<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/NCT02265159</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH-Nr. 2013-0415</org_study_id>
    <nct_id>NCT02265159</nct_id>
  </id_info>
  <brief_title>Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer</brief_title>
  <official_title>Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to evaluate cancer control, genitourinary, rectal and overall&#xD;
      health-related quality of life outcomes and effectiveness of focal therapy for localised&#xD;
      prostate cancer using High Intensity Focused Ultrasound (HIFU).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">May 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oncological safety</measure>
    <time_frame>36 months</time_frame>
    <description>To determine the proportion of men who are free of clinically significant prostate cancer in the treated area AND are free of clinically significant prostate cancer in the untreated area 36 months after focal therapy using HIFU</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oncological safety</measure>
    <time_frame>36 months</time_frame>
    <description>To determine the proportion of men who are free of any prostate cancer in the treated area AND are free of clinically significant prostate cancer in the untreated area 36 months after focal therapy using HIFU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical failure</measure>
    <time_frame>36 months</time_frame>
    <description>To analyse the rate of biochemical recurrence by measuring PSA values following focal therapy using HIFU:&#xD;
biochemical recurrence defined according to the Phoenix Consensus OR&#xD;
by PSA velocity &gt;1 ng/ml/year OR PSA doubling time &lt;/=3 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and specificity of MRI imaging</measure>
    <time_frame>36 months</time_frame>
    <description>To determine the clinical validity (area under the receiver operating characteristics curve (AUC), sensitivity, specificity, negative and positive predictive values, inter-observer variability) of&#xD;
multi-parametric MR-imaging to predict presence of clinically significant prostate cancer on transperineal template prostate mapping biopsies prior to focal therapy&#xD;
MR-imaging changes to predict presence of residual/recurrent clinically significant prostate cancer on biopsy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care costs</measure>
    <time_frame>36 months</time_frame>
    <description>To determine the costs of treatment and longitudinal morbidity associated with complications at 36 months compared to other treatments of localized prostate cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erectile function</measure>
    <time_frame>36 months</time_frame>
    <description>Rate of erectile dysfunction and time to return of erectile function (measured by the IIEF-15)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orgasmic function</measure>
    <time_frame>36 months</time_frame>
    <description>Rate of loss of ejaculation and orgasm (measured by the IIEF-15)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual function</measure>
    <time_frame>36 months</time_frame>
    <description>Rate of pain during intercourse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erectile function</measure>
    <time_frame>36 months</time_frame>
    <description>Number of men using phosphodiesterase-5 inhibitors to maintain erectile function (measured by the IIEF-15)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continence</measure>
    <time_frame>36 months</time_frame>
    <description>Rate of urinary incontinence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continence</measure>
    <time_frame>36 months</time_frame>
    <description>Time to return of continence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower urinary tract symptoms</measure>
    <time_frame>36 months</time_frame>
    <description>Rate of lower urinary tract symptoms (as determined by IPSS scores)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel function</measure>
    <time_frame>36 months</time_frame>
    <description>Rate of bowel toxicity (determined by the UCLA-EPIC Bowel questionnaire )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>36 months</time_frame>
    <description>Anxiety levels (measured by the Hospital Anxiety and Depression Scale and Memorial Anxiety Scale for Prostate Cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>36 months</time_frame>
    <description>General health related quality of life (measured using FACT-P Version 4 )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General histological outcome</measure>
    <time_frame>36 months</time_frame>
    <description>To determine the histological outcomes at 6, 12 and 36 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary intervention</measure>
