<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/NCT03234556</url>
  </required_header>
  <id_info>
    <org_study_id>4P-16-7</org_study_id>
    <secondary_id>NCI-2017-00890</secondary_id>
    <secondary_id>4P-16-7</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <secondary_id>R01CA205058</secondary_id>
    <nct_id>NCT03234556</nct_id>
  </id_info>
  <brief_title>Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA</brief_title>
  <official_title>Diagnosing Clinically Significant Prostate Cancer in African American and White Men Phase II, Randomized Clinical Trial, Multi-center, MR-Guided vs. 12-core Systematic Random Biopsy, Localized Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized phase II trial studies how well systematic random biopsy or magnetic&#xD;
      resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate&#xD;
      cancer in patients with elevated prostate specific antigen. Systematic random biopsy and&#xD;
      MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To compare the detection of clinically significant prostate cancer (CSPCa) in Arm 1 versus&#xD;
      Arm 2.&#xD;
&#xD;
      II. To compare between African American (AA) and white men the probability of developing&#xD;
      CSPCa within three years of initial biopsy at the start of the study.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine complications and patient morbidity associated with either systematic random&#xD;
      prostate biopsy (SR-Bx) versus (vs) magnetic resonance imaging-ultrasound image fusion biopsy&#xD;
      (MRUS-Bx) + SR-Bx.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To compare Gleason score between MRUS-Bx and radical prostatectomy (RP) specimen among men&#xD;
      who elect RP (~110 in the randomized controlled trial [RCT]).&#xD;
&#xD;
      II. To assess within Arm 1 the detection of CSPCa three months after SR-Bx among men&#xD;
      initially diagnosed with clinically insignificant prostate cancer (CinsPCa) or no cancer.&#xD;
&#xD;
      III. To identify among men invited to participate and those actually enrolled in the RCT:&#xD;
      determinants of study participation.&#xD;
&#xD;
      IV. To identify among men invited to participate and those actually enrolled in the RCT:&#xD;
      determinants of treatment decision (active surveillance [AS] vs radiation vs RP) including&#xD;
      the diagnostic method.&#xD;
&#xD;
      OUTLINE: Patients are randomized into 1 of 2 arms.&#xD;
&#xD;
      ARM I: SR-Bx group&#xD;
&#xD;
        -  Patients undergo SR-Bx&#xD;
&#xD;
             -  If SR-Bx doesn't reveal clinically significant cancer, then MRI in 3 months, and if&#xD;
                lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx.&#xD;
&#xD;
             -  If there is no lesion, then no biopsy - schedule MRI in 12 months after the initial&#xD;
                MRI.&#xD;
&#xD;
      ARM II: MRUS-Bx group&#xD;
&#xD;
        -  Patients undergo MRI. Must be scheduled at least 1 day before MRUS Biopsy.&#xD;
&#xD;
             -  MRI shows no lesion present (PIRADS 1-2): no MRUS-Bx, schedule for SR-Bx only.&#xD;
&#xD;
             -  MRI lesion present (PIRADS ≥ 3): schedule for MRUS-Bx, which will be done first and&#xD;
                followed immediately after by SR-Bx.&#xD;
&#xD;
      FOLLOW UP:&#xD;
&#xD;
      After completion of procedure, patients are followed up at 2-4 weeks, 3, 6, 9, and 12 months,&#xD;
      and then periodically for up to 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Anticipated">September 25, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 25, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biopsy detection rate of clinically significant prostate cancer</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will code patients as having clinically significant prostate cancer if they are diagnosed with Gleason score &gt;= 7 or any Gleason score with core length &gt;= 5 mm or any Gleason score that includes Gleason pattern &gt;= 4 at initial systematic random biopsy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of any of the complications</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will be summarized in the complications checklist. Will determine any striking co-morbidities that are present post-biopsy and were absent pre-biopsy within each arm, and next determine if the prevalence of any of these identified post-biopsy morbidities differs between the two arms. For these analyses, regression methods (linear, logistic, multinomial logistic as appropriate for the &quot;dependent&quot; variable being analyzed) will be used. Standard descriptive methods will be used to summarize and display the results.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Highest Gleason score</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will assess the highest Gleason score in magnetic resonance imaging-ultrasound image fusion biopsy and systematic random biopsy. Will evaluated using agreement metrics such as percent agreement, Cohen's kappa (k) statistic and Krippendorff's alpha statistic. Significance will be considered if p &lt; 0.05.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Health Status Unknown</condition>
  <condition>Elevated PSA</condition>
  <arm_group>
    <arm_group_label>Arm I (SR-Bx)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (MRI, MRUS-Bx, SR-Bx)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo MRI. Must be scheduled at least one day before MRUS biopsy.&#xD;
If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only.&#xD;
If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biopsy of Prostate</intervention_name>
    <description>Undergo SR-Bx</description>
    <arm_group_label>Arm I (SR-Bx)</arm_group_label>
    <arm_group_label>Arm II (MRI, MRUS-Bx, SR-Bx)</arm_group_label>
    <other_name>Prostate Biopsy</other_name>
