<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/NCT04461509</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000832</org_study_id>
    <nct_id>NCT04461509</nct_id>
  </id_info>
  <brief_title>High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy</brief_title>
  <official_title>High-Resolution, 18F-PSMA PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy or Radical Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alessandro D'Agnolo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Progenics Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective trial aims to determine if enhanced prostate imaging using two novel imaging&#xD;
      technologies (high resolution DWI and 18F-PSMA PET-MRI) will detect prostate cancers not seen&#xD;
      on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective trial to evaluate the effectiveness of 18F-PSMA PET-hrMRI versus&#xD;
      standard mpMRI at identifying prostate cancer targets for HIFU therapy.&#xD;
&#xD;
      Participants with clinically localized, unilateral high grade prostate cancer (Gleason score&#xD;
      7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having&#xD;
      unrecognized high grade prostate cancer (overall Gleason score 6 with &gt; half of systematic&#xD;
      biopsy cores positive and &gt; 50% of core involvement in at least one core), interested in HIFU&#xD;
      would receive both a standard mpMRI and 18F-PSMA PET-hrMRI.&#xD;
&#xD;
      Participants would then undergo a mapping biopsy using a standard sextant template plus&#xD;
      MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 6, 2021</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>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>Patients are identified by investigator and enrolled in Arm 1 (HIFU) or Arm 2 (RP)</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Endpoint (HIFU):</measure>
    <time_frame>At time of post-imaging biopsy, 6 months following standard HIFU therapy</time_frame>
    <description>Number of additional biopsy-proven cancers that novel imaging modalities of hrMRI and/or F18-PSMA PET would detect when compared to reference standard imaging of mpMRI in patients undergoing HIFU procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Endpoint (Prostatectomy):</measure>
    <time_frame>preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery</time_frame>
    <description>To determine the sensitivity in detection of prostatic carcinoma of novel imaging modalities of hrMRI and/or F18-PSMA PET compared to reference standard mpMRI in patients scheduled to undergo radical prostatectomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Endpoint (HIFU):</measure>
    <time_frame>6 months following standard HIFU therapy</time_frame>
    <description>Negative biopsy rate on standard 12-core biopsy 6 months following HIFU therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Endpoint (Prostatectomy):</measure>
    <time_frame>6 months following standard HIFU therapy</time_frame>
    <description>Specificity of hrMRI, F18-PSMA PET and mpMRI for detecting all tumors and metastasis at 6 months follow up.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory Endpoint:</measure>
    <time_frame>After study completion, an average of 6 months</time_frame>
    <description>RNAseq transcriptome analysis of lesions that are positive on mapping biopsy. Sensitivity and specificity of PET-hrMRI for detecting all tumors detected on prostatectomy pathology.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">61</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <condition>Genital Neoplasms, Male</condition>
  <condition>Urogenital Neoplasms</condition>
  <condition>Neoplasms by Site</condition>
  <condition>Neoplasms</condition>
  <condition>Genital Diseases, Male</condition>
  <condition>Prostatic Disease</condition>
  <arm_group>
    <arm_group_label>ARM 1 (HIFU) - 18F-PSMA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mCi ±20% F18-PSMA injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM 2 (RP) - 18F-PSMA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mCi ±20% F18-PSMA injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-PSMA</intervention_name>
    <description>Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-PSMA)&#xD;
Other Names:&#xD;
18F-DCFPyL Injection prostate-cancer-specific radiotracer</description>
    <arm_group_label>ARM 1 (HIFU) - 18F-PSMA</arm_group_label>
    <arm_group_label>ARM 2 (RP) - 18F-PSMA</arm_group_label>
    <other_name>18F-DCFPyL Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Biopsy consisting of ≥ 10 tissue cores sampled&#xD;
&#xD;
          2. PSA &lt;20 ng/mL (for HIFU arm only)&#xD;
&#xD;
          3. cT1-cT2c&#xD;
&#xD;
          4. Either overall Gleason score &gt; 7 with Gleason grade 4 or 5 component localized to one&#xD;
             lobe (i.e. right or left) OR overall Gleason score 6 with &gt; half of systematic biopsy&#xD;
             cores positive and &gt; 50% of core involvement in at least one core (for HIFU arm only)&#xD;
&#xD;
          5. Patient considering focal HIFU therapy or robotic radical prostatectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous local therapy for prostate cancer&#xD;
&#xD;
          2. Inability to receive PET tracer&#xD;
&#xD;
          3. Inability to receive MRI&#xD;
&#xD;
          4. Estimated glomerular filtration rate (GFR) &lt;15 mL/min/1.73 m2&#xD;
