<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/NCT03778112</url>
  </required_header>
  <id_info>
    <org_study_id>mpMRI SBRT Prostate | 15060207</org_study_id>
    <secondary_id>15060207</secondary_id>
    <nct_id>NCT03778112</nct_id>
  </id_info>
  <brief_title>MRI Guided SBRT for Localized Prostate Cancer</brief_title>
  <official_title>Prospective Evaluation of Multi-Parametric MRI Guided Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush University Medical Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify&#xD;
      patients for two different radiotherapy regimens based on the presence/absence of&#xD;
      identifiable intraprostatic lesions.&#xD;
&#xD;
      In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions&#xD;
      (fractions) will be administered.&#xD;
&#xD;
      In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered&#xD;
      followed by an SBRT prostate boost while simultaneously treating the prostate cancer&#xD;
      lesion(s) to a higher dose in 3 fractions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiotherapy (RT) is considered standard of care treatment for prostate cancer. Conventional&#xD;
      RT regimens consist of 8-9 weeks of daily RT. Recent data support the use of hypofractionated&#xD;
      RT (5-6 weeks) due to similar disease control in a contracted treatment time. This study&#xD;
      combines the benefits of RT dose escalation while shortening the overall RT treatment course.&#xD;
&#xD;
      In this protocol, patients will undergo a pretreatment mpMRI prostate scan and be stratified&#xD;
      to two separate SBRT regimens depending on whether prostate lesions are present. For patients&#xD;
      without any positive mpMRI lesions, an SBRT monotherapy (36.25 Gy in 5 fractions) approach&#xD;
      will be utilized. Patients with an equivocal or positive mpMRI lesion(s), will receive&#xD;
      IG-IMRT (45 Gy in 25 fractions) to prostate and seminal vesicle +/- lymph nodes followed by a&#xD;
      SBRT whole prostate boost (18 Gy in 3 fractions) with a simultaneously integrated boost (SIB)&#xD;
      (21 Gy in 3 fractions) to intraprostatic lesion(s) only.&#xD;
&#xD;
      Patients will be regularly assessed every 3 months for the first 2 years and then every 6&#xD;
      months, indefinitely. Side effects will be monitored using the standardized international&#xD;
      prostate symptom score (I-PSS) and Sexual Health Inventory of Men (SHIM) questionnaires at&#xD;
      baseline and subsequent follow-up appointments.&#xD;
&#xD;
      Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk&#xD;
      prostate cancer nodules and deliver a higher effective RT dose, to achieve maximal tumor&#xD;
      control without increasing toxicity, all in a shortened treatment duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 23, 2016</start_date>
  <completion_date type="Anticipated">March 2029</completion_date>
  <primary_completion_date type="Actual">March 2019</primary_completion_date>
  <phase>N/A</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>Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity</measure>
    <time_frame>18 months</time_frame>
    <description>Number of Participants with late grade 3-5 genitourinary and gastrointestinal toxicity following mpMRI guided radiation treatment. Late toxicity will be defined as toxicity occurring more than nine months from the start of radiotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Acute Radiation Induced Genitourinary Adverse Event</measure>
    <time_frame>3 months</time_frame>
    <description>Adverse acute events are evaluated by the CTEP Active Version of the NCI CTCAE. The treatment-related attribution includes definitely, probably or possibly related to treatment. An acute adverse event is defined as the first occurrence of worst severity of the adverse event ≤30 days after the completion of RT. For each cohort, we will evaluate the acute radiation therapy-related adverse events. Specifically, we are interested in the percentage of acute GI and GU Grade 3+ adverse events that occur in each arm, which is considered to be similar to the high RT dose arm of RTOG 0126 in terms of RT dose. For this arm, a reported 1% of patients experienced Grade 3+ GI/GU acute toxicity, with no patient experiencing Grade 4 or 5 toxicities. If either hypofractionated arm has an acceptable percentage, then that arm will be deemed to have an acceptable adverse event profile. We will report the percentage for each arm as well as the one-sided 97.5% confidence interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical Recurrence</measure>
    <time_frame>18 months</time_frame>
    <description>Biochemical (PSA) recurrence is defined according to the proposed new Radiation Therapy Oncology Group/American Society for Therapeutic Radiology and Oncology (RTOG-ASTRO) criteria also known as the RTOG Phoenix definition: an increase of the PSA level at least 2 ng/mL greater than the minimum level reached after therapy (lowest PSA+ 2 criterion). PSA failure at 1, 2, and 5 years will be estimated for each cohort by the cumulative incidence method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Free-Survival</measure>
    <time_frame>18 months</time_frame>
    <description>The disease-free survival duration will be measured from the date of registration to the date of documentation of disease progression or until the date of death from any cause. DFS at 1, 2, and 5 years will be estimated for each c o h o r t by the Kaplan-Meier method. Also, 95% confidence intervals will be reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Negative mpMRI Prostate Scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SBRT to the whole prostate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Positive mpMRI Prostate Scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>SBRT to whole prostate</intervention_name>
    <description>Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate</description>
    <arm_group_label>Negative mpMRI Prostate Scan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions</intervention_name>
    <description>Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions</description>
    <arm_group_label>Positive mpMRI Prostate Scan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy proven prostate adenocarcinoma within 1 year of randomization&#xD;
&#xD;
          -  NCCN Low to High Risk localized prostate cancer&#xD;
&#xD;
          -  Zubrod Performance Status 0-1 within 60 days prior to registration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior or concurrent invasive malignancy (except non-melanoma skin cancer)&#xD;
&#xD;
          -  Regional Lymph Node (N1) involvement&#xD;
&#xD;
          -  Distant Metastases (M1) involvement&#xD;
&#xD;
          -  History of prior pelvic irradiation (external beam radiotherapy or brachytherapy)&#xD;
&#xD;
          -  Prior chemotherapy&#xD;
&#xD;
          -  Severe, active co-morbidities (unstable angina and/or CHF; MI; COPD; liver disease;&#xD;
             AIDS)&#xD;
&#xD;
          -  Acute bacterial or fungal infection requiring IV antibiotics&#xD;
&#xD;
          -  Inability to undergo MRI&#xD;
&#xD;
          -  Inability to receive fiducial markers&#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>Dian Wang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <results_first_submitted>November 2, 2022</results_first_submitted>
  <results_first_submitted_qc>February 8, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 14, 2023</results_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rush University Medical Center</investigator_affiliation>
    <investigator_full_name>Dian Wang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>SBRT</keyword>
  <keyword>Stereotactic Body Radiotherapy</keyword>
  <keyword>MRI</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>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03778112/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03778112/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Negative mpMRI Prostate Scan</title>
          <description>SBRT to the whole prostate&#xD;
SBRT to whole prostate: Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate</description>
        </group>
        <group group_id="P2">
          <title>Positive mpMRI Prostate Scan</title>
          <description>IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions&#xD;
IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions: Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Negative mpMRI Prostate Scan</title>
          <description>SBRT to the whole prostate&#xD;
SBRT to whole prostate: Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate</description>
        </group>
        <group group_id="B2">
          <title>Positive mpMRI Prostate Scan</title>
          <description>IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions&#xD;
IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions: Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="54"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity</title>
        <description>Number of Participants with late grade 3-5 genitourinary and gastrointestinal toxicity following mpMRI guided radiation treatment. Late toxicity will be defined as toxicity occurring more than nine months from the start of radiotherapy.</description>
        <time_frame>18 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Negative mpMRI Prostate Scan</title>
            <description>SBRT to the whole prostate&#xD;
SBRT to whole prostate: Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate</description>
          </group>
          <group group_id="O2">
            <title>Positive mpMRI Prostate Scan</title>
            <description>IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions&#xD;
IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions: Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity</title>
          <description>Number of Participants with late grade 3-5 genitourinary and gastrointestinal toxicity following mpMRI guided radiation treatment. Late toxicity will be defined as toxicity occurring more than nine months from the start of radiotherapy.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Acute Radiation Induced Genitourinary Adverse Event</title>
