<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/NCT04421781</url>
  </required_header>
  <id_info>
    <org_study_id>20_086</org_study_id>
    <nct_id>NCT04421781</nct_id>
  </id_info>
  <brief_title>Salvage HIFU for Local Recurrence in the Prostatic Bed After Prostatectomy and External Beam Radiation Therapy : Preliminary Results</brief_title>
  <acronym>Salvage HIFU</acronym>
  <official_title>Salvage HIFU for Local Recurrence in the Prostatic Bed After Prostatectomy and External Beam Radiation Therapy : Preliminary Results</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Retrospective monocentric analysis performed on patients treated with salvage HIFU for&#xD;
      isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage&#xD;
      or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free&#xD;
      survival), the adverse events and urinary incontinence will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oncological outcomes in the prostatic bed after S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT.</measure>
    <time_frame>December 31, 2019</time_frame>
    <description>Oncological outcomes:&#xD;
Treatment failure-free survival: absence of:&#xD;
recurrent prostate cancer in the prostatic bed and/or&#xD;
metastasis and/or&#xD;
introduction of systemic treatment&#xD;
Progression-free survival: absence of:&#xD;
metastasis and/or&#xD;
introduction of systemic treatment&#xD;
decrease in PSA value: any drop in PSA after S-HIFU, regardless of whether there was subsequent PSA progression&#xD;
BCR-free survival following S-HIFU defined as an absence of two rises in PSA ≥0.2 ng/mL above nadir&#xD;
Functional outcomes:&#xD;
complications (Clavien classification)&#xD;
Urinary incontinence (Ingelman-Sundberg score)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">22</enrollment>
  <condition>Prostatic Cancer</condition>
  <arm_group>
    <arm_group_label>Salvage HIFU for local recurrence after prostatectomy and EBRT</arm_group_label>
    <description>Between July 2005 and November 2018, at Edouard Herriot Hospital (Lyon, France), 22 consecutive patients were treated with S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence were retrospectively reviewed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Retrospectively review of medical data in patients treated by Salvage HIFU for isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage or adjuvant EBRT</intervention_name>
    <description>Patients were treated using dedicated post-EBRT parameters (5-s pulse, 5-s waiting period, 90% of the acoustic power). Between July 2005 and November 2018, at Edouard Herriot Hospital (Lyon, France), 22 consecutive patients were treated with S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence were retrospectively reviewed.</description>
    <arm_group_label>Salvage HIFU for local recurrence after prostatectomy and EBRT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Between July 2005 and November 2018, at Edouard Herriot Hospital (Lyon, France), 22&#xD;
        consecutive patients were treated with S-HIFU for a local recurrence after radical&#xD;
        prostatectomy and salvage or adjuvant EBRT. The oncological outcomes (treatment&#xD;
        failure-free survival, progression-free survival), the adverse events and urinary&#xD;
        incontinence were retrospectively reviewed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient treated by S-HIFU for a single recurrence within the prostatic bed after an&#xD;
             initial RP with curative intent with or without lymphadenectomy followed by salvage or&#xD;
             adjuvant EBRT (with or without pelvic lymph node irradiation) combined or not with&#xD;
             ADT;&#xD;
&#xD;
               -  life expectancy of ≥10 years;&#xD;
&#xD;
               -  histological local recurrence (positive biopsy),&#xD;
&#xD;
               -  negative metastatic evaluation (All patients underwent multiparametric MRI&#xD;
                  (mpMRI) to confirm the relapse in the prostatic bed and Choline PET/CT to exclude&#xD;
                  metastasis (lymph node, visceral or bone metastasis).&#xD;
&#xD;
               -  the use of ADT at BF after S-EBRT was not an exclusion criterion (ADT was&#xD;
                  introduced by the centre referring the patient).&#xD;
&#xD;
               -  no limits were placed on prostate cancer characteristics, PSA (value, doubling&#xD;
                  time (PSA-DT)), Gleason score and location of suspected recurrence in relation to&#xD;
                  the sphincter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who do not meet the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>86 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Urology and Transplantation Surgery, Edouard Herriot Hospital,</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</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>
    <mesh_term>Recurrence</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/NCT04421781
org study id: 20_086
nct id: NCT04421781
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective monocentric analysis performed on patients treated with salvage HIFU for
      isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage
      or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free
      survival), the adverse events and urinary incontinence will be evaluated.
observational model: Cohort
time perspective: Retrospective
measure: Oncological outcomes in the prostatic bed after S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT.
time frame: December 31, 2019
description: Oncological outcomes:
Treatment failure-free survival: absence of:
recurrent prostate cancer in the prostatic bed and/or
metastasis and/or
introduction of systemic treatment
Progression-free survival: absence of:
metastasis and/or
introduction of systemic treatment
decrease in PSA value: any drop in PSA after S-HIFU, regardless of whether there was subsequent PSA progression
BCR-free survival following S-HIFU defined as an absence of two rises in PSA ≥0.2 ng/mL above nadir
Functional outcomes:
complications (Clavien classification)
Urinary incontinence (Ingelman-Sundberg score)
arm group label: Salvage HIFU for local recurrence after prostatectomy and EBRT
description: Between July 2005 and November 2018, at Edouard Herriot Hospital (Lyon, France), 22 consecutive patients were treated with S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence were retrospectively reviewed.
intervention type: Other
intervention name: Retrospectively review of medical data in patients treated by Salvage HIFU for isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage or adjuvant EBRT
description: Patients were treated using dedicated post-EBRT parameters (5-s pulse, 5-s waiting period, 90% of the acoustic power). Between July 2005 and November 2018, at Edouard Herriot Hospital (Lyon, France), 22 consecutive patients were treated with S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence were retrospectively reviewed.
arm group label: Salvage HIFU for local recurrence after prostatectomy and EBRT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 60 Years
maximum age: 86 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Recurrence