<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/NCT04487847</url>
  </required_header>
  <id_info>
    <org_study_id>NL73559.091.20</org_study_id>
    <nct_id>NCT04487847</nct_id>
  </id_info>
  <brief_title>18F-PSMA-1007 PET Imaging to Detect Primary Prostate Cancer</brief_title>
  <acronym>PICture</acronym>
  <official_title>18F-PSMA-1007 PET to Detect Primary Prostate Cancer: a Comparative Study With mpMRI and Correlation to Histopathology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ABX advanced biochemical compounds GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the added value of 18F-PSMA-1007 PET to mpMRI in the detection of local prostate&#xD;
      cancer lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer (PCa) is the second most common diagnosed malignancy in males worldwide, with&#xD;
      over 1.2 million new patients diagnosed every year. Since the introduction of&#xD;
      prostate-specific antigen (PSA) the primary diagnosis consisted of histologic confirmation by&#xD;
      transrectal ultrasound (TRUS) systematic biopsies. However, in recent years this has changed&#xD;
      into performing multi-parametric MR imaging (mpMRI) prior to prostate biopsy.&#xD;
&#xD;
      MpMRI has proven to be a valuable tool to avoid unnecessary prostate biopsies and prevent&#xD;
      over-treatment of low-grade PCa, while maintaining equal or higher detection rates of&#xD;
      high-grade PCa. Prostate MRI is evaluated using the Prostate Imaging-Reporting and Data&#xD;
      System (PIRADS). Lesions are given a category score, from 1 (high-grade PCa is unlikely to be&#xD;
      present) to 5 (presence of high-grade PCa is highly likely). A PIRADS 3 is an equivocal scan.&#xD;
      Nonetheless, mpMRI has room for improvement as its specificity for high-grade tumors is only&#xD;
      73% and local staging is limited with mpMRI. Also, the mpMRI is frequently unclear as 4-39%&#xD;
      of detected lesions are classified as PIRADS 3.&#xD;
&#xD;
      Prostate-specific membrane antigen receptor (PSMA) is highly overexpressed by 95% of the&#xD;
      prostate cancer cells and seem to positively correlate to aggressiveness of the tumor.&#xD;
      PSMA-positron emission tomography (PET) uses this feature by visualizing PSMA expressing&#xD;
      prostate tumors. Currently, the PSMA-PET is generally used to detect recurrences or&#xD;
      metastases. However, there is an increasing interest for PSMA-PET scans in patients with a&#xD;
      primary diagnosis of PCa for staging purposes. Yet, there is no published data on the role of&#xD;
      PSMA-PET on PCa prior to biopsy in comparison to the detection rate of mpMRI and&#xD;
      histopathology.&#xD;
&#xD;
      This study aims to investigate the added value of a 18F-PSMA-PET to mpMRI in the detection of&#xD;
      local prostate cancer lesions.&#xD;
&#xD;
      75 patients with the suspicion on prostate cancer (e.g. elevated PSA and/or abnormal digital&#xD;
      rectal exam) will receive a 18F-PSMA-1007 PET following mpMRI. 25 patients with PIRADS 1-2&#xD;
      (probably benign disease), 25 patients with PIRADS 3 (equivocal disease) and 25 patients with&#xD;
      PIRADS 4-5 (highly suspicious for malignancy) will be included in this study.&#xD;
&#xD;
      If either the mpMRI or 18F-PSMA-1007 PET shows a potential malignant lesion, a (target)&#xD;
      biopsy will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">February 28, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <intervention_model_description>Explorative study of 18F-PSMA-1007 PET to detect prostate cancer</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare mpMRI,18F-PSMA-1007 PET and histopathology.</measure>
    <time_frame>30 days</time_frame>
    <description>Within each of the three PIRADS groups (1-2, 3, 4-5) the fraction of patients in which the diagnosis based on mpMRI and 18F-PSMA-1007 PET differ is evaluated.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>PIRADS 1-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 patients with PIRADS 1-2 (probably benign) on mpMRI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PIRADS 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 patients with PIRADS 3 (equivocal scan) on mpMRI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PIRADS 4-5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 patients with PIRADS 4-5 (probably malignant) on mpMRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>18F-PSMA-1007 PET/CT</intervention_name>