    <other_name>Prostatic Biopsy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm I (SR-Bx)</arm_group_label>
    <arm_group_label>Arm II (MRI, MRUS-Bx, SR-Bx)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Magnetic Resonance Imaging</intervention_name>
    <description>Undergo MRI</description>
    <arm_group_label>Arm I (SR-Bx)</arm_group_label>
    <arm_group_label>Arm II (MRI, MRUS-Bx, SR-Bx)</arm_group_label>
    <other_name>Magnetic Resonance Imaging Scan</other_name>
    <other_name>Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance</other_name>
    <other_name>MRI</other_name>
    <other_name>MRI Scan</other_name>
    <other_name>NMR Imaging</other_name>
    <other_name>NMRI</other_name>
    <other_name>Nuclear Magnetic Resonance Imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI Ultrasound Fusion Guided Biopsy</intervention_name>
    <description>Undergo MRUS-Bx</description>
    <arm_group_label>Arm I (SR-Bx)</arm_group_label>
    <arm_group_label>Arm II (MRI, MRUS-Bx, SR-Bx)</arm_group_label>
    <other_name>Fusion Biopsy</other_name>
    <other_name>Fusion-Guided Biopsy</other_name>
    <other_name>MR Fusion Biopsy</other_name>
    <other_name>MRI-Ultrasound Fusion Biopsy</other_name>
    <other_name>MRI/Ultrasound Fusion Biopsy</other_name>
    <other_name>MRI/US Biopsy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent and Health Insurance Portability and Accountability Act&#xD;
             (HIPAA) authorization for release of personal health information&#xD;
&#xD;
               -  Note: HIPAA authorization may be included in the informed consent or obtained&#xD;
                  separately&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of =&lt; 1 within 3 months&#xD;
             (93 days) prior to being registered for protocol&#xD;
&#xD;
          -  African-American or white men (Hispanic or non-Hispanic)&#xD;
&#xD;
          -  Prostate biopsy-naive or a single negative biopsy&#xD;
&#xD;
          -  Having elevated prostate specific antigen (PSA) (&gt; 2.5 ng/ml) and no palpable nodule&#xD;
             on digital rectal exam (DRE)&#xD;
&#xD;
          -  Ability to understand the willingness to sign a written informed consent&#xD;
&#xD;
          -  Patients must be willing to undergo a radiologic imaging before and after biopsy of&#xD;
             the prostate&#xD;
&#xD;
          -  Patients must be willing to undergo a biopsy of the prostate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had chemotherapy or radiotherapy within 12 months of the study for&#xD;
             other diagnoses not related to prostate cancer&#xD;
&#xD;
          -  Patients receiving any other investigational agents&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Patients with active inflammatory bowel disease&#xD;
&#xD;
          -  Patients who are unable to undergo MRI&#xD;
&#xD;
          -  Patients who had any surgery of the prostate including TURP (transurethral resection&#xD;
             of the prostate)&#xD;
&#xD;
          -  Patients who had &gt; 1 prior prostate biopsy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Inderbir Gill</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ileana Aldana</last_name>
    <phone>323-865-0702</phone>
    <email>Ileana.aldana@med.usc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ileana Aldana</last_name>
      <phone>323-865-0702</phone>
      <email>Ileana.aldana@med.usc.edu</email>
    </contact>
    <investigator>
      <last_name>Inderbir Gill, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ganine Markowitz-Chrystal</last_name>
      <phone>410-328-0800</phone>
      <email>gmarkowitz@som.umaryland.edu</email>
    </contact>
    <investigator>
      <last_name>Minhaj Siddiqui, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University/Sidney Kimmel Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Inderbir Gill</last_name>
      <phone>323-865-3000</phone>
    </contact>
    <investigator>
      <last_name>Inderbir Gill</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chesapeake Urology Associates</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Inderbir Gill</last_name>
      <phone>323-865-3000</phone>
    </contact>
    <investigator>
      <last_name>Inderbir Gill</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital Vattikuti Urology Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ali A. Dabaja, MD</last_name>
      <phone>313-717-8680</phone>
      <email>adabaja2@hfhs.org</email>
    </contact>
    <contact_backup>
      <last_name>Mustafa Deebajah</last_name>
      <phone>313-717-8680</phone>
      <email>Mdeebaj1@hfhs.org</email>
    </contact_backup>
    <investigator>
      <last_name>James Peabody, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan Coleman, MD</last_name>
      <phone>646-422-4432</phone>
      <email>colemanj@mskcc.org</email>
    </contact>
    <investigator>
      <last_name>Jonathan Coleman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern/Simmons Cancer Center-Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Inderbir Gill</last_name>
      <phone>323-865-3000</phone>
    </contact>
    <investigator>
      <last_name>Inderbir Gill</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</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>
  <!-- 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/NCT03234556
org study id: 4P-16-7
secondary id: NCI-2017-00890
secondary id: 4P-16-7
secondary id: P30CA014089
secondary id: R01CA205058
nct id: NCT03234556
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This randomized phase II trial studies how well systematic random biopsy or magnetic
      resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate
      cancer in patients with elevated prostate specific antigen. Systematic random biopsy and
      MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.
PRIMARY OBJECTIVES:

      I. To compare the detection of clinically significant prostate cancer (CSPCa) in Arm 1 versus
      Arm 2.

      II. To compare between African American (AA) and white men the probability of developing
      CSPCa within three years of initial biopsy at the start of the study.

      SECONDARY OBJECTIVES:

      I. To determine complications and patient morbidity associated with either systematic random
      prostate biopsy (SR-Bx) versus (vs) magnetic resonance imaging-ultrasound image fusion biopsy
      (MRUS-Bx) + SR-Bx.

      TERTIARY OBJECTIVES:

      I. To compare Gleason score between MRUS-Bx and radical prostatectomy (RP) specimen among men
      who elect RP (~110 in the randomized controlled trial [RCT]).

      II. To assess within Arm 1 the detection of CSPCa three months after SR-Bx among men
      initially diagnosed with clinically insignificant prostate cancer (CinsPCa) or no cancer.

      III. To identify among men invited to participate and those actually enrolled in the RCT:
      determinants of study participation.

      IV. To identify among men invited to participate and those actually enrolled in the RCT:
      determinants of treatment decision (active surveillance [AS] vs radiation vs RP) including
      the diagnostic method.

      OUTLINE: Patients are randomized into 1 of 2 arms.

      ARM I: SR-Bx group

        -  Patients undergo SR-Bx

             -  If SR-Bx doesn't reveal clinically significant cancer, then MRI in 3 months, and if
                lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx.

             -  If there is no lesion, then no biopsy - schedule MRI in 12 months after the initial
                MRI.

      ARM II: MRUS-Bx group

        -  Patients undergo MRI. Must be scheduled at least 1 day before MRUS Biopsy.

             -  MRI shows no lesion present (PIRADS 1-2): no MRUS-Bx, schedule for SR-Bx only.

             -  MRI lesion present (PIRADS ≥ 3): schedule for MRUS-Bx, which will be done first and
                followed immediately after by SR-Bx.

      FOLLOW UP:

      After completion of procedure, patients are followed up at 2-4 weeks, 3, 6, 9, and 12 months,
      and then periodically for up to 5 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Biopsy detection rate of clinically significant prostate cancer
time frame: Up to 5 years
description: Will code patients as having clinically significant prostate cancer if they are diagnosed with Gleason score >= 7 or any Gleason score with core length >= 5 mm or any Gleason score that includes Gleason pattern >= 4 at initial systematic random biopsy.
measure: Presence of any of the complications
time frame: Up to 5 years
description: Will be summarized in the complications checklist. Will determine any striking co-morbidities that are present post-biopsy and were absent pre-biopsy within each arm, and next determine if the prevalence of any of these identified post-biopsy morbidities differs between the two arms. For these analyses, regression methods (linear, logistic, multinomial logistic as appropriate for the "dependent" variable being analyzed) will be used. Standard descriptive methods will be used to summarize and display the results.
measure: Highest Gleason score
time frame: Up to 5 years
description: Will assess the highest Gleason score in magnetic resonance imaging-ultrasound image fusion biopsy and systematic random biopsy. Will evaluated using agreement metrics such as percent agreement, Cohen's kappa (k) statistic and Krippendorff's alpha statistic. Significance will be considered if p < 0.05.
arm group label: Arm I (SR-Bx)
arm group type: Active Comparator
description: Patients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI.
arm group label: Arm II (MRI, MRUS-Bx, SR-Bx)
arm group type: Experimental
description: Patients undergo MRI. Must be scheduled at least one day before MRUS biopsy.
If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only.
If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx.
intervention type: Procedure
intervention name: Biopsy of Prostate
description: Undergo SR-Bx
arm group label: Arm I (SR-Bx)
arm group label: Arm II (MRI, MRUS-Bx, SR-Bx)
other name: Prostate Biopsy
other name: Prostatic Biopsy
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Arm I (SR-Bx)
arm group label: Arm II (MRI, MRUS-Bx, SR-Bx)
intervention type: Diagnostic Test
intervention name: Magnetic Resonance Imaging
description: Undergo MRI
arm group label: Arm I (SR-Bx)
arm group label: Arm II (MRI, MRUS-Bx, SR-Bx)
other name: Magnetic Resonance Imaging Scan
other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
other name: MRI
other name: MRI Scan
other name: NMR Imaging
other name: NMRI
other name: Nuclear Magnetic Resonance Imaging
intervention type: Diagnostic Test
intervention name: MRI Ultrasound Fusion Guided Biopsy
description: Undergo MRUS-Bx
arm group label: Arm I (SR-Bx)
arm group label: Arm II (MRI, MRUS-Bx, SR-Bx)
other name: Fusion Biopsy
other name: Fusion-Guided Biopsy
other name: MR Fusion Biopsy
other name: MRI-Ultrasound Fusion Biopsy
other name: MRI/Ultrasound Fusion Biopsy
other name: MRI/US Biopsy
criteria: 
gender: Male
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Inderbir Gill
role: Principal Investigator
affiliation: University of Southern California
last name: Ileana Aldana
phone: 323-865-0702
email: Ileana.aldana@med.usc.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms