<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/NCT01677845</url>
  </required_header>
  <id_info>
    <org_study_id>12-00867</org_study_id>
    <nct_id>NCT01677845</nct_id>
  </id_info>
  <brief_title>Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer</brief_title>
  <official_title>Phase I Study of Hypo-Fractionated Radiation Therapy (HRT) for Localized Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to determine the maximum tolerated dose of hypo-fractionated&#xD;
      radiation therapy and the toxicity of the treatment program.&#xD;
&#xD;
      Eligible patients with stage T1-2c prostate cancer who sign consent will be enrolled to this&#xD;
      phase I dose escalation trial and be treated with hypo-fractionated radiation therapy (HRT).&#xD;
      Dose escalation will be as follows:&#xD;
&#xD;
      There will be 3 cohorts consisting of 3 patients each.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dose escalation will be as follows:&#xD;
&#xD;
      There will be 3 cohorts consisting of 3 patients each. All patients will receive 18 fractions&#xD;
      of HRT over the course of 6 weeks (3 fractions per week). Dose level I will be 54Gy (3 Gy per&#xD;
      fraction), dose level II will be 55.8 Gy (3.1Gy per fraction), dose level III will be 57.6 Gy&#xD;
      (3.2 Gy per fraction). After accrual of dose level I, all patients will be observed for a&#xD;
      minimum of two weeks after completion of radiation treatments, for assessment of toxicity,&#xD;
      before the dose can be escalated for the next cohort. After dose level II, patients will be&#xD;
      observed for 6 months before enrolling patients on dose level III.&#xD;
&#xD;
      All patients will be seen weekly by their radiation oncologist during radiation therapy. Any&#xD;
      observations regarding radiation reactions will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI no longer with the institution&#xD;
  </why_stopped>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">August 25, 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>Phase 1</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>the maximum tolerated dose of HRT</measure>
    <time_frame>30 weeks</time_frame>
    <description>After accrual of dose level I, all patients will be observed for a minimum of two weeks after completion of radiation treatments, for assessment of toxicity, before the dose can be escalated for the next cohort. After dose level II, patients will be observed for 6 months before enrolling patients on dose level III.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Radiation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiation Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation</intervention_name>
    <description>Dose Level 1: 54 Gy; 3 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions;&#xD;
Dose Level 2: 55.8 Gy; 3.1 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions;&#xD;
Dose Level 3: 57.6 Gy; 3.2 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions.</description>
    <arm_group_label>Radiation Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History/physical examination with digital rectal examination of the prostate within 8&#xD;
             weeks prior to registration&#xD;
&#xD;
          -  Clinical stage T1-2c (AJCC 6th edition)&#xD;
&#xD;
          -  Gleason &lt;6 and PSA &lt;10 ng/mL&#xD;
&#xD;
          -  Gleason =7 and/or PSA 10-20 ng/mL provided &lt;34% of core biopsies are positive for&#xD;
             carcinoma&#xD;
&#xD;
          -  PSA &lt; 20 ng/mL within 180 days prior to registration. PSA should not be obtained for&#xD;
             at least 10 days after prostate biopsy.&#xD;
&#xD;
          -  Zubrod performance status 0-1&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  Patient must sign study specific informed consent prior to randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or&#xD;
             lymphomatous/hematogenous malignancy unless continually disease free for a minimum of&#xD;
             5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible)&#xD;
&#xD;
          -  Evidence of distant metastases&#xD;
&#xD;
          -  Regional lymph node involvement&#xD;
&#xD;
          -  Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer&#xD;
&#xD;
          -  Prior androgen deprivation therapy (ADT)&#xD;
&#xD;
          -  Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy&#xD;
&#xD;
          -  Previous or concurrent cytotoxic chemotherapy for prostate cancer&#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>Nicholas J Sanfilippo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Medical Center, Departement of Radiation Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Localized Prostate Cancer</keyword>
  <keyword>Radiation</keyword>
  <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/NCT01677845
org study id: 12-00867
nct id: NCT01677845
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine the maximum tolerated dose of hypo-fractionated
      radiation therapy and the toxicity of the treatment program.

      Eligible patients with stage T1-2c prostate cancer who sign consent will be enrolled to this
      phase I dose escalation trial and be treated with hypo-fractionated radiation therapy (HRT).
      Dose escalation will be as follows:

      There will be 3 cohorts consisting of 3 patients each.
Dose escalation will be as follows:

      There will be 3 cohorts consisting of 3 patients each. All patients will receive 18 fractions
      of HRT over the course of 6 weeks (3 fractions per week). Dose level I will be 54Gy (3 Gy per
      fraction), dose level II will be 55.8 Gy (3.1Gy per fraction), dose level III will be 57.6 Gy
      (3.2 Gy per fraction). After accrual of dose level I, all patients will be observed for a
      minimum of two weeks after completion of radiation treatments, for assessment of toxicity,
      before the dose can be escalated for the next cohort. After dose level II, patients will be
      observed for 6 months before enrolling patients on dose level III.

      All patients will be seen weekly by their radiation oncologist during radiation therapy. Any
      observations regarding radiation reactions will be recorded.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the maximum tolerated dose of HRT
time frame: 30 weeks
description: After accrual of dose level I, all patients will be observed for a minimum of two weeks after completion of radiation treatments, for assessment of toxicity, before the dose can be escalated for the next cohort. After dose level II, patients will be observed for 6 months before enrolling patients on dose level III.
arm group label: Radiation Therapy
arm group type: Experimental
description: Radiation Therapy
intervention type: Radiation
intervention name: Radiation
description: Dose Level 1: 54 Gy; 3 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions;
Dose Level 2: 55.8 Gy; 3.1 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions;
Dose Level 3: 57.6 Gy; 3.2 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions.
arm group label: Radiation Therapy
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicholas J Sanfilippo, MD
role: Principal Investigator
affiliation: NYU Langone Medical Center, Departement of Radiation Oncology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms