<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/NCT02220829</url>
  </required_header>
  <id_info>
    <org_study_id>PCS VII</org_study_id>
    <nct_id>NCT02220829</nct_id>
  </id_info>
  <brief_title>Comparative Study of Use of Alpha-Blockers to Treat Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy</brief_title>
  <official_title>Prophylactic Versus Therapeutic Alpha-Blockers in Prostate Cancer Patients Undergoing Radical Course Radiation Therapy ± HDR Boost. A GROUQ Phase III Randomized Clinical Trial (PCS-VII).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sir Mortimer B. Davis - Jewish General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sir Mortimer B. Davis - Jewish General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Approximately 50%-95% of prostate cancer patients undergoing radiation therapy (RT) develop&#xD;
      symptomatic urinary problems .These symptoms can significantly diminish a patient's quality&#xD;
      of life during and shortly after therapy. Alpha1-blockers, such as Rapaflo, act to decrease&#xD;
      resistance to urinary flow.&#xD;
&#xD;
      This multi-institutional phase III trial is designed to compare standard of care versus&#xD;
      preventive treatment with Rapaflo for prostate cancer patients, regardless of risk group,&#xD;
      whose treatment consists of radical radiation therapy. We plan to recruit 188 patients across&#xD;
      Quebec who will be randomized into two arms: rapaflo prescribed at start of radiation therapy&#xD;
      or if/when symptoms appear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The efficacy of Rapaflo treatment will be assessed using the International Prostate Symptom&#xD;
      Score (IPSS). The IPSS will be assessed at baseline before RT, 4 weeks into RT, the last day&#xD;
      of RT, and monthly thereafter for a total duration of 6 months from start of RT. Patients&#xD;
      will have 2 more IPSS assessments at 9 and 12 months. The total duration of follow-up will be&#xD;
      one year from start of RT. We will compare the rate of IPSS increase in the Rapaflo group&#xD;
      compared to the standard arm at different time point (4 weeks, 6 weeks and at the end of&#xD;
      treatment). We will also determine the rate of IPSS return to baseline at 4 and 12 weeks&#xD;
      after the end of treatment. The rate of therapy dependence in the 2 arms will be evaluated at&#xD;
      20 and 26 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Actual">June 2021</primary_completion_date>
  <phase>Phase 3</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the rate of increase and the mean difference from the baseline IPSS score in the alpha-blocker (Rapaflo) group compared to the standard arm.</measure>
    <time_frame>IPSS will be assessed before radiation therapy (RT), 4 weeks into RT, the last day of RT, and monthly for first 6 months and also at 9 and 12 months from the start of RT.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine the rate of IPSS return to baseline, in the alpha-blocker (Rapaflo) group compared to the standard after the end of radiation treatment.</measure>
    <time_frame>IPSS score will be assessed at before radiation therapy (RT), at 4 and 12 weeks after the end of RT.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the rate of therapy dependence in both groups.</measure>
    <time_frame>At 3 and 6 months from start of radiation therapy.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">188</enrollment>
  <condition>Urinary Problems</condition>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Preventive administration of Rapaflo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rapaflo treatment will start on day one of radiation therapy (early administration- before symptoms onset) and continue for a total duration of 6 months: 8 mg daily during 4 months and 8 mg every other day for 2 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Administration of alpha-blocker Rapaflo at the onset of symptomatic urinary problems caused by radiation therapy. 8 mg of Rapaflo is administered daily until disappearance of symptoms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Preventive administration of Rapaflo</intervention_name>
    <description>Rapaflo treatment: 8 mg daily during 4 months and 8 mg every other day for 2 months.</description>
    <arm_group_label>Preventive administration of Rapaflo</arm_group_label>
    <other_name>Rapaflo</other_name>
    <other_name>Silodosin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Administration of alpha-blocker Rapaflo only at onset of symptoms.</description>
    <arm_group_label>Standard care</arm_group_label>
    <other_name>Rapaflo</other_name>
    <other_name>Silodosin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult male 18 years of age or older&#xD;
&#xD;
          -  Patients with confirmed diagnosis of adenocarcinoma of the prostate.&#xD;
&#xD;
          -  The primary treatment should be external beam radiation therapy (EBRT) with or without&#xD;
             high dose rate (HDR) brachytherapy boost.&#xD;
&#xD;
          -  Clinical or radiological diagnosis of T1a - T3b.&#xD;
&#xD;
          -  No limitation with respect to Gleason score.&#xD;
&#xD;
          -  No limitation with respect to total Prostate-specific Antigen (PSA) value.&#xD;
&#xD;
          -  Karnofsky performance score (KPS) of ≥ 70.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Small cell cancer of the prostate&#xD;
&#xD;
          -  T4 disease, invading bladder or rectum.&#xD;
&#xD;
          -  Adjuvant or salvage radiation therapy&#xD;
&#xD;
          -  Brachy monotherapy&#xD;
&#xD;
          -  KPS &lt; 70&#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>Tamim Niazi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jewish General Hospital, McGill University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ashley Feng, M.Sc.</last_name>
    <phone>514-340-8222</phone>
    <phone_ext>26510</phone_ext>
    <email>yanqi.feng.ccomtl@ssss.gouv.qc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jewish General Hospital, McGill University</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashley Feng, M.Sc</last_name>
      <phone>514-340-8222</phone>
      <phone_ext>26510</phone_ext>
      <email>yanqi.feng.ccomtl@ssss.gouv.qc.ca</email>
    </contact>
    <investigator>
      <last_name>Tamim Niazi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Pollack A, Zagars GK, Starkschall G, Childress CH, Kopplin S, Boyer AL, Rosen II. Conventional vs. conformal radiotherapy for prostate cancer: preliminary results of dosimetry and acute toxicity. Int J Radiat Oncol Biol Phys. 1996 Feb 1;34(3):555-64. doi: 10.1016/0360-3016(95)02103-5.</citation>
    <PMID>8621278</PMID>
  </results_reference>
  <results_reference>
    <citation>Tsumura H, Satoh T, Ishiyama H, Tabata K, Kotani S, Minamida S, Kimura M, Fujita T, Matsumoto K, Kitano M, Hayakawa K, Baba S. Comparison of prophylactic naftopidil, tamsulosin, and silodosin for 125I brachytherapy-induced lower urinary tract symptoms in patients with prostate cancer: randomized controlled trial. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e385-92. doi: 10.1016/j.ijrobp.2011.04.026. Epub 2011 Jun 12.</citation>
    <PMID>21664068</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sir Mortimer B. Davis - Jewish General Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Tamim Niazi</investigator_full_name>
    <investigator_title>Radiation Oncologist</investigator_title>
  </responsible_party>
  <keyword>alpha-blocker</keyword>
  <keyword>symptomatic urinary problems</keyword>
  <keyword>radiation therapy</keyword>
  <keyword>prostate cancer</keyword>
  <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>Silodosin</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/NCT02220829
org study id: PCS VII
nct id: NCT02220829
lead sponsor: 
has dmc: No
Approximately 50%-95% of prostate cancer patients undergoing radiation therapy (RT) develop
      symptomatic urinary problems .These symptoms can significantly diminish a patient's quality
      of life during and shortly after therapy. Alpha1-blockers, such as Rapaflo, act to decrease
      resistance to urinary flow.

      This multi-institutional phase III trial is designed to compare standard of care versus
      preventive treatment with Rapaflo for prostate cancer patients, regardless of risk group,
      whose treatment consists of radical radiation therapy. We plan to recruit 188 patients across
      Quebec who will be randomized into two arms: rapaflo prescribed at start of radiation therapy
      or if/when symptoms appear.
The efficacy of Rapaflo treatment will be assessed using the International Prostate Symptom
      Score (IPSS). The IPSS will be assessed at baseline before RT, 4 weeks into RT, the last day
      of RT, and monthly thereafter for a total duration of 6 months from start of RT. Patients
      will have 2 more IPSS assessments at 9 and 12 months. The total duration of follow-up will be
      one year from start of RT. We will compare the rate of IPSS increase in the Rapaflo group
      compared to the standard arm at different time point (4 weeks, 6 weeks and at the end of
      treatment). We will also determine the rate of IPSS return to baseline at 4 and 12 weeks
      after the end of treatment. The rate of therapy dependence in the 2 arms will be evaluated at
      20 and 26 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: To determine the rate of increase and the mean difference from the baseline IPSS score in the alpha-blocker (Rapaflo) group compared to the standard arm.
time frame: IPSS will be assessed before radiation therapy (RT), 4 weeks into RT, the last day of RT, and monthly for first 6 months and also at 9 and 12 months from the start of RT.
measure: To determine the rate of IPSS return to baseline, in the alpha-blocker (Rapaflo) group compared to the standard after the end of radiation treatment.
time frame: IPSS score will be assessed at before radiation therapy (RT), at 4 and 12 weeks after the end of RT.
measure: To determine the rate of therapy dependence in both groups.
time frame: At 3 and 6 months from start of radiation therapy.
arm group label: Preventive administration of Rapaflo
arm group type: Active Comparator
description: Rapaflo treatment will start on day one of radiation therapy (early administration- before symptoms onset) and continue for a total duration of 6 months: 8 mg daily during 4 months and 8 mg every other day for 2 months.
arm group label: Standard care
arm group type: Other
description: Administration of alpha-blocker Rapaflo at the onset of symptomatic urinary problems caused by radiation therapy. 8 mg of Rapaflo is administered daily until disappearance of symptoms.
intervention type: Drug
intervention name: Preventive administration of Rapaflo
description: Rapaflo treatment: 8 mg daily during 4 months and 8 mg every other day for 2 months.
arm group label: Preventive administration of Rapaflo
other name: Rapaflo
other name: Silodosin
intervention type: Drug
intervention name: Standard Care
description: Administration of alpha-blocker Rapaflo only at onset of symptoms.
arm group label: Standard care
other name: Rapaflo
other name: Silodosin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tamim Niazi, MD
role: Principal Investigator
affiliation: Jewish General Hospital, McGill University
last name: Ashley Feng, M.Sc.
phone: 514-340-8222
phone ext: 26510
email: yanqi.feng.ccomtl@ssss.gouv.qc.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
citation: Pollack A, Zagars GK, Starkschall G, Childress CH, Kopplin S, Boyer AL, Rosen II. Conventional vs. conformal radiotherapy for prostate cancer: preliminary results of dosimetry and acute toxicity. Int J Radiat Oncol Biol Phys. 1996 Feb 1;34(3):555-64. doi: 10.1016/0360-3016(95)02103-5.
PMID: 8621278
citation: Tsumura H, Satoh T, Ishiyama H, Tabata K, Kotani S, Minamida S, Kimura M, Fujita T, Matsumoto K, Kitano M, Hayakawa K, Baba S. Comparison of prophylactic naftopidil, tamsulosin, and silodosin for 125I brachytherapy-induced lower urinary tract symptoms in patients with prostate cancer: randomized controlled trial. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e385-92. doi: 10.1016/j.ijrobp.2011.04.026. Epub 2011 Jun 12.
PMID: 21664068
responsible party type: Principal Investigator
investigator affiliation: Sir Mortimer B. Davis - Jewish General Hospital
investigator full name: Dr. Tamim Niazi
investigator title: Radiation Oncologist
mesh term: Prostatic Neoplasms
mesh term: Silodosin