<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/NCT03819751</url>
  </required_header>
  <id_info>
    <org_study_id>s.nr</org_study_id>
    <nct_id>NCT03819751</nct_id>
  </id_info>
  <brief_title>MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection</brief_title>
  <acronym>PROSOVI</acronym>
  <official_title>MRI-targeted Biopsy of the Prostate: a Prospective Comparison of Software-based Fusion Versus Visual (Cognitive) Registration in the Accuracy of Clinically Significant Prostate Cancer Detection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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>
      With the general acceptance of MRI and technical advances in biopsy technique of the&#xD;
      prostate, new questions arise concerning the selection of patients, the approach, the&#xD;
      appropriate technique, the lesions to target and the number of biopsies. The purpose of this&#xD;
      study is to address these issues in men suspicious of having prostate cancer and without&#xD;
      prior biopsies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trial Design: This is a prospective, single center, comparative, diagnostic study of two&#xD;
      biopsy techniques. All men aged 50 to 75 years with clinical suspicion of PCa (elevated&#xD;
      prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination)&#xD;
      and an MRI with suspicious lesion(s) (presence of PI-RADS 3-5 lesion) will be included.&#xD;
      Participants receive both types of biopsy, but will be randomized concerning the order of the&#xD;
      biopsy. All men will also receive traditional systematic biopsies. Treatment and further&#xD;
      follow-up is according to EAU guidelines. Data of treatment and follow-up will be retrieved&#xD;
      till 2 years after initial MRI-visit.&#xD;
&#xD;
      Sample Size: Based on McNemar test for the comparison between the accuracy of the two biopsy&#xD;
      techniques, the required sample size is estimated on 96 patients.&#xD;
&#xD;
      Assessment of efficacy: Efficacy of software and visual registration biopsy will be&#xD;
      determined by histopathology: cancer core length (actual length and percentage) and&#xD;
      comparison with systematic biopsy as reference standard.&#xD;
&#xD;
      Direct access to source data and documents: The investigator(s) and the institution(s) will&#xD;
      permit trial-related monitoring, audits, EC review, and regulatory inspections (where&#xD;
      appropriate) by providing direct access to source data and other documents (i.e. patients'&#xD;
      case sheets, blood test reports, X-ray reports, histology reports, etc.).&#xD;
&#xD;
      Data handling and management: All data collected during the study remain confidential and&#xD;
      according to the GDPR regulation. Data of the participants will be retrieved from their&#xD;
      electronic patient files. Each participant will be given a unique identification number. When&#xD;
      data are coded, there continues to be a link between the data and the individual who provided&#xD;
      it. The research team is obligated to protect the data from disclosure outside the research&#xD;
      according to the terms of the research protocol and the informed consent document. The&#xD;
      subject's name or other identifiers should be stored separately (site file) from their&#xD;
      research data and replaced with a unique code to create a new identity for the subject. Note&#xD;
      that coded data are not anonymous. All data is collected and stored electronically by the&#xD;
      principal investigator and co-investigators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">February 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All patients receive both types of biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of the two MR-guided registration techniques (visual and software-based) in the detection of clinically significant prostate cancer</measure>
    <time_frame>From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit</time_frame>
    <description>Assessment of the detection rate of clinically significant prostate cancer of software registration biopsy and visual registration biopsy, using traditional TRUS-guided systematic biopsy, whole mount radical prostatectomy specimen and follow-up as reference.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analysis of the performance of software versus visual registration biopsy in subgroups</measure>
    <time_frame>From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit</time_frame>
    <description>Assessment of the performance of software registration biopsy and visual registration biopsy in the detection of clinically significant cancer in :&#xD;
lesions in small volume prostates (&lt;50 gram) versus large volume prostates (&gt;50 gram).&#xD;
transitional zone versus peripheral zone lesions&#xD;
basal versus apical lesions&#xD;
small (max. diameter &lt; or = 10 mm) versus large lesions (max. diameter &gt; 10 mm)&#xD;
intermediate suspicious lesions (PI-RADS 3) versus highly suspicious lesions (PI-RADS 4-5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Added value of systematic biopsies</measure>
    <time_frame>From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit</time_frame>
    <description>Assessment of the added value of systematic biopsies on top of MRI-targeted biopsy of PI-RADS 3, 4 and 5 lesions. Compare MRI-targeted + systematic biopsies versus MRI-targeted biopsies alone in T-staging and therapy options.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discriminative features of PI-RADS 3 lesions on MRI</measure>
