<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/NCT04462926</url>
  </required_header>
  <id_info>
    <org_study_id>ND</org_study_id>
    <secondary_id>2019-004685-18</secondary_id>
    <nct_id>NCT04462926</nct_id>
  </id_info>
  <brief_title>Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed</brief_title>
  <acronym>PSMA-PROSTAPET</acronym>
  <official_title>Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliero-Universitaria di Modena</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliero-Universitaria di Modena</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>
      This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment&#xD;
      interventional study.&#xD;
&#xD;
      Its aim is to evaluate the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in detection of&#xD;
      primary tumour and extra prostatic disease (lymph node, soft tissues spread or bone&#xD;
      metastases) in men newly diagnosed with Prostate Cancer at Intermediate and High Risk,&#xD;
      according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study&#xD;
      Population paragraph).&#xD;
&#xD;
      The investigators are interested in the possible future role of [68Ga]Ga-labelled PSMA PET/CT&#xD;
      as integration to conventional imaging mpMRI (with or without CT of the lower abdomen and&#xD;
      Bone scan) in the detection of primary tumor and extra-prostatic disease (lymph node and soft&#xD;
      tissues spread or bone metastases).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment&#xD;
      interventional study.&#xD;
&#xD;
      The primary objective of this study is to evaluate the diagnostic accuracy of&#xD;
      [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node,&#xD;
      soft tissues spread or bone metastases) in men newly diagnosed with prostate cancer at&#xD;
      intermediate or high-risk.&#xD;
&#xD;
      The secondary objective of this study is to compare the diagnostic accuracy of&#xD;
      [68Ga]Ga-PSMA-11 PET/CT to the diagnostic accuracy of conventional imaging mpMRI (with or&#xD;
      without CT of the lower abdomen and Bone scan) in the prostatic bed and extra prostatic&#xD;
      disease in men newly diagnosed with prostate cancer at intermediate or high-risk.&#xD;
&#xD;
      To evaluate association between [68Ga]Ga-PSMA-11 PET/CT uptake value (SUVmax and SUVmean) and&#xD;
      aggressiveness of prostate tumor (e.g. PSA serum level and Gleason Score).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">September 20, 2020</start_date>
  <completion_date type="Anticipated">September 20, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 20, 2024</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 measures (sensitivity, specificity, positive and negative predictive values) of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node, soft tissues spread or bone metastases).</measure>
    <time_frame>Up to 24 months after treatment</time_frame>
    <description>For the primary objective, the following index test and reference test will be considered:&#xD;
Index test: [68Ga]Ga-PSMA-11 PET/CT performed before treatment. Reference test: clinical, radiological and histo-pathologic assessment, when available, at 12 months followup and up to 24 months after treatment.&#xD;
Two nuclear medicine physicians will review the PET images using PET/CT Software Syngo.via.&#xD;
A PET positive finding for pelvic or retroperitoneal lymph nodes or lymph nodes ≥ 8mm is defined with PSMA uptake equal to or above blood pool and lower than liver.&#xD;
A PET positive finding in lymph nodes of other regions is defined with PSMA uptake equal to or above liver and lower than parotid gland. Any uptake equal to or above parotid gland will be considered positive.&#xD;
The readers will be blinded to clinical and pathologic data, except for the knowledge of diagnosis of biopsy proven prostate cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparation diagnostic accuracy of the [68Ga]Ga-PSMA-11 PET/CT versus the conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the prostatic bed and extra prostatic disease.</measure>
    <time_frame>Up to 24 months after treatment</time_frame>
    <description>For the secondary objective, the following index test and reference test will be considered:&#xD;
Index test: conventional imaging mpMRI performed before treatment. Reference test: clinical, radiological and histo-pathologic assessment at 12 months follow-up and up to 24 months after treatment.&#xD;
MRI imaging results will be evaluated by two radiologists specializing in body MRI imaging with the PI-RADS version 2 criteria.&#xD;
In addition, for the secondary objective, after testing the assumption of normality with the Kolmogorov-Smirnov test, the metabolic PET parameters (SUV max and SUV mean) will be correlated with PSA serum level, by using the Pearson correlation, and with Gleason score and tumor volume, by using the Spearman correlation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Prostatic Neoplasm</condition>
  <condition>Urogenital Neoplasms</condition>
  <condition>Prostatic Disease</condition>
  <condition>Disease Attributes</condition>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>[68Ga]Ga-PSMA-11 PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>[68Ga]Ga-PSMA-11 PET/CT</intervention_name>
    <description>1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT</description>
    <arm_group_label>[68Ga]Ga-PSMA-11 PET/CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        I. Patients with histo-pathological confirmation of PCa with intermediate or high-risk&#xD;
        disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see&#xD;
        Study Population paragraph)&#xD;
&#xD;
        II. Patients with conventional imaging mpMRI (with or without CT of the lower abdomen and&#xD;
        Bone scan) performed as baseline in primary PCa staging according to 2019 Prostate Cancer&#xD;
        EAU Guidelines&#xD;
&#xD;
        III. Age &gt;18 years/old&#xD;
&#xD;
        IV. Ability to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        I. Contra-indication for PET/CT scan: Patients not capable of getting PET study due to&#xD;
        weight, claustrophobia, or inability to lay still for the duration of the exam&#xD;
&#xD;
        II. Impaired renal function&#xD;
&#xD;
        III. Impaired liver function: AST or ALT &gt; 2.5 x ULN&#xD;
&#xD;
        IV. Patients unable to understand the purpose of the study&#xD;
&#xD;
        V. Medical history of allergic reactions or hypersensitivity to [68Ga] Ga-PSMA-11 as well&#xD;
        as to any excipient or component of the experimental medicinal product&#xD;
&#xD;
        VI. Having partecipated in clinical trial in which the experimental intervention was&#xD;
        administered within 30 days (or 5 half-life) from administration the endovenous solution of&#xD;
        [68Ga]Ga-PSMA-11&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Pietro Ghedini, MD</last_name>
    <phone>0594225167</phone>
    <email>ghedini.pietro@aou.mo.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Modena</name>
      <address>
        <city>Modena</city>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pietro Ghedini, MD</last_name>
      <phone>0594225167</phone>
      <email>ghedini.pietro@aou.mo.it</email>
    </contact>
    <investigator>
      <last_name>Antonella Franceschetto, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pietro Ghedini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Antonella Iudicello, Pharm D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliero-Universitaria di Modena</investigator_affiliation>
    <investigator_full_name>Antonella Franceschetto</investigator_full_name>
    <investigator_title>Prof</investigator_title>
  </responsible_party>
  <keyword>68GaPSMA PET/CT</keyword>
  <keyword>Prostate cancer</keyword>
  <keyword>primary staging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Urogenital Neoplasms</mesh_term>
    <mesh_term>Prostatic Diseases</mesh_term>
    <mesh_term>Disease Attributes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallium 68 PSMA-11</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided</ipd_description>
  </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/NCT04462926
org study id: ND
secondary id: 2019-004685-18
nct id: NCT04462926
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment
      interventional study.

