<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/NCT03232164</url>
  </required_header>
  <id_info>
    <org_study_id>UW16062</org_study_id>
    <secondary_id>2016-0883</secondary_id>
    <secondary_id>A539300</secondary_id>
    <secondary_id>NCI-2017-01643</secondary_id>
    <secondary_id>Protocol Version 3/10/2022</secondary_id>
    <secondary_id>Bluemke Family Trust</secondary_id>
    <nct_id>NCT03232164</nct_id>
  </id_info>
  <brief_title>PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer</brief_title>
  <official_title>PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this research is to validate and develop a non-invasive imaging biomarker&#xD;
      of prostate cancer detection, progression, and recurrence. Development of such a biomarker&#xD;
      may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing&#xD;
      for selection of an appropriate risk adaptive therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose to evaluate a novel second-generation low-molecular-weight prostate&#xD;
      specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL,&#xD;
      for detection of primary and metastatic prostate cancer. 18F-DCFPyL PET demonstrates very&#xD;
      high tumor-to-background and tumor specific uptake which may allow for a more sensitive and&#xD;
      accurate method for detection of early tumor recurrence and metastatic disease as compared to&#xD;
      current PET radiotracers and current standard-of-care imaging including 99mTc-methylene&#xD;
      diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and&#xD;
      magnetic resonance imaging (MRI).&#xD;
&#xD;
      Primary Objectives: The investigators propose to evaluate this PET agent for four different&#xD;
      prostate cancer clinical scenarios.&#xD;
&#xD;
        1. detection of clinically significant high-grade prostate cancer and initial staging&#xD;
&#xD;
        2. detection of sites of recurrence in the setting of biochemical recurrence after&#xD;
           definitive prostatectomy&#xD;
&#xD;
        3. detection of advanced androgen-resistant metastatic prostate cancer, and&#xD;
&#xD;
        4. detection of clinically significant prostate cancer in very low to intermediate risk&#xD;
           primary prostate cancer&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  Evaluate the performance of 18F-DCFPyL PET and MRI whole body DWI for detection of&#xD;
           local-nodal and distant metastatic disease on initial staging compared to conventional&#xD;
           imaging modalities (CT and bone scintigraphy).&#xD;
&#xD;
        -  Correlate 18F-DCFPyL PET standardized-uptake values (SUV) and MRI parameters with PSMA&#xD;
           expression by prostatectomy pathology IHC.&#xD;
&#xD;
        -  Evaluate the specificity of 18F-DCFPyL PET for differentiating primary prostate cancer&#xD;
           versus non-malignant prostate lesions (BPH, prostatitis).&#xD;
&#xD;
        -  Comparison of whole body low-dose CT and whole body MRI derived PET SUV-quantitation.&#xD;
&#xD;
        -  Evaluate the performance of dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET&#xD;
           acquisition and multi-parametric MRI for differentiation of urine versus recurrent&#xD;
           malignancy in the prostatectomy bed.&#xD;
&#xD;
        -  Evaluate the contribution of whole body MRI DWI obtained from PET/MRI to improve the&#xD;
           diagnostic performance of 18F-DCFPyL PET/CT and PET/MRI for metastatic prostate cancer&#xD;
           lesion detection.&#xD;
&#xD;
        -  Assess the quantitative accuracy of PET-derived standardized uptake value (SUV)-based&#xD;
           parameters in 18F-DCFPyL PET obtained from PET/MRI versus PET/CT.&#xD;
&#xD;
        -  Assess the quantitative reproducibility of 18F-DCFPyL PET/CT derived-SUV values in&#xD;
           normal organ and metastatic tumor lesions.&#xD;
&#xD;
        -  Evaluate the ability of 18F-DCFPyL PET to improve detection of clinically significant&#xD;
           primary prostate cancer in men with very low to intermediate risk prostate cancer under&#xD;
           active surveillance or watchful waiting.&#xD;
&#xD;
      Update: As of July 2022 verification, the investigators are no longer enrolling into&#xD;
      sub-studies 1 and 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>Single center, open label, single-arm, pilot study</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>18F-DCFPyL PSMA-based PET and multi-parametric MRI with DWI for Sub-Study 1: Primary Prostate Cancer</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>To evaluate the performance of 18F-DCFPyL PSMA-based PET and multi-parametric MRI (MP-MRI) with DWI (Diffusion Weighted Imaging) and gadolinium DCE (Dynamic Contrast Enhanced) using a dedicated PET/MRI scanner to detect clinically significant larger volume high-grade primary prostate cancer based on prostatectomy step-section pathology correlation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate 18F-DCFPyL PSMA-based PET for localization for Sub-Study 2: Biochemical Recurrence</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>To evaluate the performance of 18F-DCFPyL PSMA-based PET for localization of the site of recurrent prostate cancer in men with biochemical recurrence after definitive prostatectomy with planned salvage external-beam radiation therapy (EBRT). PSA response to prostatic fossa salvage irradiation will be compared with pre-salvage 18F-DCFPyL PET uptake in the radiation field.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare detectability of 18F-DCFPyL for Sub-Study 3: Metastatic Androgen-Resistant Prostate Cancer</measure>
    <time_frame>up to 7 days</time_frame>