    <time_frame>36 months</time_frame>
    <description>Rate of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Focal Therapy Using High Intensity Focused Ultrasound</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Focal Therapy Using High Intensity Focused Ultrasound</intervention_name>
    <arm_group_label>Focal Therapy Using High Intensity Focused Ultrasound</arm_group_label>
    <other_name>Focal HIFU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven prostate cancer on trans-rectal or transperineal template&#xD;
             prostate biopsies&#xD;
&#xD;
          -  Template biopsy:&#xD;
&#xD;
               -  unilateral disease (Gleason ≤4+3)&#xD;
&#xD;
               -  bilateral disease: presence of clinically significant cancer in both sides&#xD;
                  (Gleason ≤4+3) OR clinically insignificant disease with a burden of &gt;50% of&#xD;
                  biopsy cores taken on that side, OR bilateral clinically insignificant disease&#xD;
                  and &lt;50% of biopsy cores positive on any one side but with dominant disease&#xD;
                  burden on one side&#xD;
&#xD;
          -  Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a&#xD;
             permitted)&#xD;
&#xD;
          -  Serum PSA ≤15&#xD;
&#xD;
          -  Life expectancy of ≥10 years&#xD;
&#xD;
          -  Signed informed consent by patient&#xD;
&#xD;
          -  An understanding of the German language sufficient to understand written and verbal&#xD;
             information about the trial and consent process&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men who have had androgen suppression/hormone treatment within the previous 12 months&#xD;
             for their prostate cancer&#xD;
&#xD;
          -  Men with evidence of metastatic disease or nodal disease outside the prostate on bone&#xD;
             scan or cross-sectional imaging&#xD;
&#xD;
          -  Men with an inability to tolerate a transrectal ultrasound&#xD;
&#xD;
          -  Men with latex allergies as the HIFU probe is covered with a latex condom sheath prior&#xD;
             to insertion into the back passage&#xD;
&#xD;
          -  Men who have undergone prior significant rectal surgery preventing insertion of&#xD;
             trans-rectal HIFU probe (decided on the type of surgery in individual cases)&#xD;
&#xD;
          -  Men who have had previous HIFU, cryosurgery, thermal or microwave therapy to the&#xD;
             prostate.&#xD;
&#xD;
          -  Men who have undergone a Transurethral Resection of the Prostate (TURP) for&#xD;
             symptomatic lower urinary tract symptoms within 6 months. These patients may be&#xD;
             included within the trial if deferred from consenting and screening until at least 6&#xD;
             months following the TURP.&#xD;
&#xD;
          -  Men not fit for major surgery as assessed by a Consultant Anaesthetist&#xD;
&#xD;
          -  Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac&#xD;
             pacemaker, metallic implant etc likely to contribute significant artefact to images)&#xD;
&#xD;
          -  Presence of metal implants/stents in the urethra&#xD;
&#xD;
          -  Presence of prostatic calcification and cysts (on transrectal ultrasound) whose&#xD;
             location will interfere with effective delivery of HIFU therapy&#xD;
&#xD;
          -  Men with renal impairment with a glomerular filtration rate of &lt;35ml/min (unable to&#xD;
             tolerate Gadolinium dynamic contrast enhanced MRI).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Eberli, PD Dr. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Urologie, Universitätsspital Zürich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel Eberli, PD Dr. PhD</last_name>
    <phone>+41 44 255 95 49</phone>
    <email>Daniel.Eberli@usz.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ashkan Mortezavi, Dr.</last_name>
    <phone>+41 44 255 11 11</phone>
    <email>Ashkan.Mortezavi@usz.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Klinik für Urologie, Universitätsspital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8044</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Eberli, PD Dr. PhD</last_name>
      <phone>+41 44 255 95 49</phone>
      <email>Daniel.Eberli@usz.ch</email>
    </contact>
    <contact_backup>
      <last_name>Ashkan Mortezavi, Dr.</last_name>
      <phone>+41 44 255 11 11</phone>
      <email>Ashkan.Mortezavi@usz.ch</email>
    </contact_backup>
    <investigator>
      <last_name>Daniel Eberli, PD Dr. PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tullio Sulser, Prof.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ashkan Mortezavi, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 26, 2016</last_update_submitted>