    <description>18F-PSMA-1007 PET/CT</description>
    <arm_group_label>PIRADS 1-2</arm_group_label>
    <arm_group_label>PIRADS 3</arm_group_label>
    <arm_group_label>PIRADS 4-5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspicion for PCa (e.g. elevated PSA, suspicious rectal examination)&#xD;
&#xD;
          -  Males ≥ 18 years&#xD;
&#xD;
          -  ECOG 0-1&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prostate biopsy in the last 6 months&#xD;
&#xD;
          -  History of prostate cancer&#xD;
&#xD;
          -  Second active malignancy&#xD;
&#xD;
          -  Any prior surgery in the pelvic area that might interfere with the scans (e.g. hip&#xD;
             replacement surgery)&#xD;
&#xD;
          -  Any medical condition that in the opinion of the investigator will affect patients'&#xD;
             clinical status when participating in this trial.&#xD;
&#xD;
          -  Contra-indications for mpMRI or PET: claustrophobia or inability to lay still for the&#xD;
             duration of the exam.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Prostate cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Radboud University</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Woo S, Suh CH, Kim SY, Cho JY, Kim SH. Diagnostic Performance of Prostate Imaging Reporting and Data System Version 2 for Detection of Prostate Cancer: A Systematic Review and Diagnostic Meta-analysis. Eur Urol. 2017 Aug;72(2):177-188. doi: 10.1016/j.eururo.2017.01.042. Epub 2017 Feb 11.</citation>
    <PMID>28196723</PMID>
  </reference>
  <results_reference>
    <citation>Barentsz JO, Weinreb JC, Verma S, Thoeny HC, Tempany CM, Shtern F, Padhani AR, Margolis D, Macura KJ, Haider MA, Cornud F, Choyke PL. Synopsis of the PI-RADS v2 Guidelines for Multiparametric Prostate Magnetic Resonance Imaging and Recommendations for Use. Eur Urol. 2016 Jan;69(1):41-9. doi: 10.1016/j.eururo.2015.08.038. Epub 2015 Sep 8. No abstract available.</citation>
    <PMID>26361169</PMID>
  </results_reference>
  <results_reference>
    <citation>de Rooij M, Hamoen EH, Witjes JA, Barentsz JO, Rovers MM. Accuracy of Magnetic Resonance Imaging for Local Staging of Prostate Cancer: A Diagnostic Meta-analysis. Eur Urol. 2016 Aug;70(2):233-45. doi: 10.1016/j.eururo.2015.07.029. Epub 2015 Jul 26.</citation>
    <PMID>26215604</PMID>
  </results_reference>
  <results_reference>
    <citation>van der Leest M, Cornel E, Israel B, Hendriks R, Padhani AR, Hoogenboom M, Zamecnik P, Bakker D, Setiasti AY, Veltman J, van den Hout H, van der Lelij H, van Oort I, Klaver S, Debruyne F, Sedelaar M, Hannink G, Rovers M, Hulsbergen-van de Kaa C, Barentsz JO. Head-to-head Comparison of Transrectal Ultrasound-guided Prostate Biopsy Versus Multiparametric Prostate Resonance Imaging with Subsequent Magnetic Resonance-guided Biopsy in Biopsy-naive Men with Elevated Prostate-specific Antigen: A Large Prospective Multicenter Clinical Study. Eur Urol. 2019 Apr;75(4):570-578. doi: 10.1016/j.eururo.2018.11.023. Epub 2018 Nov 23.</citation>
    <PMID>30477981</PMID>
  </results_reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>August 4, 2023</last_update_submitted>
  <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate cancer</keyword>
  <keyword>Staging</keyword>
  <keyword>PET imaging</keyword>
  <keyword>PSMA-1007</keyword>
  <keyword>mpMRI</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>Undecided</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/NCT04487847
org study id: NL73559.091.20
nct id: NCT04487847
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To study the added value of 18F-PSMA-1007 PET to mpMRI in the detection of local prostate
      cancer lesions.
Prostate cancer (PCa) is the second most common diagnosed malignancy in males worldwide, with
      over 1.2 million new patients diagnosed every year. Since the introduction of
      prostate-specific antigen (PSA) the primary diagnosis consisted of histologic confirmation by
      transrectal ultrasound (TRUS) systematic biopsies. However, in recent years this has changed
      into performing multi-parametric MR imaging (mpMRI) prior to prostate biopsy.