      Its aim is to evaluate the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in detection of
      primary tumour and extra prostatic disease (lymph node, soft tissues spread or bone
      metastases) in men newly diagnosed with Prostate Cancer at Intermediate and High Risk,
      according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study
      Population paragraph).

      The investigators are interested in the possible future role of [68Ga]Ga-labelled PSMA PET/CT
      as integration to conventional imaging mpMRI (with or without CT of the lower abdomen and
      Bone scan) in the detection of primary tumor and extra-prostatic disease (lymph node and soft
      tissues spread or bone metastases).
This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment
      interventional study.

      The primary objective of this study is to evaluate the diagnostic accuracy of
      [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node,
      soft tissues spread or bone metastases) in men newly diagnosed with prostate cancer at
      intermediate or high-risk.

      The secondary objective of this study is to compare the diagnostic accuracy of
      [68Ga]Ga-PSMA-11 PET/CT to the diagnostic accuracy of conventional imaging mpMRI (with or
      without CT of the lower abdomen and Bone scan) in the prostatic bed and extra prostatic
      disease in men newly diagnosed with prostate cancer at intermediate or high-risk.

      To evaluate association between [68Ga]Ga-PSMA-11 PET/CT uptake value (SUVmax and SUVmean) and
      aggressiveness of prostate tumor (e.g. PSA serum level and Gleason Score).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic accuracy measures (sensitivity, specificity, positive and negative predictive values) of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node, soft tissues spread or bone metastases).
time frame: Up to 24 months after treatment
description: For the primary objective, the following index test and reference test will be considered:
Index test: [68Ga]Ga-PSMA-11 PET/CT performed before treatment. Reference test: clinical, radiological and histo-pathologic assessment, when available, at 12 months followup and up to 24 months after treatment.
Two nuclear medicine physicians will review the PET images using PET/CT Software Syngo.via.
A PET positive finding for pelvic or retroperitoneal lymph nodes or lymph nodes ≥ 8mm is defined with PSMA uptake equal to or above blood pool and lower than liver.
A PET positive finding in lymph nodes of other regions is defined with PSMA uptake equal to or above liver and lower than parotid gland. Any uptake equal to or above parotid gland will be considered positive.
The readers will be blinded to clinical and pathologic data, except for the knowledge of diagnosis of biopsy proven prostate cancer.
measure: Comparation diagnostic accuracy of the [68Ga]Ga-PSMA-11 PET/CT versus the conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the prostatic bed and extra prostatic disease.
time frame: Up to 24 months after treatment
description: For the secondary objective, the following index test and reference test will be considered:
Index test: conventional imaging mpMRI performed before treatment. Reference test: clinical, radiological and histo-pathologic assessment at 12 months follow-up and up to 24 months after treatment.
MRI imaging results will be evaluated by two radiologists specializing in body MRI imaging with the PI-RADS version 2 criteria.
In addition, for the secondary objective, after testing the assumption of normality with the Kolmogorov-Smirnov test, the metabolic PET parameters (SUV max and SUV mean) will be correlated with PSA serum level, by using the Pearson correlation, and with Gleason score and tumor volume, by using the Spearman correlation.
arm group label: [68Ga]Ga-PSMA-11 PET/CT
arm group type: Experimental
description: 1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT
intervention type: Diagnostic Test
intervention name: [68Ga]Ga-PSMA-11 PET/CT
description: 1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT
arm group label: [68Ga]Ga-PSMA-11 PET/CT
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pietro Ghedini, MD
phone: 0594225167
email: ghedini.pietro@aou.mo.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliero-Universitaria di Modena
investigator full name: Antonella Franceschetto
investigator title: Prof
mesh term: Prostatic Neoplasms
mesh term: Neoplasms
mesh term: Urogenital Neoplasms
mesh term: Prostatic Diseases
mesh term: Disease Attributes
mesh term: Gallium 68 PSMA-11
sharing ipd: Undecided
ipd description: Undecided