<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/NCT04422132</url>
  </required_header>
  <id_info>
    <org_study_id>20-03021572</org_study_id>
    <nct_id>NCT04422132</nct_id>
  </id_info>
  <brief_title>Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks</brief_title>
  <official_title>Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Viewray Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare urinary and bowel side effects of hypofractionated&#xD;
      radiotherapy in 20 treatments (4 weeks) to ultra-hypofractionated radiotherapy in 5&#xD;
      treatments (2 weeks) for prostate cancer that has returned after prostatectomy. The&#xD;
      investigators are also interested in looking at time to progression and the quality of life&#xD;
      (health scores).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The standard treatment for most patients with biochemical recurrence after radical&#xD;
      prostatectomy is salvage radiotherapy. Salvage radiotherapy delays the need for chronic,&#xD;
      non-curative treatment, such as long-term androgen suppression, and is the only potentially&#xD;
      curative treatment of some biochemical recurrences after prostatectomy.&#xD;
&#xD;
      Patients are recommended to undergo salvage radiotherapy to eradicate biochemical disease&#xD;
      delivered in approximately 40 treatments over the course of 8 weeks, representing a high&#xD;
      burden of therapy, which may be related to lower utilization of salvage radiotherapy. Modern&#xD;
      radiotherapy for prostate cancer has been afforded many advantages including advanced&#xD;
      image-guided radiotherapy allowing for larger dose delivery in fewer treatments and smaller&#xD;
      margins with hypofractionated (20 treatments) and ultra-hypofractionated (5 treatments)&#xD;
      radiotherapy.&#xD;
&#xD;
      In patients that need salvage radiotherapy, the potential advantages of hypofractionated and&#xD;
      ultra-hypofractionated radiotherapy delivered over 20 or 5 treatments are: 1) increased&#xD;
      convenience to patients because of fewer treatment days, 2) reduced costs to patients because&#xD;
      of reduced travel expenses and copays, 3) improved resource utilization for physicians&#xD;
      because of the fewer number of treatments per patient and consequently 4) reduced cost to&#xD;
      society. In prostate cancer specifically, hypofractionated and ultra-hypofractionated&#xD;
      radiotherapy has the added potential of not increasing toxicity with shorter treatment times.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 24, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Phase 2</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>Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)</measure>
    <time_frame>Baseline, 1 month, 24 months</time_frame>
    <description>The primary objective is to demonstrate that 5 days of ultra-hypofractionated radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms over 20 days of hypofractionated radiotherapy 2 years after treatment completion as measured by EPIC.&#xD;
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the number of patient reported GI-GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)</measure>
    <time_frame>3 months, 6 months, 12 months, 24 months, 60 months</time_frame>
    <description>Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.&#xD;
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.&#xD;
Adverse events can be unexpected or expected, related to treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression (TTP)</measure>
    <time_frame>3 months, 6 months, 12 months, 24 months, 60 months</time_frame>
    <description>Compare time to progression (TTP) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (PCSM).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>3 months, 6 months, 12 months, 24 months, 60 months</time_frame>
    <description>Overall survival (OS) will be measured among the participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who expired due to prostate cancer.</measure>
    <time_frame>Through study completion, an average of 10 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">134</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>ARM 1 - 2 weeks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive treatment to the prostate fossa +/- nodes in 32.5 Gy in 5 fractions. Patients receiving 32.5 Gy in 5 fractions cannot be treated on consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM 2 - 4 weeks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive treatment to the prostate fossa +/- nodes in 55 Gy in 20 fractions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>5 days Radiation Therapy (32.5 Gy in 5 fractions)</intervention_name>
    <description>Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.</description>
    <arm_group_label>ARM 1 - 2 weeks</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>20 days Radiation therapy (55 Gy in 20 fractions)</intervention_name>
    <description>Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.</description>
    <arm_group_label>ARM 2 - 4 weeks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men aged 18 and older with histologically confirmed prostate cancer after&#xD;
             prostatectomy with detectable PSA. PSA does not need to be detectable for men with&#xD;
             pathologically node positive disease.&#xD;
&#xD;
          -  KPS &gt;=70&#xD;
&#xD;
          -  Patient with no evidence of distant metastatic disease on PET/CT/MRI or bone scan &lt; 9&#xD;
             months prior to enrollment. Patients with positive pelvic lymph nodes are eligible.&#xD;
&#xD;
          -  Ability to receive MRI-guided radiotherapy.&#xD;
&#xD;
          -  Equivocal evidence of metastatic disease outside the pelvis on standard imaging&#xD;
             requires documented negative biopsy.&#xD;
&#xD;