      MpMRI has proven to be a valuable tool to avoid unnecessary prostate biopsies and prevent
      over-treatment of low-grade PCa, while maintaining equal or higher detection rates of
      high-grade PCa. Prostate MRI is evaluated using the Prostate Imaging-Reporting and Data
      System (PIRADS). Lesions are given a category score, from 1 (high-grade PCa is unlikely to be
      present) to 5 (presence of high-grade PCa is highly likely). A PIRADS 3 is an equivocal scan.
      Nonetheless, mpMRI has room for improvement as its specificity for high-grade tumors is only
      73% and local staging is limited with mpMRI. Also, the mpMRI is frequently unclear as 4-39%
      of detected lesions are classified as PIRADS 3.

      Prostate-specific membrane antigen receptor (PSMA) is highly overexpressed by 95% of the
      prostate cancer cells and seem to positively correlate to aggressiveness of the tumor.
      PSMA-positron emission tomography (PET) uses this feature by visualizing PSMA expressing
      prostate tumors. Currently, the PSMA-PET is generally used to detect recurrences or
      metastases. However, there is an increasing interest for PSMA-PET scans in patients with a
      primary diagnosis of PCa for staging purposes. Yet, there is no published data on the role of
      PSMA-PET on PCa prior to biopsy in comparison to the detection rate of mpMRI and
      histopathology.

      This study aims to investigate the added value of a 18F-PSMA-PET to mpMRI in the detection of
      local prostate cancer lesions.

      75 patients with the suspicion on prostate cancer (e.g. elevated PSA and/or abnormal digital
      rectal exam) will receive a 18F-PSMA-1007 PET following mpMRI. 25 patients with PIRADS 1-2
      (probably benign disease), 25 patients with PIRADS 3 (equivocal disease) and 25 patients with
      PIRADS 4-5 (highly suspicious for malignancy) will be included in this study.

      If either the mpMRI or 18F-PSMA-1007 PET shows a potential malignant lesion, a (target)
      biopsy will be performed.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Explorative study of 18F-PSMA-1007 PET to detect prostate cancer
primary purpose: Diagnostic
masking: None (Open Label)
measure: Compare mpMRI,18F-PSMA-1007 PET and histopathology.
time frame: 30 days
description: Within each of the three PIRADS groups (1-2, 3, 4-5) the fraction of patients in which the diagnosis based on mpMRI and 18F-PSMA-1007 PET differ is evaluated.
arm group label: PIRADS 1-2
arm group type: Experimental
description: 25 patients with PIRADS 1-2 (probably benign) on mpMRI
arm group label: PIRADS 3
arm group type: Experimental
description: 25 patients with PIRADS 3 (equivocal scan) on mpMRI
arm group label: PIRADS 4-5
arm group type: Experimental
description: 25 patients with PIRADS 4-5 (probably malignant) on mpMRI
intervention type: Diagnostic Test
intervention name: 18F-PSMA-1007 PET/CT
description: 18F-PSMA-1007 PET/CT
arm group label: PIRADS 1-2
arm group label: PIRADS 3
arm group label: PIRADS 4-5
criteria: 
gender: Male
gender based: Yes
gender description: Prostate cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
citation: Woo S, Suh CH, Kim SY, Cho JY, Kim SH. Diagnostic Performance of Prostate Imaging Reporting and Data System Version 2 for Detection of Prostate Cancer: A Systematic Review and Diagnostic Meta-analysis. Eur Urol. 2017 Aug;72(2):177-188. doi: 10.1016/j.eururo.2017.01.042. Epub 2017 Feb 11.
PMID: 28196723
citation: Barentsz JO, Weinreb JC, Verma S, Thoeny HC, Tempany CM, Shtern F, Padhani AR, Margolis D, Macura KJ, Haider MA, Cornud F, Choyke PL. Synopsis of the PI-RADS v2 Guidelines for Multiparametric Prostate Magnetic Resonance Imaging and Recommendations for Use. Eur Urol. 2016 Jan;69(1):41-9. doi: 10.1016/j.eururo.2015.08.038. Epub 2015 Sep 8. No abstract available.
PMID: 26361169
citation: de Rooij M, Hamoen EH, Witjes JA, Barentsz JO, Rovers MM. Accuracy of Magnetic Resonance Imaging for Local Staging of Prostate Cancer: A Diagnostic Meta-analysis. Eur Urol. 2016 Aug;70(2):233-45. doi: 10.1016/j.eururo.2015.07.029. Epub 2015 Jul 26.
PMID: 26215604
citation: van der Leest M, Cornel E, Israel B, Hendriks R, Padhani AR, Hoogenboom M, Zamecnik P, Bakker D, Setiasti AY, Veltman J, van den Hout H, van der Lelij H, van Oort I, Klaver S, Debruyne F, Sedelaar M, Hannink G, Rovers M, Hulsbergen-van de Kaa C, Barentsz JO. Head-to-head Comparison of Transrectal Ultrasound-guided Prostate Biopsy Versus Multiparametric Prostate Resonance Imaging with Subsequent Magnetic Resonance-guided Biopsy in Biopsy-naive Men with Elevated Prostate-specific Antigen: A Large Prospective Multicenter Clinical Study. Eur Urol. 2019 Apr;75(4):570-578. doi: 10.1016/j.eururo.2018.11.023. Epub 2018 Nov 23.
PMID: 30477981
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: Undecided