<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/NCT04484701</url>
  </required_header>
  <id_info>
    <org_study_id>H20-01325</org_study_id>
    <nct_id>NCT04484701</nct_id>
  </id_info>
  <brief_title>[68Ga]Ga-PSMA-11 PET/CT in the Assessment of High Risk and Recurrent Prostate Cancer</brief_title>
  <official_title>68Ga-PSMA-11 Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of High Risk or Recurrent Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>British Columbia Cancer Agency</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>British Columbia Cancer Agency</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prostate cancer is the third most common cause of cancer death in men. Most patients with&#xD;
      localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of&#xD;
      patients will have their prostate cancer return. Whether it has returned locally or distantly&#xD;
      determines which type of treatment they will receive. Current conventional imaging modalities&#xD;
      have limitations particularly at low prostate specific antigen levels. This study proposes to&#xD;
      use Gallium-68-PSMA-11 (68Ga-PSMA-11) Positron Emission Tomography / Computer Tomography&#xD;
      (PET/CT) scans which targets prostate-specific membrane antigens (PSMA) to detect where in&#xD;
      the body the prostate cancer has recurred.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective registry study to evaluate the diagnostic utility of 68Ga-PSMA-11&#xD;
      PET/CT to stage patients with high risk prostate cancer, localize sites of biochemical&#xD;
      recurrence of prostate cancer, and restage patients with advanced prostate cancer before and&#xD;
      after onset of new therapy.&#xD;
&#xD;
      Eligible subjects will undergo a 68Ga-PSMA-11 PET/CT at the British Columbia Cancer (BCC) -&#xD;
      Vancouver. Each subject will receive a 68Ga-PSMA-11 PET/CT scan at the BCC - Vancouver, as&#xD;
      part of this research study. Each study subject will receive a bolus intravenous dose of&#xD;
      68Ga-PSMA-11. The subject will rest in a comfortable chair for 60 minutes and will then be&#xD;
      taken to the PET/CT scanner for images. The PET/CT scan will take approximately 2.5 hours of&#xD;
      patient time above and beyond the time needed for standard of care.&#xD;
&#xD;
      Medical History Questionnaire: Demographic and medical history data will be collected either&#xD;
      in person before the PET scan appointment or by mail or phone, whichever is the most&#xD;
      convenient to the subject.&#xD;
&#xD;
      Follow-up assessments: All subjects will be contacted by phone the day after the injection of&#xD;
      68Ga-PSMA-11. The subjects will be asked if they experienced any undesirable effects during&#xD;
      the 12 hours after the administration of 68Ga-PSMA-11. The local site attending nuclear&#xD;
      medicine physician will then make an assessment as to whether these effects are likely&#xD;
      related to 68Ga-PSMA-11 administration.&#xD;
&#xD;
      All subjects will be followed for 5 years following the 68Ga-PSMA-11 PET/CT exam to assess&#xD;
      the presence of recurrence. The evaluation will include a chart review of available imaging,&#xD;
      laboratory tests, and treatment. The data required can be obtained from a review of the&#xD;
      patient's paper and electronic charts, supplemented by telephone contact as needed to&#xD;
      complete the information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">September 2028</completion_date>
  <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Sensitivity of 68Ga-PSMA-11 PET/CT imaging in the assessment of high risk and recurrent prostate cancer.</measure>
    <time_frame>5 years after PSMA-11 PET/CT scan</time_frame>
    <description>Determination of sensitivity when compared with pathology reports (if available) and routine imaging (CT, MRI, bone scan) if available.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predictive value of 68Ga-PSMA-11 PET/CT imaging</measure>
    <time_frame>5 years after the PSMA PET scan</time_frame>
    <description>The clinical predictive value will be assessed by multivariate analysis, using a Cox proportional hazard model, including established clinical parameters at initial presentation or relapse for the 5 most active lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of 68Ga-PSMA-11 PET/CT imaging</measure>
    <time_frame>5 years after the PSMA PET scan</time_frame>
    <description>The accuracy (along with the confidence interval) of 68Ga-PSMA-11 will be calculated for subjects with an available gold standard.&#xD;