    <time_frame>From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit</time_frame>
    <description>Lesion diameters, shape, intensity on T2 and aspect, ADC-values on ADC-map will be measured to identify possible discriminative features of 'malignant' s &quot;benigne&quot; PI-RADS 3 lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Features of prostate cancer differentiation grade on MRI</measure>
    <time_frame>From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit</time_frame>
    <description>Measure ADC-value to differentiate prostate cancer differentiation grade.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Prostate Neoplasm</condition>
  <arm_group>
    <arm_group_label>MRI-targeted prostate biopsy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants receive both type of MRI-targeted biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MRI-targeted prostate biopsy</intervention_name>
    <description>All participants receive traditional cognitive/visual registration biopsy and the above mentioned MRI/TRUS fusion biopsy (also known as software registration biopsy)</description>
    <arm_group_label>MRI-targeted prostate biopsy</arm_group_label>
    <other_name>MRI/TRUS fusion biopsy with Philips Percunav</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  willing to participate in the study by giving written informed consent.&#xD;
&#xD;
          -  male subjects aged between 50 to 75 years.&#xD;
&#xD;
          -  with a clinical suspicion of PCa: elevated prostate specific antigen (PSA) levels in&#xD;
             blood and/or abnormal digital rectal examination (DRE).&#xD;
&#xD;
          -  good health condition based on medical history, physical examination and vital sign&#xD;
             measurements.&#xD;
&#xD;
          -  with target lesion on dedicated MRI of the prostate (PI-RADS 3 to 5).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has a prior history of prostate cancer.&#xD;
&#xD;
          -  had prior prostate biopsy.&#xD;
&#xD;
          -  has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).&#xD;
&#xD;
          -  has evidence of lymph nodes involvement on prostate MRI or abdominal CT&#xD;
&#xD;
          -  has evidence of bone metastasis on bone scan.&#xD;
&#xD;
          -  has a prior history of hip prosthesis, pelvic radiation therapy or androgen&#xD;
             deprivation therapy&#xD;
&#xD;
          -  unable to perform transrectal ultrasound due to prior rectal surgery or active rectal&#xD;
             diseases (rectitis, …)&#xD;
&#xD;
          -  has any condition, physical, mental, familial or sociological, that could impede&#xD;
             compliance with the study protocol and further follow-up. This is not an absolute&#xD;
             contra-indication, but should be discussed with patient prior to registration in the&#xD;
             trial.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participants need to have a prostate.</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cindy Mai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Leuven, Department of Radiology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cindy Mai, MD</last_name>
    <phone>016345032</phone>
    <phone_ext>016345032</phone_ext>
    <email>cindy.mai@uzleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Frederik De Keyzer</last_name>
    <phone>016347755</phone>
    <phone_ext>016345032</phone_ext>
    <email>frederik.dekeyzer@uzleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cindy Mai, MD</last_name>
      <phone>003216345032</phone>
      <email>cindy.mai@uzleuven.be</email>
    </contact>
    <contact_backup>
      <last_name>Hilde Vandenhout</last_name>
      <phone>003216343636</phone>
      <email>hilde.vandenhout@uzleuven.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.</citation>
    <PMID>27568654</PMID>
  </reference>
  <reference>
    <citation>Futterer JJ, Briganti A, De Visschere P, Emberton M, Giannarini G, Kirkham A, Taneja SS, Thoeny H, Villeirs G, Villers A. Can Clinically Significant Prostate Cancer Be Detected with Multiparametric Magnetic Resonance Imaging? A Systematic Review of the Literature. Eur Urol. 2015 Dec;68(6):1045-53. doi: 10.1016/j.eururo.2015.01.013. Epub 2015 Feb 2.</citation>
    <PMID>25656808</PMID>
  </reference>
  <reference>
    <citation>Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.</citation>
    <PMID>28110982</PMID>
  </reference>
  <reference>
    <citation>Kasivisvanathan V, Emberton M, Moore CM. MRI-Targeted Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 Aug 9;379(6):589-590. doi: 10.1056/NEJMc1807507. No abstract available.</citation>
    <PMID>30089067</PMID>
  </reference>
  <reference>
    <citation>Moore CM, Robertson NL, Arsanious N, Middleton T, Villers A, Klotz L, Taneja SS, Emberton M. Image-guided prostate biopsy using magnetic resonance imaging-derived targets: a systematic review. Eur Urol. 2013 Jan;63(1):125-40. doi: 10.1016/j.eururo.2012.06.004. Epub 2012 Jun 13.</citation>
    <PMID>22743165</PMID>
  </reference>
  <reference>
    <citation>Logan JK, Rais-Bahrami S, Turkbey B, Gomella A, Amalou H, Choyke PL, Wood BJ, Pinto PA. Current status of magnetic resonance imaging (MRI) and ultrasonography fusion software platforms for guidance of prostate biopsies. BJU Int. 2014 Nov;114(5):641-52. doi: 10.1111/bju.12593. Epub 2014 May 22.</citation>
    <PMID>24298917</PMID>
  </reference>
  <reference>
    <citation>Wysock JS, Rosenkrantz AB, Huang WC, Stifelman MD, Lepor H, Deng FM, Melamed J, Taneja SS. A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial. Eur Urol. 2014 Aug;66(2):343-51. doi: 10.1016/j.eururo.2013.10.048. Epub 2013 Nov 8.</citation>
    <PMID>24262102</PMID>
  </reference>
  <reference>
    <citation>Puech P, Rouviere O, Renard-Penna R, Villers A, Devos P, Colombel M, Bitker MO, Leroy X, Mege-Lechevallier F, Comperat E, Ouzzane A, Lemaitre L. Prostate cancer diagnosis: multiparametric MR-targeted biopsy with cognitive and transrectal US-MR fusion guidance versus systematic biopsy--prospective multicenter study. Radiology. 2013 Aug;268(2):461-9. doi: 10.1148/radiol.13121501. Epub 2013 Apr 11.</citation>
    <PMID>23579051</PMID>
  </reference>
  <reference>
    <citation>Moore CM, Kasivisvanathan V, Eggener S, Emberton M, Futterer JJ, Gill IS, Grubb Iii RL, Hadaschik B, Klotz L, Margolis DJ, Marks LS, Melamed J, Oto A, Palmer SL, Pinto P, Puech P, Punwani S, Rosenkrantz AB, Schoots IG, Simon R, Taneja SS, Turkbey B, Ukimura O, van der Meulen J, Villers A, Watanabe Y; START Consortium. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an International Working Group. Eur Urol. 2013 Oct;64(4):544-52. doi: 10.1016/j.eururo.2013.03.030. Epub 2013 Mar 20.</citation>
    <PMID>23537686</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>June 14, 2019</last_update_submitted>
  <last_update_submitted_qc>June 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostatic neoplasms</keyword>
  <keyword>biopsy</keyword>
  <keyword>Multimodal Imaging</keyword>
  <keyword>prostate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03819751
org study id: s.nr
nct id: NCT03819751
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With the general acceptance of MRI and technical advances in biopsy technique of the
      prostate, new questions arise concerning the selection of patients, the approach, the
      appropriate technique, the lesions to target and the number of biopsies. The purpose of this
      study is to address these issues in men suspicious of having prostate cancer and without
      prior biopsies.
Trial Design: This is a prospective, single center, comparative, diagnostic study of two
      biopsy techniques. All men aged 50 to 75 years with clinical suspicion of PCa (elevated
      prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination)
      and an MRI with suspicious lesion(s) (presence of PI-RADS 3-5 lesion) will be included.
      Participants receive both types of biopsy, but will be randomized concerning the order of the
      biopsy. All men will also receive traditional systematic biopsies. Treatment and further
      follow-up is according to EAU guidelines. Data of treatment and follow-up will be retrieved
      till 2 years after initial MRI-visit.

      Sample Size: Based on McNemar test for the comparison between the accuracy of the two biopsy
      techniques, the required sample size is estimated on 96 patients.

      Assessment of efficacy: Efficacy of software and visual registration biopsy will be
      determined by histopathology: cancer core length (actual length and percentage) and
      comparison with systematic biopsy as reference standard.

      Direct access to source data and documents: The investigator(s) and the institution(s) will
      permit trial-related monitoring, audits, EC review, and regulatory inspections (where
      appropriate) by providing direct access to source data and other documents (i.e. patients'
      case sheets, blood test reports, X-ray reports, histology reports, etc.).

      Data handling and management: All data collected during the study remain confidential and
      according to the GDPR regulation. Data of the participants will be retrieved from their
      electronic patient files. Each participant will be given a unique identification number. When
      data are coded, there continues to be a link between the data and the individual who provided
      it. The research team is obligated to protect the data from disclosure outside the research
      according to the terms of the research protocol and the informed consent document. The
      subject's name or other identifiers should be stored separately (site file) from their
      research data and replaced with a unique code to create a new identity for the subject. Note
      that coded data are not anonymous. All data is collected and stored electronically by the
      principal investigator and co-investigators.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All patients receive both types of biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Accuracy of the two MR-guided registration techniques (visual and software-based) in the detection of clinically significant prostate cancer
time frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
description: Assessment of the detection rate of clinically significant prostate cancer of software registration biopsy and visual registration biopsy, using traditional TRUS-guided systematic biopsy, whole mount radical prostatectomy specimen and follow-up as reference.
measure: Analysis of the performance of software versus visual registration biopsy in subgroups
time frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
description: Assessment of the performance of software registration biopsy and visual registration biopsy in the detection of clinically significant cancer in :
lesions in small volume prostates (<50 gram) versus large volume prostates (>50 gram).
transitional zone versus peripheral zone lesions
basal versus apical lesions
small (max. diameter < or = 10 mm) versus large lesions (max. diameter > 10 mm)
intermediate suspicious lesions (PI-RADS 3) versus highly suspicious lesions (PI-RADS 4-5).
