<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/NCT01717677</url>
  </required_header>
  <id_info>
    <org_study_id>AP 65/11</org_study_id>
    <secondary_id>DRKS00004405</secondary_id>
    <nct_id>NCT01717677</nct_id>
  </id_info>
  <brief_title>Evaluation of Four Treatment Modalities in Prostate Cancer With Low or &quot;Early Intermediate&quot; Risk</brief_title>
  <acronym>PREFERE</acronym>
  <official_title>Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or &quot;Early Intermediate&quot; Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association of Urologic Oncology (AUO)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Association of Urologic Oncology (AUO)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      4arms preference based Study to compare four therapy options in prostate cancer with low or&#xD;
      early intermediate risk&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will compare four possible therapy options for treatment of newly diagnosed&#xD;
      prostate cancer with low or &quot;early intermediate&quot; risk according to the patients preferences.&#xD;
&#xD;
      The Following hypotheses will be tested:&#xD;
&#xD;
        -  Radiation is not relevantly worse compared to prostatectomy with regard to time to&#xD;
           prostate cancer-related deaths&#xD;
&#xD;
        -  Permanent seed implantation therapy not inferior to prostatectomy with regard to time to&#xD;
           prostate cancer-related deaths.&#xD;
&#xD;
        -  Active Surveillance does not lead to a significant decrease of time to prostate&#xD;
           cancer-related deaths compared to prostatectomy.&#xD;
&#xD;
      That for patients with newly diagnosed prostate cancer will be randomized into one of the&#xD;
      four treatment arms. Randomization may be limited to at least two of the four treatment arms&#xD;
      if a patient refuses one or two of the four treatment arms according to his own preference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient Recruitment&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prostate cancer-specific survival</measure>
    <time_frame>minimal observation time of 13 years for last study patient</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>- Overall survival</measure>
    <time_frame>minimal observation time of 13 years for last study patient</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>- Time to onset of hormone therapy</measure>
    <time_frame>17 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>- Occurrence of the first progression on hormone therapy</measure>
    <time_frame>17 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>- Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at baseline</measure>
    <time_frame>before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>- Complications / Safety</measure>
    <time_frame>median 15 years</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">457</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>radical prostatectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Procedure/Surgery: radical prostatectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>percutaneous radiation therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiation: percutaneous radiation therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>permanent seed implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiation: permanent seed implantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Surveillance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Procedure/Surgery: Active Surveillance</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>radical prostatectomy</intervention_name>
    <arm_group_label>radical prostatectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>percutaneous radiation therapy</intervention_name>
    <arm_group_label>percutaneous radiation therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>permanent seed implantation</intervention_name>
    <arm_group_label>permanent seed implantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Active Surveillance</intervention_name>
    <arm_group_label>Active Surveillance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed, biopsy proven adenocarcinoma of the prostate (ultrasound guided&#xD;
             biopsy by standardized protocol)&#xD;
&#xD;
          -  Men aged 18-75 years&#xD;
&#xD;
          -  Recruitment within 3 months after histological confirmation&#xD;
&#xD;
          -  Localized prostata cancer &lt;= cT2a, NX or N0 M0&#xD;
&#xD;
          -  PSA &lt;= 10 ng / ml&#xD;
&#xD;
          -  Gleason score &lt;= 7a (3 +4)&#xD;
&#xD;
          -  ECOG performance status 0 or 1&#xD;
&#xD;
          -  &lt;= 30% positive biopsy cores with largest contiguous tumor length &lt;= 5 mm&#xD;
&#xD;
          -  IPSS score &lt; 18&#xD;
&#xD;
          -  Urine flow (Qmax):&gt; 15 ml / s&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unifocal Gleason 6 cancer &lt;1mm&#xD;
&#xD;
          -  History of treatment for BPH e.g. TURP, HIFU or cryotherapy&#xD;
&#xD;
          -  History of radiation therapy to the pelvis&#xD;
&#xD;
          -  Life expectancy &lt;10 years&#xD;
&#xD;
          -  ASA &gt;= 4&#xD;
&#xD;
          -  Post-void residual urine &gt; 50 ml&#xD;
&#xD;
          -  Prostate volume on transrectal ultrasound &gt; 60 cm3&#xD;
&#xD;
          -  large median prostate lobe visualized on transrectal ultrasound&#xD;
&#xD;
          -  chronic intestinal inflammatory disease covering the rectum&#xD;
&#xD;
          -  Other active malignancy within the past 5 years (except for superficial basal cell&#xD;
             carcinoma or non muscle infiltrating bladder carcinoma)&#xD;
&#xD;
          -  contraindications for prostatectomy, radiation therapy or Active Surveillance&#xD;
&#xD;
          -  Patients refusing written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Stöckle, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Urologie und Kinderurologie der Universität des Saarlandes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Wiegel, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Strahlentherapie und Radioonkologie der Universität Ulm</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinikum</name>
      <address>
        <city>Ulm</city>
        <state>Albert-Einstein-Allee 23</state>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum</name>
      <address>
        <city>Homburg/Saar</city>
        <state>Kirrberger Straße</state>
        <zip>66424</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Albers P, Wiegel T, Schmidberger H, Bussar-Maatz R, Harter M, Kristiansen G, Martus P, Meisner C, Wellek S, Grozinger K, Renner P, Burmester M, Schneider F, Stockle M. Termination rates and histological reclassification of active surveillance patients with low- and early intermediate-risk prostate cancer: results of the PREFERE trial. World J Urol. 2021 Jan;39(1):65-72. doi: 10.1007/s00345-020-03154-7. Epub 2020 Mar 18.</citation>
    <PMID>32189088</PMID>
  </results_reference>
  <results_reference>
    <citation>Wiegel T, Albers P, Bartkowiak D, Bussar-Maatz R, Harter M, Kristiansen G, Martus P, Wellek S, Schmidberger H, Grozinger K, Renner P, Schneider F, Burmester M, Stockle M. Results of a randomized trial of treatment modalities in patients with low or early-intermediate risk prostate cancer (PREFERE trial). J Cancer Res Clin Oncol. 2021 Jan;147(1):235-242. doi: 10.1007/s00432-020-03327-2. Epub 2020 Sep 4. Erratum In: J Cancer Res Clin Oncol. 2020 Dec 21;:</citation>
    <PMID>32886212</PMID>
  </results_reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</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/NCT01717677
org study id: AP 65/11
secondary id: DRKS00004405
nct id: NCT01717677
lead sponsor: 
has dmc: Yes
4arms preference based Study to compare four therapy options in prostate cancer with low or
      early intermediate risk
The study will compare four possible therapy options for treatment of newly diagnosed
      prostate cancer with low or "early intermediate" risk according to the patients preferences.

      The Following hypotheses will be tested:

        -  Radiation is not relevantly worse compared to prostatectomy with regard to time to
           prostate cancer-related deaths

        -  Permanent seed implantation therapy not inferior to prostatectomy with regard to time to
           prostate cancer-related deaths.

        -  Active Surveillance does not lead to a significant decrease of time to prostate
           cancer-related deaths compared to prostatectomy.

      That for patients with newly diagnosed prostate cancer will be randomized into one of the
      four treatment arms. Randomization may be limited to at least two of the four treatment arms
      if a patient refuses one or two of the four treatment arms according to his own preference.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Prostate cancer-specific survival
time frame: minimal observation time of 13 years for last study patient
measure: - Overall survival
time frame: minimal observation time of 13 years for last study patient
measure: - Time to onset of hormone therapy
time frame: 17 years
measure: - Occurrence of the first progression on hormone therapy
time frame: 17 years
measure: - Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at baseline
time frame: before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years
measure: - Complications / Safety
time frame: median 15 years
arm group label: radical prostatectomy
arm group type: Experimental
description: Procedure/Surgery: radical prostatectomy
arm group label: percutaneous radiation therapy
arm group type: Experimental
description: Radiation: percutaneous radiation therapy
arm group label: permanent seed implantation
arm group type: Experimental
description: Radiation: permanent seed implantation
arm group label: Active Surveillance
arm group type: Experimental
description: Procedure/Surgery: Active Surveillance
intervention type: Procedure
intervention name: radical prostatectomy
arm group label: radical prostatectomy
intervention type: Radiation
intervention name: percutaneous radiation therapy
arm group label: percutaneous radiation therapy
intervention type: Radiation
intervention name: permanent seed implantation
arm group label: permanent seed implantation
intervention type: Procedure
intervention name: Active Surveillance
arm group label: Active Surveillance
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Michael Stöckle, Prof. Dr.
role: Principal Investigator
affiliation: Klinik für Urologie und Kinderurologie der Universität des Saarlandes
last name: Thomas Wiegel, Prof. Dr.
role: Principal Investigator
affiliation: Klinik für Strahlentherapie und Radioonkologie der Universität Ulm
facility: 
facility: 
country: Germany
citation: Albers P, Wiegel T, Schmidberger H, Bussar-Maatz R, Harter M, Kristiansen G, Martus P, Meisner C, Wellek S, Grozinger K, Renner P, Burmester M, Schneider F, Stockle M. Termination rates and histological reclassification of active surveillance patients with low- and early intermediate-risk prostate cancer: results of the PREFERE trial. World J Urol. 2021 Jan;39(1):65-72. doi: 10.1007/s00345-020-03154-7. Epub 2020 Mar 18.
PMID: 32189088
citation: Wiegel T, Albers P, Bartkowiak D, Bussar-Maatz R, Harter M, Kristiansen G, Martus P, Wellek S, Schmidberger H, Grozinger K, Renner P, Schneider F, Burmester M, Stockle M. Results of a randomized trial of treatment modalities in patients with low or early-intermediate risk prostate cancer (PREFERE trial). J Cancer Res Clin Oncol. 2021 Jan;147(1):235-242. doi: 10.1007/s00432-020-03327-2. Epub 2020 Sep 4. Erratum In: J Cancer Res Clin Oncol. 2020 Dec 21;:
PMID: 32886212
responsible party type: Sponsor
mesh term: Prostatic Neoplasms