The gold standard for the detection of lesions will be established through a combination of: 1) pathology results following surgical resection; 2) disease progression of specific 68Ga-PSMA-11 findings on clinical or conventional imaging follow-up; 3) unequivocal disease response of specific 68Ga-PSMA-11 findings on conventional imaging follow-up after treatment; 4) decrease of PSA level after targeted radiation of 68Ga-PSMA-11 findings; 5) progression of 68Ga-PSMA-11 findings on subsequent 68Ga-PSMA-11 imaging associated with a concurrent increase in PSA level; 6) regression of [68Ga]Ga-PSMA-11 findings on subsequent [68Ga]Ga-PSMA-11 imaging associated with a concurrent decrease in PSA level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of 68Ga-PSMA-11 PET/CT imaging</measure>
    <time_frame>5 years after the PSMA PET scan</time_frame>
    <description>The specificity (along with the confidence interval) of [68Ga]Ga-PSMA-11 will be calculated for subjects with an available gold standard (see above for definition).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with self-reported 68Ga-PSMA-11-related adverse event</measure>
    <time_frame>12 hours post 68Ga-PSMA-11 injection</time_frame>
    <description>Patients will be contacted by phone the day after the 68Ga-PSMA-11 PET/CT scan to see if they experienced any adverse events in the 12 hours following the 68Ga-PSMA-11 injection. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1574</enrollment>
  <condition>Prostatic Neoplasm</condition>
  <condition>Prostatic Cancer</condition>
  <arm_group>
    <arm_group_label>PSMA-11 PET/CT scan</arm_group_label>
    <description>All participants will undergo the same procedures listed in &quot;Detailed Description&quot; in the protocol section.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>68Ga-PSMA-11</intervention_name>
    <description>PET/CT scan with radiotracer 68Ga-PSMA-11</description>
    <arm_group_label>PSMA-11 PET/CT scan</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with high risk prostate cancer at initial presentation (CAPRA score 6 or higher),&#xD;
        subjects with biochemical persistence of prostate cancer following radical prostatectomy,&#xD;
        subjects with biochemical recurrence of prostate cancer following initial curative&#xD;
        treatment with radical prostatectomy or radiation therapy, subjects with biochemical&#xD;
        recurrence of prostate cancer following radical prostatectomy who received subsequent&#xD;
        salvage radiotherapy, and subjects with advanced prostate cancer (castration sensitive or&#xD;
        castration resistant disease that is metastatic with conventional imaging, castration&#xD;
        resistant disease that is non-metastatic on conventional imaging).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status of 2 or less.&#xD;
&#xD;
          -  Subjects with high risk prostate cancer (CAPRA score 6 or higher) being considered for&#xD;
             curative-intent surgery or radiation therapy (including brachytherapy)&#xD;
&#xD;
          -  Subjects with biopsy confirmed prostate cancer being considered for curative-intent&#xD;
             surgery or radiation therapy (including brachytherapy), who have unconfirmed&#xD;
             suspicious findings on conventional medical imaging staging examinations.&#xD;
&#xD;
          -  Subjects with biochemical recurrence or persistence of prostate cancer following&#xD;
             initial curative treatment by radical prostatectomy, with two consecutive PSA values&#xD;
             &gt;0.2 ng/ml measured more than 6 weeks after radical prostatectomy. If subjects&#xD;
             received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT&#xD;
             imaging must be greater than 0.2 ng/mL.&#xD;
&#xD;
          -  Subjects with biochemical recurrence or persistence of prostate cancer following&#xD;
             initial curative treatment by radical prostatectomy and subsequently treated by&#xD;
             salvage radiotherapy or pelvic node dissection, with two consecutive PSA values &gt;0.2&#xD;
             ng/ml. If subjects received subsequent systemic therapy, the most recent PSA&#xD;
             measurement prior to PET/CT imaging must be greater than 0.2 ng/mL.&#xD;
&#xD;
          -  Subjects with biochemical recurrence of prostate cancer after initial curative therapy&#xD;
             with radiation therapy (including brachytherapy), or non-standard local ablative&#xD;
             therapy (such as high frequency ultrasound, cryoablation, focal laser ablation, etc.),&#xD;
             with a PSA level &gt;2 ng/mL above the nadir after radiation therapy.&#xD;
&#xD;