          -  Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of receiving pelvic radiotherapy.&#xD;
&#xD;
          -  Patient with inflammatory bowel disease.&#xD;
&#xD;
          -  Patients with a prior or concurrent malignancy whose natural history or treatment has&#xD;
             the potential to interfere with the safety or efficacy assessment of&#xD;
             ultra-hypofractionated radiotherapy.&#xD;
&#xD;
          -  History of bladder neck or urethral stricture.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Himanshu Nagar, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sharanya Chandrasekhar, M.S.</last_name>
    <phone>646-962-2196</phone>
    <email>shc2043@med.cornell.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pragya Yadav, Ph.D.</last_name>
    <phone>646-962-2199</phone>
    <email>pry2003@med.cornell.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pragya Yadav, Ph.D.</last_name>
      <phone>646-962-2199</phone>
      <email>pry2003@med.cornell.edu</email>
    </contact>
    <contact_backup>
      <last_name>Charles Ekeh, M.D.</last_name>
      <phone>646-962-2196</phone>
      <email>che4005@med.cornell.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Himanshu Nagar, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://expl.ai/JUCWKDB</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</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>
  <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/NCT04422132
org study id: 20-03021572
nct id: NCT04422132
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to compare urinary and bowel side effects of hypofractionated
      radiotherapy in 20 treatments (4 weeks) to ultra-hypofractionated radiotherapy in 5
      treatments (2 weeks) for prostate cancer that has returned after prostatectomy. The
      investigators are also interested in looking at time to progression and the quality of life
      (health scores).
The standard treatment for most patients with biochemical recurrence after radical
      prostatectomy is salvage radiotherapy. Salvage radiotherapy delays the need for chronic,
      non-curative treatment, such as long-term androgen suppression, and is the only potentially
      curative treatment of some biochemical recurrences after prostatectomy.

      Patients are recommended to undergo salvage radiotherapy to eradicate biochemical disease
      delivered in approximately 40 treatments over the course of 8 weeks, representing a high
      burden of therapy, which may be related to lower utilization of salvage radiotherapy. Modern
      radiotherapy for prostate cancer has been afforded many advantages including advanced
      image-guided radiotherapy allowing for larger dose delivery in fewer treatments and smaller
      margins with hypofractionated (20 treatments) and ultra-hypofractionated (5 treatments)
      radiotherapy.

      In patients that need salvage radiotherapy, the potential advantages of hypofractionated and
      ultra-hypofractionated radiotherapy delivered over 20 or 5 treatments are: 1) increased
      convenience to patients because of fewer treatment days, 2) reduced costs to patients because
      of reduced travel expenses and copays, 3) improved resource utilization for physicians
      because of the fewer number of treatments per patient and consequently 4) reduced cost to
      society. In prostate cancer specifically, hypofractionated and ultra-hypofractionated
      radiotherapy has the added potential of not increasing toxicity with shorter treatment times.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
time frame: Baseline, 1 month, 24 months
description: The primary objective is to demonstrate that 5 days of ultra-hypofractionated radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms over 20 days of hypofractionated radiotherapy 2 years after treatment completion as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
measure: Change in the number of patient reported GI-GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)
time frame: 3 months, 6 months, 12 months, 24 months, 60 months
description: Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Adverse events can be unexpected or expected, related to treatment.
measure: Time to progression (TTP)
time frame: 3 months, 6 months, 12 months, 24 months, 60 months
description: Compare time to progression (TTP) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (PCSM).
measure: Overall survival (OS)
time frame: 3 months, 6 months, 12 months, 24 months, 60 months
description: Overall survival (OS) will be measured among the participants
measure: Number of patients who expired due to prostate cancer.
time frame: Through study completion, an average of 10 years
arm group label: ARM 1 - 2 weeks
arm group type: Active Comparator
description: Patients will receive treatment to the prostate fossa +/- nodes in 32.5 Gy in 5 fractions. Patients receiving 32.5 Gy in 5 fractions cannot be treated on consecutive days.
arm group label: ARM 2 - 4 weeks
arm group type: Active Comparator
description: Patients will receive treatment to the prostate fossa +/- nodes in 55 Gy in 20 fractions.
intervention type: Radiation
intervention name: 5 days Radiation Therapy (32.5 Gy in 5 fractions)
description: Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.
arm group label: ARM 1 - 2 weeks
intervention type: Radiation
intervention name: 20 days Radiation therapy (55 Gy in 20 fractions)
description: Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.
arm group label: ARM 2 - 4 weeks
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Himanshu Nagar, M.D.
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: Sharanya Chandrasekhar, M.S.
phone: 646-962-2196
email: shc2043@med.cornell.edu
last name: Pragya Yadav, Ph.D.
phone: 646-962-2199
email: pry2003@med.cornell.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: https://expl.ai/JUCWKDB
description: Related Info
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No