<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/NCT03301701</url>
  </required_header>
  <id_info>
    <org_study_id>PRORAD</org_study_id>
    <nct_id>NCT03301701</nct_id>
  </id_info>
  <brief_title>Feasibility Trial in Men With Hormone Sensitive Oligometastatic Prostate Cancer</brief_title>
  <acronym>PRORAD</acronym>
  <official_title>Randomized Feasibility Trial of Prostate Radiotherapy vs Prostatectomy in Men With Hormone Sensitive Oligometastatic Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Patrick Cheung</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</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>
      Patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours&#xD;
      outside of regional pelvic nodes with no more than 3 in any organ system) and no previous&#xD;
      treatment to prostate will be treated with intermittent androgen deprivation therapy +/-&#xD;
      chemotherapy, stereotactic radiotherapy to all metastases, and either radical prostatectomy&#xD;
      or radiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators propose to do a randomized feasibility trial comparing RP vs RT to the prostate&#xD;
      in the setting of hormone sensitive oligometastatic prostate cancer. SBRT will be used to&#xD;
      treat all of the metastases, and this will be combined with an intermittent ADT approach.&#xD;
      Adding systemic chemotherapy will be allowed. Given the past difficulties of randomizing&#xD;
      patients between RP and RT in localized prostate cancer studies (like SPIRIT), investigators&#xD;
      feel a small feasibility project is the first step. In the setting of metastatic disease,&#xD;
      where radical treatment is not routine standard of care, we hope that patients will be more&#xD;
      inclined to accept randomization. If patients do not accept their assigned randomization (ie&#xD;
      they prefer RP even though they are randomized to RT, or vice versa), they will still be&#xD;
      treated with their prostate intervention of choice and followed for their outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of accruals&#xD;
  </why_stopped>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">May 30, 2019</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>Patients willing to accept their randomization</measure>
    <time_frame>2 years</time_frame>
    <description>Patients willing to accept their randomization will be measured as a proportion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Toxicity</measure>
    <time_frame>7 years</time_frame>
    <description>Acute and late toxicities will be measured using CTCAE v4.0 and will be reported as percentages.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>7 years</time_frame>
    <description>Time to CRPC will be calculated using Kaplan Meier methodology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>7 years</time_frame>
    <description>Progression free survival will be calculated using Kaplan Meier methodology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>7 years</time_frame>
    <description>Local control will be calculated using Kaplan Meier methodology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>7 years</time_frame>
    <description>Distant control will be calculated using Kaplan Meier methodology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>7 years</time_frame>
    <description>Overall survival will be calculated using Kaplan Meier methodology.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hormone Sensitive Oligometastatic Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radical prostatectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Radiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radical prostatectomy</intervention_name>
    <description>Radical prostatectomy</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>HDR (19Gy) or SBRT (35-40Gy)</intervention_name>
    <description>Patients will receive HDR unless judged to medically unfit to undergo HDR brachytherapy, in which case they will receive SBRT</description>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide informed consent.&#xD;
&#xD;
          -  Histologic confirmation of prostate adenocarcinoma.&#xD;
&#xD;
          -  Stage IV disease with ≤ 5 metastases outside of the pelvis.&#xD;
&#xD;
          -  ≤ 3 metastases in any one organ system.&#xD;
&#xD;
          -  ECOG performance 0-1.&#xD;
&#xD;
          -  All metastatic tumours amenable to SBRT.&#xD;
&#xD;
          -  Patient eligible for either RP or RT to the prostate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Castration resistant prostate cancer.&#xD;
&#xD;
          -  Previous RP or RT to prostate.&#xD;
&#xD;
          -  Inability to treat all metastases with SBRT.&#xD;
&#xD;
          -  Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, in-situ&#xD;
             cancer, superficial bladder cancer, chronic lymphocytic leukemia or low grade lymphoma&#xD;
             which is being observed.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Cheung</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>November 26, 2020</last_update_submitted>
  <last_update_submitted_qc>November 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Dr. Patrick Cheung</investigator_full_name>
    <investigator_title>Dr. Patrick Cheung</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT03301701
org study id: PRORAD
nct id: NCT03301701
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours
      outside of regional pelvic nodes with no more than 3 in any organ system) and no previous
      treatment to prostate will be treated with intermittent androgen deprivation therapy +/-
      chemotherapy, stereotactic radiotherapy to all metastases, and either radical prostatectomy
      or radiotherapy.
Investigators propose to do a randomized feasibility trial comparing RP vs RT to the prostate
      in the setting of hormone sensitive oligometastatic prostate cancer. SBRT will be used to
      treat all of the metastases, and this will be combined with an intermittent ADT approach.
      Adding systemic chemotherapy will be allowed. Given the past difficulties of randomizing
      patients between RP and RT in localized prostate cancer studies (like SPIRIT), investigators
      feel a small feasibility project is the first step. In the setting of metastatic disease,
      where radical treatment is not routine standard of care, we hope that patients will be more
      inclined to accept randomization. If patients do not accept their assigned randomization (ie
      they prefer RP even though they are randomized to RT, or vice versa), they will still be
      treated with their prostate intervention of choice and followed for their outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patients willing to accept their randomization
time frame: 2 years
description: Patients willing to accept their randomization will be measured as a proportion.
measure: Toxicity
time frame: 7 years
description: Acute and late toxicities will be measured using CTCAE v4.0 and will be reported as percentages.
measure: Efficacy
time frame: 7 years
description: Time to CRPC will be calculated using Kaplan Meier methodology.
measure: Efficacy
time frame: 7 years
description: Progression free survival will be calculated using Kaplan Meier methodology.
measure: Efficacy
time frame: 7 years
description: Local control will be calculated using Kaplan Meier methodology.
measure: Efficacy
time frame: 7 years
description: Distant control will be calculated using Kaplan Meier methodology.
measure: Efficacy
time frame: 7 years
description: Overall survival will be calculated using Kaplan Meier methodology.
arm group label: Arm 1
arm group type: Experimental
description: Radical prostatectomy
arm group label: Arm 2
arm group type: Active Comparator
description: Radiotherapy
intervention type: Procedure
intervention name: Radical prostatectomy
description: Radical prostatectomy
arm group label: Arm 1
intervention type: Radiation
intervention name: HDR (19Gy) or SBRT (35-40Gy)
description: Patients will receive HDR unless judged to medically unfit to undergo HDR brachytherapy, in which case they will receive SBRT
arm group label: Arm 2
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick Cheung
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Dr. Patrick Cheung
investigator title: Dr. Patrick Cheung
mesh term: Prostatic Neoplasms
mesh term: Hypersensitivity
sharing ipd: No