<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/NCT03269422</url>
  </required_header>
  <id_info>
    <org_study_id>17-407</org_study_id>
    <nct_id>NCT03269422</nct_id>
  </id_info>
  <brief_title>Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)</brief_title>
  <official_title>A Phase I Feasibility Study of Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR Image-Guided, Intensity-Modulated Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated&#xD;
      radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate&#xD;
      risk prostrate cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Anticipated">August 28, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 28, 2024</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>Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity</measure>
    <time_frame>36 months</time_frame>
    <description>Assess toxicity of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostate cancer. Severe Toxicity will be assessed and defined as Grade 3 or higher NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>MR Image Guided, Intensity-Modulated Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients enrolled in this study will undergo MR-based, image-guided, intensity-modulated radiotherapy using similar equipment, techniques, and treatment-planning procedures as currently practiced at MSKCC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>MR-based image-guided, intensity-modulated radiotherapy</intervention_name>
    <description>Patients will receive a standard dose of 8 Gy/fraction for five fractions for a total dose of 40 Gy to the prostate with a simultaneously delivered boost of 9 Gy for five fractions (clinically non-standard dose of 45 Gy total) to a single dominant lesion with a maximum dimension of at least 0.5 cm as determined on pre-treatment diagnostic T2 MRI imaging.</description>
    <arm_group_label>MR Image Guided, Intensity-Modulated Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intermediate risk prostate cancer patients will be eligible for this study. Risk&#xD;
             groups will be assigned as per NCCN guidelines. Intermediate risk patients will be&#xD;
             defined as:&#xD;
&#xD;
               -  PSA 10-20 ng/ml or&#xD;
&#xD;
               -  Gleason score = 7 or&#xD;
&#xD;
               -  Clinical stage T2b/T2c&#xD;
&#xD;
          -  Additionally, patients will be required to meet the following criteria:&#xD;
&#xD;
               -  Age &gt;18&#xD;
&#xD;
               -  KPS &gt; 80&#xD;
&#xD;
               -  Prostate size &lt; 60cc&#xD;
&#xD;
               -  Presence of a prostatic lesion with maximum dimension of &gt;/= 0.5cm and no more&#xD;
                  than two additional disease foci, each with a maximum dimension less than that of&#xD;
                  the dominant lesion.&#xD;
&#xD;
               -  International Prostrate Symptom Score &lt; 15&#xD;
&#xD;
               -  Subjects must fill out the standard MRI screening form and satisfy all MRI&#xD;
                  screening criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior androgen deprivation therapy for prostate cancer&#xD;
&#xD;
          -  Evidence of metastatic disease on bone scan or MRI/CT&#xD;
&#xD;
          -  MRI ineligibility due to the presence of a cardiac pacemaker, defibrillator or other&#xD;
             implanted metallic or electronic device which is considered MR unsafe, severe&#xD;
             claustrophobia or inability to lie flat for the duration of the study, etc.&#xD;
&#xD;
          -  Metallic hip implant, metallic implant or device in the pelvis that might distort the&#xD;
             local magnetic field and compromise quality of MP-MRI.&#xD;
&#xD;
          -  Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation&#xD;
             greater than 35 cm which are incompatible with MRCAT reconstruction&#xD;
&#xD;
          -  Contra-indications to receiving gadolinium contrast&#xD;
&#xD;
          -  KPS &lt; 80&#xD;
&#xD;
          -  Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease.&#xD;
&#xD;
          -  Prior history of transurethral resection of the prostate&#xD;
&#xD;
          -  Prior history of chronic prostatitis&#xD;
&#xD;
          -  Prior history of urethral stricture&#xD;
&#xD;
          -  Prior history of pelvic irradiation&#xD;
&#xD;
          -  History of inflammatory bowel disease&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Unable to complete quality of life questionnaires&#xD;
&#xD;
          -  Abnormal complete blood count. Any of the following&#xD;
&#xD;
               -  Platelet count less than 75,000/ml&#xD;
&#xD;
               -  Hb level less than 10 gm/dl&#xD;
&#xD;
               -  WBC less than 3.5/ml&#xD;
&#xD;
          -  Abnormal renal function tests (creatinine &gt; 1.5)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Gorovets, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge (Consent only and follow up)</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau (Consent and follow up)</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>17-407</keyword>
  <keyword>Intermediate Risk Prostate Cancer</keyword>
  <keyword>DIL</keyword>
  <keyword>Dominant Intra-Prostatic Lesion</keyword>
  <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>Undecided</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/NCT03269422
org study id: 17-407
nct id: NCT03269422
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated
      radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate
      risk prostrate cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
time frame: 36 months
description: Assess toxicity of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostate cancer. Severe Toxicity will be assessed and defined as Grade 3 or higher NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
arm group label: MR Image Guided, Intensity-Modulated Radiotherapy
arm group type: Experimental
description: Patients enrolled in this study will undergo MR-based, image-guided, intensity-modulated radiotherapy using similar equipment, techniques, and treatment-planning procedures as currently practiced at MSKCC.
intervention type: Radiation
intervention name: MR-based image-guided, intensity-modulated radiotherapy
description: Patients will receive a standard dose of 8 Gy/fraction for five fractions for a total dose of 40 Gy to the prostate with a simultaneously delivered boost of 9 Gy for five fractions (clinically non-standard dose of 45 Gy total) to a single dominant lesion with a maximum dimension of at least 0.5 cm as determined on pre-treatment diagnostic T2 MRI imaging.
arm group label: MR Image Guided, Intensity-Modulated Radiotherapy
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Gorovets, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.mskcc.org
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: Undecided