        <description>Adverse acute events are evaluated by the CTEP Active Version of the NCI CTCAE. The treatment-related attribution includes definitely, probably or possibly related to treatment. An acute adverse event is defined as the first occurrence of worst severity of the adverse event ≤30 days after the completion of RT. For each cohort, we will evaluate the acute radiation therapy-related adverse events. Specifically, we are interested in the percentage of acute GI and GU Grade 3+ adverse events that occur in each arm, which is considered to be similar to the high RT dose arm of RTOG 0126 in terms of RT dose. For this arm, a reported 1% of patients experienced Grade 3+ GI/GU acute toxicity, with no patient experiencing Grade 4 or 5 toxicities. If either hypofractionated arm has an acceptable percentage, then that arm will be deemed to have an acceptable adverse event profile. We will report the percentage for each arm as well as the one-sided 97.5% confidence interval.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Negative mpMRI Prostate Scan</title>
            <description>SBRT to the whole prostate&#xD;
SBRT to whole prostate: Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate</description>
          </group>
          <group group_id="O2">
            <title>Positive mpMRI Prostate Scan</title>
            <description>IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions&#xD;
IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions: Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Acute Radiation Induced Genitourinary Adverse Event</title>
          <description>Adverse acute events are evaluated by the CTEP Active Version of the NCI CTCAE. The treatment-related attribution includes definitely, probably or possibly related to treatment. An acute adverse event is defined as the first occurrence of worst severity of the adverse event ≤30 days after the completion of RT. For each cohort, we will evaluate the acute radiation therapy-related adverse events. Specifically, we are interested in the percentage of acute GI and GU Grade 3+ adverse events that occur in each arm, which is considered to be similar to the high RT dose arm of RTOG 0126 in terms of RT dose. For this arm, a reported 1% of patients experienced Grade 3+ GI/GU acute toxicity, with no patient experiencing Grade 4 or 5 toxicities. If either hypofractionated arm has an acceptable percentage, then that arm will be deemed to have an acceptable adverse event profile. We will report the percentage for each arm as well as the one-sided 97.5% confidence interval.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemical Recurrence</title>
        <description>Biochemical (PSA) recurrence is defined according to the proposed new Radiation Therapy Oncology Group/American Society for Therapeutic Radiology and Oncology (RTOG-ASTRO) criteria also known as the RTOG Phoenix definition: an increase of the PSA level at least 2 ng/mL greater than the minimum level reached after therapy (lowest PSA+ 2 criterion). PSA failure at 1, 2, and 5 years will be estimated for each cohort by the cumulative incidence method.</description>
        <time_frame>18 months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Free-Survival</title>
        <description>The disease-free survival duration will be measured from the date of registration to the date of documentation of disease progression or until the date of death from any cause. DFS at 1, 2, and 5 years will be estimated for each c o h o r t by the Kaplan-Meier method. Also, 95% confidence intervals will be reported.</description>
        <time_frame>18 months</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data collected up to 54 months from registration.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Negative mpMRI Prostate Scan</title>
          <description>SBRT to the whole prostate&#xD;
SBRT to whole prostate: Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate</description>
        </group>
        <group group_id="E2">
          <title>Positive mpMRI Prostate Scan</title>
          <description>IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions&#xD;
IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions: Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>NCI CTCAE version 4.</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Other acute/late grade 1-2 GI/GU event</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E2" events="48" subjects_affected="48" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>grade late GU toxicity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dian Wang, MD</name_or_title>
      <organization>Rush University Medical Center</organization>
      <phone>(708) 660-3476</phone>
      <email>Dian_Wang@rush.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03778112
org study id: mpMRI SBRT Prostate | 15060207
secondary id: 15060207
nct id: NCT03778112
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify
      patients for two different radiotherapy regimens based on the presence/absence of
      identifiable intraprostatic lesions.

      In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions
      (fractions) will be administered.

      In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered
      followed by an SBRT prostate boost while simultaneously treating the prostate cancer
      lesion(s) to a higher dose in 3 fractions.