  <last_update_submitted_qc>October 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Daniel Eberli</investigator_full_name>
    <investigator_title>PD Dr. med. PhD</investigator_title>
  </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/NCT02265159
org study id: KEK-ZH-Nr. 2013-0415
nct id: NCT02265159
lead sponsor: 
collaborator: 
has dmc: No
The investigators aim to evaluate cancer control, genitourinary, rectal and overall
      health-related quality of life outcomes and effectiveness of focal therapy for localised
      prostate cancer using High Intensity Focused Ultrasound (HIFU).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Oncological safety
time frame: 36 months
description: To determine the proportion of men who are free of clinically significant prostate cancer in the treated area AND are free of clinically significant prostate cancer in the untreated area 36 months after focal therapy using HIFU
measure: Oncological safety
time frame: 36 months
description: To determine the proportion of men who are free of any prostate cancer in the treated area AND are free of clinically significant prostate cancer in the untreated area 36 months after focal therapy using HIFU
measure: Biochemical failure
time frame: 36 months
description: To analyse the rate of biochemical recurrence by measuring PSA values following focal therapy using HIFU:
biochemical recurrence defined according to the Phoenix Consensus OR
by PSA velocity >1 ng/ml/year OR PSA doubling time </=3 years
measure: Sensitivity and specificity of MRI imaging
time frame: 36 months
description: To determine the clinical validity (area under the receiver operating characteristics curve (AUC), sensitivity, specificity, negative and positive predictive values, inter-observer variability) of
multi-parametric MR-imaging to predict presence of clinically significant prostate cancer on transperineal template prostate mapping biopsies prior to focal therapy
MR-imaging changes to predict presence of residual/recurrent clinically significant prostate cancer on biopsy
measure: Health care costs
time frame: 36 months
description: To determine the costs of treatment and longitudinal morbidity associated with complications at 36 months compared to other treatments of localized prostate cancer.
measure: Erectile function
time frame: 36 months
description: Rate of erectile dysfunction and time to return of erectile function (measured by the IIEF-15)
measure: Orgasmic function
time frame: 36 months
description: Rate of loss of ejaculation and orgasm (measured by the IIEF-15)
measure: Sexual function
time frame: 36 months
description: Rate of pain during intercourse
measure: Erectile function
time frame: 36 months
description: Number of men using phosphodiesterase-5 inhibitors to maintain erectile function (measured by the IIEF-15)
measure: Continence
time frame: 36 months
description: Rate of urinary incontinence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)
measure: Continence
time frame: 36 months
description: Time to return of continence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)
measure: Lower urinary tract symptoms
time frame: 36 months
description: Rate of lower urinary tract symptoms (as determined by IPSS scores)
measure: Bowel function
time frame: 36 months
description: Rate of bowel toxicity (determined by the UCLA-EPIC Bowel questionnaire )
measure: Anxiety
time frame: 36 months
description: Anxiety levels (measured by the Hospital Anxiety and Depression Scale and Memorial Anxiety Scale for Prostate Cancer
measure: Quality of life
time frame: 36 months
description: General health related quality of life (measured using FACT-P Version 4 )
measure: General histological outcome
time frame: 36 months
description: To determine the histological outcomes at 6, 12 and 36 months
measure: Secondary intervention
time frame: 36 months
description: Rate of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation)
arm group label: Focal Therapy Using High Intensity Focused Ultrasound
arm group type: Other
intervention type: Procedure
intervention name: Focal Therapy Using High Intensity Focused Ultrasound
arm group label: Focal Therapy Using High Intensity Focused Ultrasound
other name: Focal HIFU
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 99 Years
healthy volunteers: No
last name: Daniel Eberli, PD Dr. PhD
role: Principal Investigator
affiliation: Klinik für Urologie, Universitätsspital Zürich
last name: Daniel Eberli, PD Dr. PhD
phone: +41 44 255 95 49
email: Daniel.Eberli@usz.ch
last name: Ashkan Mortezavi, Dr.
phone: +41 44 255 11 11
email: Ashkan.Mortezavi@usz.ch
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Zurich
investigator full name: Daniel Eberli
investigator title: PD Dr. med. PhD
mesh term: Prostatic Neoplasms