPSA, %fPSA, PSA density, DRE) in the diagnosis of prostate cancer.
measure: prognosis of prostate cancer
time frame: 6 months
description: Analyzing the predictive value of %p2PSA and PHI in comparison with standard test (tPSA, fPSA, %fPSA, PSA density, DRE) in the evaluation of aggressiveness of prostate cancer, based on Gleason score groups at biopsy (low risk 4-6, Intermediate risk =7, high risk >=8).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University Of Perugia
investigator full name: Luigi Mearini
investigator title: Dr
mesh term: Prostatic Neoplasms