Radiotherapy (RT) is considered standard of care treatment for prostate cancer. Conventional
      RT regimens consist of 8-9 weeks of daily RT. Recent data support the use of hypofractionated
      RT (5-6 weeks) due to similar disease control in a contracted treatment time. This study
      combines the benefits of RT dose escalation while shortening the overall RT treatment course.

      In this protocol, patients will undergo a pretreatment mpMRI prostate scan and be stratified
      to two separate SBRT regimens depending on whether prostate lesions are present. For patients
      without any positive mpMRI lesions, an SBRT monotherapy (36.25 Gy in 5 fractions) approach
      will be utilized. Patients with an equivocal or positive mpMRI lesion(s), will receive
      IG-IMRT (45 Gy in 25 fractions) to prostate and seminal vesicle +/- lymph nodes followed by a
      SBRT whole prostate boost (18 Gy in 3 fractions) with a simultaneously integrated boost (SIB)
      (21 Gy in 3 fractions) to intraprostatic lesion(s) only.

      Patients will be regularly assessed every 3 months for the first 2 years and then every 6
      months, indefinitely. Side effects will be monitored using the standardized international
      prostate symptom score (I-PSS) and Sexual Health Inventory of Men (SHIM) questionnaires at
      baseline and subsequent follow-up appointments.

      Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk
      prostate cancer nodules and deliver a higher effective RT dose, to achieve maximal tumor
      control without increasing toxicity, all in a shortened treatment duration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity
time frame: 18 months
description: Number of Participants with late grade 3-5 genitourinary and gastrointestinal toxicity following mpMRI guided radiation treatment. Late toxicity will be defined as toxicity occurring more than nine months from the start of radiotherapy.
measure: Number of Participants With Acute Radiation Induced Genitourinary Adverse Event
time frame: 3 months
description: Adverse acute events are evaluated by the CTEP Active Version of the NCI CTCAE. The treatment-related attribution includes definitely, probably or possibly related to treatment. An acute adverse event is defined as the first occurrence of worst severity of the adverse event ≤30 days after the completion of RT. For each cohort, we will evaluate the acute radiation therapy-related adverse events. Specifically, we are interested in the percentage of acute GI and GU Grade 3+ adverse events that occur in each arm, which is considered to be similar to the high RT dose arm of RTOG 0126 in terms of RT dose. For this arm, a reported 1% of patients experienced Grade 3+ GI/GU acute toxicity, with no patient experiencing Grade 4 or 5 toxicities. If either hypofractionated arm has an acceptable percentage, then that arm will be deemed to have an acceptable adverse event profile. We will report the percentage for each arm as well as the one-sided 97.5% confidence interval.
measure: Biochemical Recurrence
time frame: 18 months
description: Biochemical (PSA) recurrence is defined according to the proposed new Radiation Therapy Oncology Group/American Society for Therapeutic Radiology and Oncology (RTOG-ASTRO) criteria also known as the RTOG Phoenix definition: an increase of the PSA level at least 2 ng/mL greater than the minimum level reached after therapy (lowest PSA+ 2 criterion). PSA failure at 1, 2, and 5 years will be estimated for each cohort by the cumulative incidence method.
measure: Disease Free-Survival
time frame: 18 months
description: The disease-free survival duration will be measured from the date of registration to the date of documentation of disease progression or until the date of death from any cause. DFS at 1, 2, and 5 years will be estimated for each c o h o r t by the Kaplan-Meier method. Also, 95% confidence intervals will be reported.
arm group label: Negative mpMRI Prostate Scan
arm group type: Experimental
description: SBRT to the whole prostate
arm group label: Positive mpMRI Prostate Scan
arm group type: Experimental
description: IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions
intervention type: Radiation
intervention name: SBRT to whole prostate
description: Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate
arm group label: Negative mpMRI Prostate Scan
intervention type: Radiation
intervention name: IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions
description: Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions
arm group label: Positive mpMRI Prostate Scan
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dian Wang, MD, PhD
role: Principal Investigator
affiliation: Rush University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rush University Medical Center
investigator full name: Dian Wang
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 