    <description>To compare the detectability of metastatic prostate cancer using 18F-DCFPyL PET obtained from PET/CT and PET/MRI compared to conventional imaging modalities (CIM) (bone scan and CT) in men with androgen-resistant prostate cancer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sub-Study 4: Rate of positive cancer detection using PET/MRI directed MRI/transrectal ultrasound (TRUS) fusion biopsy with and without additional PSMA PET information</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>To evaluate the ability of 18F-DCFPyL PSMA PET to improve detection of clinically significant cancer in men with very low to intermediate risk prostate cancer using a dedicated PET/MRI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sub-study 1: Detection of local-nodal and distant metastatic disease (PET</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>Evaluate the performance of 18F-DCFPyL PET and MRI whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-Study 1: Correlation of 18F-DCFPyL PET and MRI</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>Correlate 18F-DCFPyL PET standardized-uptake values (SUV) and MRI parameters with PSMA expression by prostatectomy pathology IHC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-Study 1: Specificity of 18F-DCFPyL</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>Evaluate the specificity of 18F-DCFPyL PET for differentiating primary prostate cancer versus non-malignant prostate lesions (BPH, prostatitis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-Study 1: Low-dose CT versus MRI derived PET SUV</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>Comparison of whole body low-dose CT and whole body MRI derived PET SUV-quantitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-Study 2: Detection of local-nodal and distant metastatic disease (pelvic)</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>Comparison of whole body 18F-DCFPyL PET with pelvic MR-MRI and whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-Study 2: Dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>Evaluate the performance of dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI for differentiation of urine versus recurrent malignancy in the prostatectomy bed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-Study 3: Contribution of whole body MRI DWI</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Evaluate the contribution of whole body MRI DWI obtained from PET/MRI to improve the diagnostic performance of 18F-DCFPyL PET/CT and PET/MRI for metastatic prostate cancer lesion detection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-Study 3: Quantitative accuracy</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Assess the quantitative accuracy of 18F-DCFPyL PET standardized uptake value parameters from PET/MRI versus PET/CT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-Study 3: Quantitative reproducibility</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Assess the quantitative reproducibility of 18F-DCFPyL PET/CT derived-SUV values in normal organ and metastatic tumor lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-study 4: Positive Detection Rate of Prostate Cancer via biopsy on PSMA PET versus mpMRI alone in very low to intermediate risk groups active surveillance and watchful waiting patients</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>Evaluate the positive detection rate of prostate cancer via biopsy on PSMA PET versus mpMRI alone in very low to intermediate risk groups active surveillance and watchful waiting patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-study 4: Detection rate of clinically significant prostate cancer in men with directed MRI/US biopsy</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>To evaluate the ability of PSMA PET alone versus mpMRI alone versus combined PSMA PET with mpMRI to detect clinically significant prostate cancer in men with directed MRI/US biopsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-study 4: Detection Rate of Prostate Cancer vs False Positive Findings via Biopsy</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>Evaluate the rate of detection of prostate cancer and false positive findings via biopsy and available prostatectomy histopathology on PSMA PET/MRI versus mpMRI alone in different prostate anatomic regions (transition, central, peripheral zones) in these risk cohorts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-study 4: Number of Participants who change treatment and surgical management plans after inclusion of PSMA-based PET directed biopsy</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>Assess the change in treatment and surgical management plan before and after inclusion of PSMA-based PET directed biopsy histopathology information and additional pelvic and whole body PET/MRI PET information will be obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-study 4: Correlation of PET and MRI parameters for PET and/or MRI positive lesions to biopsy histopathology, cancer grade group, PSA and other clinical parameters</measure>
    <time_frame>one study visit (up to 3.5 hours)</time_frame>
    <description>Qualitative and quantitative PET and MRI parameters for PET and/or MRI positive lesions will be correlated with biopsy histopathology, cancer grade group, PSA and other clinical parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-study 4: Change in Gleason Score</measure>
    <time_frame>one study visit (up to 3.5 hours), post-prostatectomy (standard of care)</time_frame>
    <description>PET and MRI directed biopsy histopathology prostate Gleason score range will be compared, and evaluated for Gleason score upgrading in any patients who undergo prostatectomy with available prostatectomy histopathology as the reference standard. Gleason scores range from 6-10 with higher numbers indicating higher grade cancer.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Prostate Neoplasm</condition>
