<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/NCT02229734</url>
  </required_header>
  <id_info>
    <org_study_id>FASTR-2</org_study_id>
    <nct_id>NCT02229734</nct_id>
  </id_info>
  <brief_title>Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2</brief_title>
  <acronym>FASTR-2</acronym>
  <official_title>Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will explore the combination of a stereotactic body radiation therapy (SBRT)&#xD;
      approach combined with one year of luteinizing hormone releasing hormone (LHRH) agonist for&#xD;
      older men with high risk prostate cancer, or men unwilling to undertake conventionally&#xD;
      fractionated therapy and three years of adjuvant hormone therapy.&#xD;
&#xD;
      The purpose of this study is to examine the safety of a shorter course of radiation treatment&#xD;
      combined wtih androgen deprivation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized controlled trials have established the improved efficacy (better biochemical&#xD;
      control and disease free survival) of combined radical radiation (70-80 Gy over 7-8 weeks)&#xD;
      combined with long term hormone therapy (2-3 years of adjuvant LHRH agonist) compared to a&#xD;
      primary hormone therapy or radiation therapy alone in men with locally advanced/high risk&#xD;
      disease. While this approach may be tolerable in fit individuals, this combination may not be&#xD;
      well tolerated by frail individuals, or those who live at a distance who may find it&#xD;
      difficult to attend for 7 weeks of radiation treatments. Those individuals with&#xD;
      co-morbidities such as diabetes, coronary artery disease or osteoporosis may have those&#xD;
      conditions exacerbated by long term hormone therapy.&#xD;
&#xD;
      The combination of short course radiation and hormone therapy was explored in the FASTR&#xD;
      trial. As part of the trial, patients received 12 months of hormone therapy with radiation&#xD;
      treatment to the pelvic lymph nodes (dose of 25 Gy in 5 fractions, 1 fraction per week)&#xD;
      concomitant with radiation treatment to the prostate (dose of 40 Gy in 5 fractions, 1&#xD;
      fraction per week). The study was discontinued due to toxicity. For the FASTR-2 study, these&#xD;
      concerns are being addressed through the use of a lower total dose to the prostate (35 Gy in&#xD;
      5 fractions, 1 fraction per week). Given the uncertainty of the benefit of pelvic nodal&#xD;
      radiation in prostate cancer, it was decided to omit the pelvic nodal radiation in the&#xD;
      FASTR-2 study. In addition, given the recent evidence supporting the equivalence of 18 months&#xD;
      of hormone therapy, compared to 36 months, it was decided to lengthen the duration of hormone&#xD;
      therapy in the FASTR-2 study to 18 months (versus 12 months in the FASTR study).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <phase>Phase 2</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>Genitourinary and Gastrointestinal Toxicity at 1 year</measure>
    <time_frame>Year 1 of follow-up</time_frame>
    <description>Genitourinary and gastrointestinal toxicity measured at year 1 of follow-up using the Common Toxicity Criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Free Survival at 3 years</measure>
    <time_frame>1, 2, and 3 years of follow-up</time_frame>
    <description>Defined by absence of clinical relapse and prostatic specific antigen (PSA) failure as per the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>1, 2, and 3 years of follow-up</time_frame>
    <description>Measured using the Prostate Cancer Radiotherapy questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genitourinary and Gastrointestinal Toxicity at 2 years</measure>
    <time_frame>Year 2 of follow-up</time_frame>
    <description>Genitourinary and gastrointestinal toxicity measured at year 2 of follow-up using the Common Toxicity Criteria&#xD;
Safety Issue? (FDAAA) Yes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genitourinary and gastrointestinal toxicity measured at 3 years</measure>
    <time_frame>Year 3 of follow-up</time_frame>
    <description>Genitourinary and gastrointestinal toxicity measured at year 3 of follow-up using the Common Toxicity Criteria</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Radiation plus Androgen Supression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiation plus Androgen Suppression give as stereotactic radiation 7gray (Gy) per week x 5 weeks and leuprolide 45mg every 6 months for 18 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation</intervention_name>
    <description>Radiation: Radiotherapy 7 gray (Gy) per week over 5 weeks (35Gy)</description>
    <arm_group_label>Radiation plus Androgen Supression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Androgen Suppression</intervention_name>
    <description>Leuprolide 45mg every 6 months for a total of 18 months</description>
    <arm_group_label>Radiation plus Androgen Supression</arm_group_label>
    <other_name>LHRH agonist</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  High risk prostate cancer&#xD;
&#xD;
          -  Has had multidisciplinary consultation with radiation oncologist and urologist&#xD;
&#xD;
          -  Age &gt;70 or refuses standard treatment&#xD;
&#xD;
          -  No evidence of extra-prostatic disease on screening bone scan and CT scan&#xD;
             (non-contrast CT used for CT simulation acceptable)&#xD;
&#xD;
          -  Signed written and voluntary informed consent provided.&#xD;
&#xD;
          -  Patients must be willing and able to comply with scheduled visits, treatment plan,&#xD;
             laboratory tests, and other study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not meeting the eligibility criteria&#xD;
&#xD;
          -  Prior pelvic radiotherapy or brachytherapy&#xD;
&#xD;
          -  Use of anti-coagulation (low molecular weight heparin or Coumadin)&#xD;
&#xD;
          -  History of inflammatory bowel disease, Crohn's disease, diverticulitis or collagen&#xD;
             vascular disease (other than rheumatoid arthritis)&#xD;
&#xD;
          -  Previous treatment for malignancy (other than basal or squamous cell skin cancer)&#xD;
             within 3 years of prostate cancer diagnosis&#xD;
&#xD;
          -  patients on androgen deprivation therapy &gt; 2 months prior to study enrolment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glenn Bauman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Regional Cancer Program of the Lawson Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Regional Cancer Program of the Lawson Health Research Institute</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/31681864/</url>
    <description>Preliminary Results and Toxicity Analysis</description>
  </link>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>June 1, 2021</last_update_submitted>
  <last_update_submitted_qc>June 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Glenn Bauman</investigator_full_name>
    <investigator_title>Principal Investigator</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Androgens</mesh_term>
  </intervention_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/NCT02229734
org study id: FASTR-2
nct id: NCT02229734
lead sponsor: 
has dmc: Yes
This study will explore the combination of a stereotactic body radiation therapy (SBRT)
      approach combined with one year of luteinizing hormone releasing hormone (LHRH) agonist for
      older men with high risk prostate cancer, or men unwilling to undertake conventionally
      fractionated therapy and three years of adjuvant hormone therapy.