          -  Subjects with advanced castration sensitive or castration resistant prostate cancer&#xD;
             being considered for localized treatment (surgery, brachytherapy, radiotherapy) of&#xD;
             recurrent or oligometastatic prostate cancer. Castration resistance is defined as a&#xD;
             PSA level &gt; 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of&#xD;
             castrate levels of testosterone (&lt; 1.7 nmol/L).&#xD;
&#xD;
          -  Subjects with metastatic or castration resistant prostate cancer being evaluated for&#xD;
             systemic therapy administered in therapeutic clinical trials. The PSA level must be &gt;&#xD;
             1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate&#xD;
             levels of testosterone (&lt; 1.7 nmol/L).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically unstable (e.g. acute illness, unstable vital signs)&#xD;
&#xD;
          -  Unable to lie supine for the duration of imaging&#xD;
&#xD;
          -  Unable to provide written consent&#xD;
&#xD;
          -  Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the&#xD;
             PET/CT bore (diameter 70 cm)&#xD;
&#xD;
        Exclusion criteria for the use of furosemide Subjects can still participate in the research&#xD;
        study and undergo the [68Ga]Ga-PSMA-11 scan if they are unable or unwilling to receive a&#xD;
        furosemide injection.&#xD;
&#xD;
          -  Subjects with end stage renal disease.&#xD;
&#xD;
          -  Subjects with documented history of severe progressive chronic kidney disease&#xD;
             (glomerular filtration rate less than 30 mL/min/1.73 m2).&#xD;
&#xD;
          -  Subjects with hypersensitivity to furosemide (Lasix).&#xD;
&#xD;
          -  While cross-reactivity between sulfonamide antibiotics and non-antibiotics has been&#xD;
             disproven, subjects who have a history of sulfonamide antibiotics or sulfonylureas may&#xD;
             be at a higher risk of allergic reaction to furosemide due to a higher general&#xD;
             predisposition to allergic reactions. In those instances, the administration of&#xD;
             furosemide is left at the discretion of the local site investigator after discussion&#xD;
             with the study subject.&#xD;
&#xD;
          -  Subjects with severe hypokalemia, hyponatremia, hypovolemia, dehydration or&#xD;
             hypotension.&#xD;
&#xD;
          -  Subjects with untreated bladder outlet obstruction or lower urinary tract symptoms,&#xD;
             who have a history of obstructive episodes that required hospitalization, emergency&#xD;
             department visits and/or bladder catheterization for relief of symptoms.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francois Benard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BC Cancer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heather Saprunoff</last_name>
    <phone>604-877-6000</phone>
    <phone_ext>2818</phone_ext>
    <email>hsaprunoff@bccancer.bc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>BC Cancer</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Saprunoff</last_name>
      <phone>604-877-6000</phone>
      <phone_ext>2818</phone_ext>
      <email>hsaprunoff@bccancer.bc.ca</email>
    </contact>
    <investigator>
      <last_name>Francois Benard, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</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 Neoplasms</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>No</sharing_ipd>
    <ipd_description>No plan.</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/NCT04484701
org study id: H20-01325
nct id: NCT04484701
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prostate cancer is the third most common cause of cancer death in men. Most patients with
      localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of
      patients will have their prostate cancer return. Whether it has returned locally or distantly
      determines which type of treatment they will receive. Current conventional imaging modalities
      have limitations particularly at low prostate specific antigen levels. This study proposes to
      use Gallium-68-PSMA-11 (68Ga-PSMA-11) Positron Emission Tomography / Computer Tomography
      (PET/CT) scans which targets prostate-specific membrane antigens (PSMA) to detect where in
      the body the prostate cancer has recurred.
This is a prospective registry study to evaluate the diagnostic utility of 68Ga-PSMA-11
      PET/CT to stage patients with high risk prostate cancer, localize sites of biochemical
      recurrence of prostate cancer, and restage patients with advanced prostate cancer before and
      after onset of new therapy.

      Eligible subjects will undergo a 68Ga-PSMA-11 PET/CT at the British Columbia Cancer (BCC) -
      Vancouver. Each subject will receive a 68Ga-PSMA-11 PET/CT scan at the BCC - Vancouver, as
      part of this research study. Each study subject will receive a bolus intravenous dose of
      68Ga-PSMA-11. The subject will rest in a comfortable chair for 60 minutes and will then be
      taken to the PET/CT scanner for images. The PET/CT scan will take approximately 2.5 hours of
      patient time above and beyond the time needed for standard of care.

      Medical History Questionnaire: Demographic and medical history data will be collected either
      in person before the PET scan appointment or by mail or phone, whichever is the most
      convenient to the subject.

      Follow-up assessments: All subjects will be contacted by phone the day after the injection of
      68Ga-PSMA-11. The subjects will be asked if they experienced any undesirable effects during
      the 12 hours after the administration of 68Ga-PSMA-11. The local site attending nuclear
      medicine physician will then make an assessment as to whether these effects are likely
      related to 68Ga-PSMA-11 administration.

      All subjects will be followed for 5 years following the 68Ga-PSMA-11 PET/CT exam to assess
      the presence of recurrence. The evaluation will include a chart review of available imaging,
      laboratory tests, and treatment. The data required can be obtained from a review of the
      patient's paper and electronic charts, supplemented by telephone contact as needed to
      complete the information.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity of 68Ga-PSMA-11 PET/CT imaging in the assessment of high risk and recurrent prostate cancer.
time frame: 5 years after PSMA-11 PET/CT scan
description: Determination of sensitivity when compared with pathology reports (if available) and routine imaging (CT, MRI, bone scan) if available.
measure: Predictive value of 68Ga-PSMA-11 PET/CT imaging
time frame: 5 years after the PSMA PET scan
description: The clinical predictive value will be assessed by multivariate analysis, using a Cox proportional hazard model, including established clinical parameters at initial presentation or relapse for the 5 most active lesions.
measure: Accuracy of 68Ga-PSMA-11 PET/CT imaging
time frame: 5 years after the PSMA PET scan
description: The accuracy (along with the confidence interval) of 68Ga-PSMA-11 will be calculated for subjects with an available gold standard.
The gold standard for the detection of lesions will be established through a combination of: 1) pathology results following surgical resection; 2) disease progression of specific 68Ga-PSMA-11 findings on clinical or conventional imaging follow-up; 3) unequivocal disease response of specific 68Ga-PSMA-11 findings on conventional imaging follow-up after treatment; 4) decrease of PSA level after targeted radiation of 68Ga-PSMA-11 findings; 5) progression of 68Ga-PSMA-11 findings on subsequent 68Ga-PSMA-11 imaging associated with a concurrent increase in PSA level; 6) regression of [68Ga]Ga-PSMA-11 findings on subsequent [68Ga]Ga-PSMA-11 imaging associated with a concurrent decrease in PSA level.
measure: Specificity of 68Ga-PSMA-11 PET/CT imaging
time frame: 5 years after the PSMA PET scan
description: The specificity (along with the confidence interval) of [68Ga]Ga-PSMA-11 will be calculated for subjects with an available gold standard (see above for definition).
measure: Number of participants with self-reported 68Ga-PSMA-11-related adverse event
time frame: 12 hours post 68Ga-PSMA-11 injection
description: Patients will be contacted by phone the day after the 68Ga-PSMA-11 PET/CT scan to see if they experienced any adverse events in the 12 hours following the 68Ga-PSMA-11 injection. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report.
arm group label: PSMA-11 PET/CT scan
description: All participants will undergo the same procedures listed in "Detailed Description" in the protocol section.
intervention type: Drug
intervention name: 68Ga-PSMA-11
description: PET/CT scan with radiotracer 68Ga-PSMA-11
arm group label: PSMA-11 PET/CT scan
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 99 Years
healthy volunteers: No
last name: Francois Benard, MD
role: Principal Investigator
affiliation: BC Cancer
last name: Heather Saprunoff
phone: 604-877-6000
phone ext: 2818
email: hsaprunoff@bccancer.bc.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Gallium 68 PSMA-11
sharing ipd: No
ipd description: No plan.