&#xD;
          5. Any other condition which, in the investigator's option, may make the patient a poor&#xD;
             candidate for participation in a clinical trial.&#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_official>
    <last_name>Alessandro D'Agnolo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jenny Park, MPH</last_name>
    <phone>310-423-8762</phone>
    <email>Jenny.park@cshs.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laura Sarmiento</last_name>
    <phone>310-423-4295</phone>
    <email>Laura.sarmiento@cshs.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alessandro D'Agnolo, MD</last_name>
      <phone>310-423-4682</phone>
      <email>Alessandro.Dagnolo@cshs.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 3, 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>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Alessandro D'Agnolo</investigator_full_name>
    <investigator_title>Co-Director Nuclear Medicine</investigator_title>
  </responsible_party>
  <keyword>Diagnostic imaging</keyword>
  <keyword>High-Intensity Focused Ultrasound</keyword>
  <keyword>HIFU</keyword>
  <keyword>18F-PSMA</keyword>
  <keyword>high resolution diffusion-weighted imaging</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>Neoplasms by Site</mesh_term>
    <mesh_term>Urogenital Neoplasms</mesh_term>
    <mesh_term>Genital Neoplasms, Male</mesh_term>
    <mesh_term>Genital Diseases</mesh_term>
    <mesh_term>Prostatic Diseases</mesh_term>
    <mesh_term>Genital Diseases, Male</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/NCT04461509
org study id: STUDY00000832
nct id: NCT04461509
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This prospective trial aims to determine if enhanced prostate imaging using two novel imaging
      technologies (high resolution DWI and 18F-PSMA PET-MRI) will detect prostate cancers not seen
      on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.
This is a prospective trial to evaluate the effectiveness of 18F-PSMA PET-hrMRI versus
      standard mpMRI at identifying prostate cancer targets for HIFU therapy.

      Participants with clinically localized, unilateral high grade prostate cancer (Gleason score
      7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having
      unrecognized high grade prostate cancer (overall Gleason score 6 with > half of systematic
      biopsy cores positive and > 50% of core involvement in at least one core), interested in HIFU
      would receive both a standard mpMRI and 18F-PSMA PET-hrMRI.

      Participants would then undergo a mapping biopsy using a standard sextant template plus
      MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Patients are identified by investigator and enrolled in Arm 1 (HIFU) or Arm 2 (RP)
primary purpose: Other
masking: None (Open Label)
measure: Primary Endpoint (HIFU):
time frame: At time of post-imaging biopsy, 6 months following standard HIFU therapy
description: Number of additional biopsy-proven cancers that novel imaging modalities of hrMRI and/or F18-PSMA PET would detect when compared to reference standard imaging of mpMRI in patients undergoing HIFU procedure.
measure: Primary Endpoint (Prostatectomy):
time frame: preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery
description: To determine the sensitivity in detection of prostatic carcinoma of novel imaging modalities of hrMRI and/or F18-PSMA PET compared to reference standard mpMRI in patients scheduled to undergo radical prostatectomy.
measure: Secondary Endpoint (HIFU):
time frame: 6 months following standard HIFU therapy
description: Negative biopsy rate on standard 12-core biopsy 6 months following HIFU therapy.
measure: Secondary Endpoint (Prostatectomy):
time frame: 6 months following standard HIFU therapy
description: Specificity of hrMRI, F18-PSMA PET and mpMRI for detecting all tumors and metastasis at 6 months follow up.
measure: Exploratory Endpoint:
time frame: After study completion, an average of 6 months
description: RNAseq transcriptome analysis of lesions that are positive on mapping biopsy. Sensitivity and specificity of PET-hrMRI for detecting all tumors detected on prostatectomy pathology.
arm group label: ARM 1 (HIFU) - 18F-PSMA
arm group type: Experimental
description: 10 mCi ±20% F18-PSMA injection
arm group label: ARM 2 (RP) - 18F-PSMA
arm group type: Experimental
description: 10 mCi ±20% F18-PSMA injection
intervention type: Drug
intervention name: 18F-PSMA
description: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-PSMA)
Other Names:
18F-DCFPyL Injection prostate-cancer-specific radiotracer
arm group label: ARM 1 (HIFU) - 18F-PSMA
arm group label: ARM 2 (RP) - 18F-PSMA
other name: 18F-DCFPyL Injection
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alessandro D'Agnolo, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Jenny Park, MPH
phone: 310-423-8762
email: Jenny.park@cshs.org
last name: Laura Sarmiento
phone: 310-423-4295
email: Laura.sarmiento@cshs.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Alessandro D'Agnolo
investigator title: Co-Director Nuclear Medicine
mesh term: Prostatic Neoplasms
mesh term: Neoplasms
mesh term: Neoplasms by Site
mesh term: Urogenital Neoplasms
mesh term: Genital Neoplasms, Male
mesh term: Genital Diseases
mesh term: Prostatic Diseases
mesh term: Genital Diseases, Male
sharing ipd: Undecided