  <arm_group>
    <arm_group_label>18F-DCFPyL PET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four separate substudies evaluating 18F-DCFPyL PET imaging of prostate cancer in four prostate cancer clinical scenarios under the following subheadings: (1) primary prostate cancer, (2) biochemical recurrence post-prostatectomy prior to radiation therapy, (3) androgen-resistant metastatic disease and (4) detection of clinically significant prostate cancer in low to intermediate risk primary prostate cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-DCFPyL PET</intervention_name>
    <description>18F-DCFPyL PET demonstrates very high tumor-to-background and tumor specific uptake which may allow for a more sensitive and accurate method for detection of early tumor recurrence and metastatic disease as compared to current PET radiotracers and current standard-of-care imaging including 99mTc-methylene diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI).</description>
    <arm_group_label>18F-DCFPyL PET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prostate cancer pathologically proven by prostate biopsy (newly diagnosed for&#xD;
             Sub-Study 1 and 4)&#xD;
&#xD;
          -  Prostate biopsy histology grade ≥ Gleason 1, 6, 3+4, or 4+3; positive biopsy &gt;2 cores&#xD;
&#xD;
          -  Any PSA permitted&#xD;
&#xD;
          -  Two consecutive rising PSA values (Sub-Study 3 only)&#xD;
&#xD;
          -  Castrate-levels of testosterone - total testosterone &lt; 50 ng/dL (Sub-Study 3 only)&#xD;
&#xD;
          -  Patients considered as candidates for and medically fit to undergo prostatectomy&#xD;
&#xD;
          -  At least 7 days after most recent prostate biopsy&#xD;
&#xD;
          -  Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI,&#xD;
             ultrasound or other PET modalities (Sub-Study 3 only)&#xD;
&#xD;
          -  New diagnosis of prostate cancer undergoing additional biopsy evaluation (Sub--Study 4&#xD;
             only)&#xD;
&#xD;
          -  Karnofsky performance status of at least 70 (Sub-Study 4 only)&#xD;
&#xD;
          -  General health and anatomy suitable to undergo transrectal ultrasound-MRI fusion&#xD;
             biopsy of the identified lesions and standard 12 core sextent biopsy (Sub-Study 4&#xD;
             only)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior pelvic external beam radiation therapy or brachytherapy&#xD;
&#xD;
          -  Chemotherapy for prostate cancer&#xD;
&#xD;
          -  Androgen deprivation therapy for prostate cancer&#xD;
&#xD;
          -  Investigational therapy for prostate cancer (Sub-Study 3 Only)&#xD;
&#xD;
          -  Unable to lie flat during or tolerate PET/CT&#xD;
&#xD;
          -  Prior history of any other malignancy within the last 2 years, other than skin basal&#xD;
             cell or cutaneous superficial squamous cell carcinoma that has not metastasized and&#xD;
             superficial bladder cancer.&#xD;
&#xD;
          -  No prostatectomy scheduled more than 12 hours post imaging (Sub-Study 1 only)&#xD;
&#xD;
          -  Serum creatinine &gt; 2 time the upper limit of normal&#xD;
&#xD;
          -  Total bilirubin &gt; 3 times the upper limit of normal&#xD;
&#xD;
          -  Liver Transaminases &gt; 5 times the upper limit of normal&#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>Steve Y Cho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gemma Gliori</last_name>
    <phone>(608) 262-7269</phone>
    <email>ggliori@uwhealth.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Suzanne Hanson</last_name>
    <phone>(608) 263-7421</phone>
    <email>shanson@uwhealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cancer Connect</last_name>
      <phone>800-622-8922</phone>
      <email>clinicaltrials@cancer.wisc.edu</email>
    </contact>
    <investigator>
      <last_name>Steve Y Cho, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>David F Jarrard, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mark A Ritter, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Glenn Liu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joshua M Lang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Scott B Perlman, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://cancer.wisc.edu/</url>
    <description>University of Wisconsin Carbone Cancer Center</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>Prostate neoplasm</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/NCT03232164
org study id: UW16062
secondary id: 2016-0883
secondary id: A539300
secondary id: NCI-2017-01643
secondary id: Protocol Version 3/10/2022
secondary id: Bluemke Family Trust
nct id: NCT03232164
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The overall goal of this research is to validate and develop a non-invasive imaging biomarker
      of prostate cancer detection, progression, and recurrence. Development of such a biomarker
      may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing
      for selection of an appropriate risk adaptive therapy.
The investigators propose to evaluate a novel second-generation low-molecular-weight prostate
      specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL,
      for detection of primary and metastatic prostate cancer. 18F-DCFPyL PET demonstrates very
      high tumor-to-background and tumor specific uptake which may allow for a more sensitive and
      accurate method for detection of early tumor recurrence and metastatic disease as compared to
      current PET radiotracers and current standard-of-care imaging including 99mTc-methylene
      diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and
      magnetic resonance imaging (MRI).

      Primary Objectives: The investigators propose to evaluate this PET agent for four different
      prostate cancer clinical scenarios.

        1. detection of clinically significant high-grade prostate cancer and initial staging

        2. detection of sites of recurrence in the setting of biochemical recurrence after
           definitive prostatectomy

        3. detection of advanced androgen-resistant metastatic prostate cancer, and

        4. detection of clinically significant prostate cancer in very low to intermediate risk
           primary prostate cancer

      Secondary Objectives:

        -  Evaluate the performance of 18F-DCFPyL PET and MRI whole body DWI for detection of
           local-nodal and distant metastatic disease on initial staging compared to conventional
           imaging modalities (CT and bone scintigraphy).

        -  Correlate 18F-DCFPyL PET standardized-uptake values (SUV) and MRI parameters with PSMA
           expression by prostatectomy pathology IHC.

        -  Evaluate the specificity of 18F-DCFPyL PET for differentiating primary prostate cancer
           versus non-malignant prostate lesions (BPH, prostatitis).

        -  Comparison of whole body low-dose CT and whole body MRI derived PET SUV-quantitation.

        -  Evaluate the performance of dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET
           acquisition and multi-parametric MRI for differentiation of urine versus recurrent
           malignancy in the prostatectomy bed.

        -  Evaluate the contribution of whole body MRI DWI obtained from PET/MRI to improve the
           diagnostic performance of 18F-DCFPyL PET/CT and PET/MRI for metastatic prostate cancer
           lesion detection.

        -  Assess the quantitative accuracy of PET-derived standardized uptake value (SUV)-based
           parameters in 18F-DCFPyL PET obtained from PET/MRI versus PET/CT.

        -  Assess the quantitative reproducibility of 18F-DCFPyL PET/CT derived-SUV values in
           normal organ and metastatic tumor lesions.