      The purpose of this study is to examine the safety of a shorter course of radiation treatment
      combined wtih androgen deprivation therapy.
Randomized controlled trials have established the improved efficacy (better biochemical
      control and disease free survival) of combined radical radiation (70-80 Gy over 7-8 weeks)
      combined with long term hormone therapy (2-3 years of adjuvant LHRH agonist) compared to a
      primary hormone therapy or radiation therapy alone in men with locally advanced/high risk
      disease. While this approach may be tolerable in fit individuals, this combination may not be
      well tolerated by frail individuals, or those who live at a distance who may find it
      difficult to attend for 7 weeks of radiation treatments. Those individuals with
      co-morbidities such as diabetes, coronary artery disease or osteoporosis may have those
      conditions exacerbated by long term hormone therapy.

      The combination of short course radiation and hormone therapy was explored in the FASTR
      trial. As part of the trial, patients received 12 months of hormone therapy with radiation
      treatment to the pelvic lymph nodes (dose of 25 Gy in 5 fractions, 1 fraction per week)
      concomitant with radiation treatment to the prostate (dose of 40 Gy in 5 fractions, 1
      fraction per week). The study was discontinued due to toxicity. For the FASTR-2 study, these
      concerns are being addressed through the use of a lower total dose to the prostate (35 Gy in
      5 fractions, 1 fraction per week). Given the uncertainty of the benefit of pelvic nodal
      radiation in prostate cancer, it was decided to omit the pelvic nodal radiation in the
      FASTR-2 study. In addition, given the recent evidence supporting the equivalence of 18 months
      of hormone therapy, compared to 36 months, it was decided to lengthen the duration of hormone
      therapy in the FASTR-2 study to 18 months (versus 12 months in the FASTR study).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Genitourinary and Gastrointestinal Toxicity at 1 year
time frame: Year 1 of follow-up
description: Genitourinary and gastrointestinal toxicity measured at year 1 of follow-up using the Common Toxicity Criteria
measure: Disease Free Survival at 3 years
time frame: 1, 2, and 3 years of follow-up
description: Defined by absence of clinical relapse and prostatic specific antigen (PSA) failure as per the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition
measure: Quality of Life
time frame: 1, 2, and 3 years of follow-up
description: Measured using the Prostate Cancer Radiotherapy questionnaire
measure: Genitourinary and Gastrointestinal Toxicity at 2 years
time frame: Year 2 of follow-up
description: Genitourinary and gastrointestinal toxicity measured at year 2 of follow-up using the Common Toxicity Criteria
Safety Issue? (FDAAA) Yes
measure: Genitourinary and gastrointestinal toxicity measured at 3 years
time frame: Year 3 of follow-up
description: Genitourinary and gastrointestinal toxicity measured at year 3 of follow-up using the Common Toxicity Criteria
arm group label: Radiation plus Androgen Supression
arm group type: Experimental
description: Radiation plus Androgen Suppression give as stereotactic radiation 7gray (Gy) per week x 5 weeks and leuprolide 45mg every 6 months for 18 months
intervention type: Radiation
intervention name: Radiation
description: Radiation: Radiotherapy 7 gray (Gy) per week over 5 weeks (35Gy)
arm group label: Radiation plus Androgen Supression
intervention type: Drug
intervention name: Androgen Suppression
description: Leuprolide 45mg every 6 months for a total of 18 months
arm group label: Radiation plus Androgen Supression
other name: LHRH agonist
criteria: 
gender: Male
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Glenn Bauman, MD
role: Principal Investigator
affiliation: London Regional Cancer Program of the Lawson Health Research Institute
facility: 
country: Canada
url: https://pubmed.ncbi.nlm.nih.gov/31681864/
description: Preliminary Results and Toxicity Analysis
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Glenn Bauman
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
mesh term: Androgens