measure: Added value of systematic biopsies
time frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
description: Assessment of the added value of systematic biopsies on top of MRI-targeted biopsy of PI-RADS 3, 4 and 5 lesions. Compare MRI-targeted + systematic biopsies versus MRI-targeted biopsies alone in T-staging and therapy options.
measure: Discriminative features of PI-RADS 3 lesions on MRI
time frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
description: Lesion diameters, shape, intensity on T2 and aspect, ADC-values on ADC-map will be measured to identify possible discriminative features of 'malignant' s "benigne" PI-RADS 3 lesions.
measure: Features of prostate cancer differentiation grade on MRI
time frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
description: Measure ADC-value to differentiate prostate cancer differentiation grade.
arm group label: MRI-targeted prostate biopsy
arm group type: Other
description: Participants receive both type of MRI-targeted biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first.
intervention type: Procedure
intervention name: MRI-targeted prostate biopsy
description: All participants receive traditional cognitive/visual registration biopsy and the above mentioned MRI/TRUS fusion biopsy (also known as software registration biopsy)
arm group label: MRI-targeted prostate biopsy
other name: MRI/TRUS fusion biopsy with Philips Percunav
criteria: 
gender: Male
gender based: Yes
gender description: Participants need to have a prostate.
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: Cindy Mai, MD
role: Principal Investigator
affiliation: University Hospital Leuven, Department of Radiology
last name: Cindy Mai, MD
phone: 016345032
phone ext: 016345032
email: cindy.mai@uzleuven.be
last name: Frederik De Keyzer
phone: 016347755
phone ext: 016345032
email: frederik.dekeyzer@uzleuven.be
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
citation: Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.
PMID: 27568654
citation: Futterer JJ, Briganti A, De Visschere P, Emberton M, Giannarini G, Kirkham A, Taneja SS, Thoeny H, Villeirs G, Villers A. Can Clinically Significant Prostate Cancer Be Detected with Multiparametric Magnetic Resonance Imaging? A Systematic Review of the Literature. Eur Urol. 2015 Dec;68(6):1045-53. doi: 10.1016/j.eururo.2015.01.013. Epub 2015 Feb 2.
PMID: 25656808
citation: Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
PMID: 28110982
citation: Kasivisvanathan V, Emberton M, Moore CM. MRI-Targeted Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 Aug 9;379(6):589-590. doi: 10.1056/NEJMc1807507. No abstract available.
PMID: 30089067
citation: Moore CM, Robertson NL, Arsanious N, Middleton T, Villers A, Klotz L, Taneja SS, Emberton M. Image-guided prostate biopsy using magnetic resonance imaging-derived targets: a systematic review. Eur Urol. 2013 Jan;63(1):125-40. doi: 10.1016/j.eururo.2012.06.004. Epub 2012 Jun 13.
PMID: 22743165
citation: Logan JK, Rais-Bahrami S, Turkbey B, Gomella A, Amalou H, Choyke PL, Wood BJ, Pinto PA. Current status of magnetic resonance imaging (MRI) and ultrasonography fusion software platforms for guidance of prostate biopsies. BJU Int. 2014 Nov;114(5):641-52. doi: 10.1111/bju.12593. Epub 2014 May 22.
PMID: 24298917
citation: Wysock JS, Rosenkrantz AB, Huang WC, Stifelman MD, Lepor H, Deng FM, Melamed J, Taneja SS. A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial. Eur Urol. 2014 Aug;66(2):343-51. doi: 10.1016/j.eururo.2013.10.048. Epub 2013 Nov 8.
PMID: 24262102
citation: Puech P, Rouviere O, Renard-Penna R, Villers A, Devos P, Colombel M, Bitker MO, Leroy X, Mege-Lechevallier F, Comperat E, Ouzzane A, Lemaitre L. Prostate cancer diagnosis: multiparametric MR-targeted biopsy with cognitive and transrectal US-MR fusion guidance versus systematic biopsy--prospective multicenter study. Radiology. 2013 Aug;268(2):461-9. doi: 10.1148/radiol.13121501. Epub 2013 Apr 11.
PMID: 23579051
citation: Moore CM, Kasivisvanathan V, Eggener S, Emberton M, Futterer JJ, Gill IS, Grubb Iii RL, Hadaschik B, Klotz L, Margolis DJ, Marks LS, Melamed J, Oto A, Palmer SL, Pinto P, Puech P, Punwani S, Rosenkrantz AB, Schoots IG, Simon R, Taneja SS, Turkbey B, Ukimura O, van der Meulen J, Villers A, Watanabe Y; START Consortium. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an International Working Group. Eur Urol. 2013 Oct;64(4):544-52. doi: 10.1016/j.eururo.2013.03.030. Epub 2013 Mar 20.
PMID: 23537686
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No