        -  Evaluate the ability of 18F-DCFPyL PET to improve detection of clinically significant
           primary prostate cancer in men with very low to intermediate risk prostate cancer under
           active surveillance or watchful waiting.

      Update: As of July 2022 verification, the investigators are no longer enrolling into
      sub-studies 1 and 2.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single center, open label, single-arm, pilot study
primary purpose: Diagnostic
masking: None (Open Label)
measure: 18F-DCFPyL PSMA-based PET and multi-parametric MRI with DWI for Sub-Study 1: Primary Prostate Cancer
time frame: one study visit (up to 3.5 hours)
description: To evaluate the performance of 18F-DCFPyL PSMA-based PET and multi-parametric MRI (MP-MRI) with DWI (Diffusion Weighted Imaging) and gadolinium DCE (Dynamic Contrast Enhanced) using a dedicated PET/MRI scanner to detect clinically significant larger volume high-grade primary prostate cancer based on prostatectomy step-section pathology correlation.
measure: Evaluate 18F-DCFPyL PSMA-based PET for localization for Sub-Study 2: Biochemical Recurrence
time frame: one study visit (up to 3.5 hours)
description: To evaluate the performance of 18F-DCFPyL PSMA-based PET for localization of the site of recurrent prostate cancer in men with biochemical recurrence after definitive prostatectomy with planned salvage external-beam radiation therapy (EBRT). PSA response to prostatic fossa salvage irradiation will be compared with pre-salvage 18F-DCFPyL PET uptake in the radiation field.
measure: Compare detectability of 18F-DCFPyL for Sub-Study 3: Metastatic Androgen-Resistant Prostate Cancer
time frame: up to 7 days
description: To compare the detectability of metastatic prostate cancer using 18F-DCFPyL PET obtained from PET/CT and PET/MRI compared to conventional imaging modalities (CIM) (bone scan and CT) in men with androgen-resistant prostate cancer.
measure: Sub-Study 4: Rate of positive cancer detection using PET/MRI directed MRI/transrectal ultrasound (TRUS) fusion biopsy with and without additional PSMA PET information
time frame: one study visit (up to 3.5 hours)
description: To evaluate the ability of 18F-DCFPyL PSMA PET to improve detection of clinically significant cancer in men with very low to intermediate risk prostate cancer using a dedicated PET/MRI.
measure: Sub-study 1: Detection of local-nodal and distant metastatic disease (PET
time frame: one study visit (up to 3.5 hours)
description: Evaluate the performance of 18F-DCFPyL PET and MRI whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy).
measure: Sub-Study 1: Correlation of 18F-DCFPyL PET and MRI
time frame: one study visit (up to 3.5 hours)
description: Correlate 18F-DCFPyL PET standardized-uptake values (SUV) and MRI parameters with PSMA expression by prostatectomy pathology IHC.
measure: Sub-Study 1: Specificity of 18F-DCFPyL
time frame: one study visit (up to 3.5 hours)
description: Evaluate the specificity of 18F-DCFPyL PET for differentiating primary prostate cancer versus non-malignant prostate lesions (BPH, prostatitis).
measure: Sub-Study 1: Low-dose CT versus MRI derived PET SUV
time frame: one study visit (up to 3.5 hours)
description: Comparison of whole body low-dose CT and whole body MRI derived PET SUV-quantitation.
measure: Sub-Study 2: Detection of local-nodal and distant metastatic disease (pelvic)
time frame: one study visit (up to 3.5 hours)
description: Comparison of whole body 18F-DCFPyL PET with pelvic MR-MRI and whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy).
measure: Sub-Study 2: Dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI
time frame: one study visit (up to 3.5 hours)
description: Evaluate the performance of dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI for differentiation of urine versus recurrent malignancy in the prostatectomy bed.
measure: Sub-Study 3: Contribution of whole body MRI DWI
time frame: Up to 7 days
description: Evaluate the contribution of whole body MRI DWI obtained from PET/MRI to improve the diagnostic performance of 18F-DCFPyL PET/CT and PET/MRI for metastatic prostate cancer lesion detection.
measure: Sub-Study 3: Quantitative accuracy
time frame: Up to 7 days
description: Assess the quantitative accuracy of 18F-DCFPyL PET standardized uptake value parameters from PET/MRI versus PET/CT.
measure: Sub-Study 3: Quantitative reproducibility
time frame: Up to 7 days
description: Assess the quantitative reproducibility of 18F-DCFPyL PET/CT derived-SUV values in normal organ and metastatic tumor lesions.
measure: Sub-study 4: Positive Detection Rate of Prostate Cancer via biopsy on PSMA PET versus mpMRI alone in very low to intermediate risk groups active surveillance and watchful waiting patients
time frame: one study visit (up to 3.5 hours)
description: Evaluate the positive detection rate of prostate cancer via biopsy on PSMA PET versus mpMRI alone in very low to intermediate risk groups active surveillance and watchful waiting patients.
measure: Sub-study 4: Detection rate of clinically significant prostate cancer in men with directed MRI/US biopsy
time frame: one study visit (up to 3.5 hours)
description: To evaluate the ability of PSMA PET alone versus mpMRI alone versus combined PSMA PET with mpMRI to detect clinically significant prostate cancer in men with directed MRI/US biopsy.
measure: Sub-study 4: Detection Rate of Prostate Cancer vs False Positive Findings via Biopsy
time frame: one study visit (up to 3.5 hours)
description: Evaluate the rate of detection of prostate cancer and false positive findings via biopsy and available prostatectomy histopathology on PSMA PET/MRI versus mpMRI alone in different prostate anatomic regions (transition, central, peripheral zones) in these risk cohorts.
measure: Sub-study 4: Number of Participants who change treatment and surgical management plans after inclusion of PSMA-based PET directed biopsy
time frame: one study visit (up to 3.5 hours)
description: Assess the change in treatment and surgical management plan before and after inclusion of PSMA-based PET directed biopsy histopathology information and additional pelvic and whole body PET/MRI PET information will be obtained.
measure: Sub-study 4: Correlation of PET and MRI parameters for PET and/or MRI positive lesions to biopsy histopathology, cancer grade group, PSA and other clinical parameters
time frame: one study visit (up to 3.5 hours)
description: Qualitative and quantitative PET and MRI parameters for PET and/or MRI positive lesions will be correlated with biopsy histopathology, cancer grade group, PSA and other clinical parameters.
measure: Sub-study 4: Change in Gleason Score
time frame: one study visit (up to 3.5 hours), post-prostatectomy (standard of care)
description: PET and MRI directed biopsy histopathology prostate Gleason score range will be compared, and evaluated for Gleason score upgrading in any patients who undergo prostatectomy with available prostatectomy histopathology as the reference standard. Gleason scores range from 6-10 with higher numbers indicating higher grade cancer.
arm group label: 18F-DCFPyL PET
arm group type: Experimental
description: Four separate substudies evaluating 18F-DCFPyL PET imaging of prostate cancer in four prostate cancer clinical scenarios under the following subheadings: (1) primary prostate cancer, (2) biochemical recurrence post-prostatectomy prior to radiation therapy, (3) androgen-resistant metastatic disease and (4) detection of clinically significant prostate cancer in low to intermediate risk primary prostate cancer
intervention type: Drug
intervention name: 18F-DCFPyL PET
description: 18F-DCFPyL PET demonstrates very high tumor-to-background and tumor specific uptake which may allow for a more sensitive and accurate method for detection of early tumor recurrence and metastatic disease as compared to current PET radiotracers and current standard-of-care imaging including 99mTc-methylene diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI).
arm group label: 18F-DCFPyL PET
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steve Y Cho, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Gemma Gliori
phone: (608) 262-7269
email: ggliori@uwhealth.org
last name: Suzanne Hanson
phone: (608) 263-7421
email: shanson@uwhealth.org
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
url: https://cancer.wisc.edu/
description: University of Wisconsin Carbone Cancer Center
responsible party type: Sponsor
mesh term: Prostatic Neoplasms