<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/NCT04399824</url>
  </required_header>
  <id_info>
    <org_study_id>20-000051</org_study_id>
    <secondary_id>NCI-2020-01464</secondary_id>
    <secondary_id>20-000051</secondary_id>
    <nct_id>NCT04399824</nct_id>
  </id_info>
  <brief_title>Focal Radiation Therapy for the Treatment of Low or Intermediate-Risk Prostate Cancer</brief_title>
  <official_title>Focal Radiation Therapy (FRaT) Trial in Patients With Low/Intermediate-Risk Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonsson Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jonsson Comprehensive Cancer 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well focal radiation therapy with stereotactic body radiation&#xD;
      therapy (SBRT) or high-dose rate (HDR) brachytherapy works in treating patients with low or&#xD;
      intermediate-risk prostate cancer. Stereotactic body radiation therapy uses special equipment&#xD;
      to position a patient and deliver radiation to tumors with high precision. This method may&#xD;
      kill tumor cells with fewer doses over a shorter period and cause less damage to normal&#xD;
      tissue. Brachytherapy, also known as internal radiation therapy, uses radioactive material&#xD;
      placed directly into or near a tumor to kill tumor cells. HDR brachytherapy uses high doses&#xD;
      of radiation to target these tumor cells. Giving focal radiation therapy with SBRT or HDR&#xD;
      brachytherapy may target dominant tumor cells while sparing the reminder of the prostate or&#xD;
      surrounding normal organs and ultimately reduce side effects while maintaining disease&#xD;
      control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Evaluate biochemical progression free survival (bPFS) using the Phoenix definition.&#xD;
&#xD;
      II. Changes in quality of life. IIa. Prostate-Quality of Life (PR-QOL). IIb. Expanded&#xD;
      Prostate Cancer Index Composite (EPIC).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Prostate-specific antigen (PSA) response at 3, 6, 12, and 24 months. II. Clinical&#xD;
      progression free survival. IIa. Including phoenix definition, local progression by Response&#xD;
      Evaluation Criteria in Solid Tumors (RECIST), regional progression, distant metastasis, or&#xD;
      death.&#xD;
&#xD;
      III. Distant metastasis free survival. IV. Development of castration-resistant disease. V.&#xD;
      Overall survival.&#xD;
&#xD;
      OUTLINE: Patients are assigned to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients undergo SBRT in 5 fractions over 14 days in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
&#xD;
      ARM II: Patients undergo HDR brachytherapy on day 1 and a second fraction within 14 days in&#xD;
      the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for 6 weeks, every 3 months for&#xD;
      up to 24 months, every 6 months for up to 60 months, and then every 8-12 months until 120&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study did not open&#xD;
  </why_stopped>
  <start_date type="Actual">April 3, 2020</start_date>
  <completion_date type="Actual">April 3, 2020</completion_date>
  <primary_completion_date type="Actual">April 3, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemical progression free survival</measure>
    <time_frame>At 5 years</time_frame>
    <description>Will be assessed using the Phoenix definition and obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 120 months (10 years)</time_frame>
    <description>Will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0. Will be defined as the percentage of patients who encounter adverse events and calculated to indicate the toxicity level of focal radiation therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Baseline up to 120 months</time_frame>
    <description>Will be assessed using Prostate-Quality of Life and Expanded Prostate Cancer Index Composite. The change of the two scores will be assessed via two-sided paired t-test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prostate-specific antigen (PSA) response</measure>
    <time_frame>At 3, 6, 12, and 24 months</time_frame>
    <description>PSA response of each patient at 3, 6, 12, and 24 months will be collected and the PSA changes from baseline PSA to each time point will be evaluated via two-sided paired t-test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical progression free survival</measure>
    <time_frame>At 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis free survival</measure>
    <time_frame>At 5 years</time_frame>
    <description>Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of castration-resistant disease</measure>
    <time_frame>Up to 120 months (10 years)</time_frame>
    <description>Defined as clinical/biochemical progression of prostate cancer with testosterone &lt;40 ng/dl [nanograms (ng) per deciliter (dL)]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>At 5 years</time_frame>
    <description>Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Prostate Adenocarcinoma</condition>
  <condition>Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8</condition>
  <condition>Stage II Prostate Cancer AJCC v8</condition>
  <condition>Stage IIA Prostate Cancer AJCC v8</condition>
  <condition>Stage IIB Prostate Cancer AJCC v8</condition>
  <condition>Stage IIC Prostate Cancer AJCC v8</condition>
  <arm_group>
    <arm_group_label>Arm I (SBRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo SBRT in 5 fractions over 14 days in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (HDR brachytherapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo HDR brachytherapy on day 1 and a second fraction within 14 days in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>High-Dose Rate Brachytherapy</intervention_name>
    <description>Undergo HDR brachytherapy</description>
    <arm_group_label>Arm II (HDR brachytherapy)</arm_group_label>
    <other_name>Brachytherapy, High Dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (SBRT)</arm_group_label>
    <arm_group_label>Arm II (HDR brachytherapy)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (SBRT)</arm_group_label>
    <arm_group_label>Arm II (HDR brachytherapy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiation Therapy</intervention_name>
    <description>Undergo SBRT</description>
    <arm_group_label>Arm I (SBRT)</arm_group_label>
    <other_name>SABR</other_name>
    <other_name>SBRT</other_name>
    <other_name>Stereotactic Ablative Body Radiation Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to&#xD;
             registration via systematic biopsy and with the following low/intermediate-risk&#xD;
             features:&#xD;
&#xD;
               -  cT1c - T2b&#xD;
&#xD;
               -  PSA =&lt; 15&#xD;
&#xD;
               -  &lt; 50% cores positive&#xD;
&#xD;
               -  Gleason score (GS) =&lt; 7 (3+4 and 4+3 included)&#xD;
&#xD;
          -  Multiparametric magnetic resonance imaging (MRI) (mp-MRI) confirmed lesion(s) with&#xD;
             only one lobe involvement of the prostate&#xD;
&#xD;
          -  Unilateral disease on systematic biopsy&#xD;
&#xD;
          -  No distant or locally advanced disease on standard staging exams as indicated&#xD;
&#xD;
               -  Bone scan and abdominopelvic computed tomography (CT)/MRI OR&#xD;
&#xD;
               -  Prostate specific membrane antigen (PSMA) positron emission tomography (PET)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days&#xD;
             prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gleason score &gt;= 8&#xD;
&#xD;
          -  Gross extracapsular extension&#xD;
&#xD;
          -  Seminal vesicle invasion&#xD;
&#xD;
          -  Radiographic nodal or distant metastatic disease&#xD;
&#xD;
          -  Androgen deprivation therapy within 90 days of enrollment&#xD;
&#xD;
          -  Lesion(s) comprising &gt; 40% of total prostate volume&#xD;
&#xD;
          -  Lesion &lt; 0.5 cm from urethra&#xD;
&#xD;
          -  Prior radical prostatectomy&#xD;
&#xD;
          -  Prior radiotherapy to the pelvis&#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>Alan C Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA / Jonsson Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA / Jonsson Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>March 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2020</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>
  <!-- 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/NCT04399824
org study id: 20-000051
secondary id: NCI-2020-01464
secondary id: 20-000051
nct id: NCT04399824
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This phase II trial studies how well focal radiation therapy with stereotactic body radiation
      therapy (SBRT) or high-dose rate (HDR) brachytherapy works in treating patients with low or
      intermediate-risk prostate cancer. Stereotactic body radiation therapy uses special equipment
      to position a patient and deliver radiation to tumors with high precision. This method may
      kill tumor cells with fewer doses over a shorter period and cause less damage to normal
      tissue. Brachytherapy, also known as internal radiation therapy, uses radioactive material
      placed directly into or near a tumor to kill tumor cells. HDR brachytherapy uses high doses
      of radiation to target these tumor cells. Giving focal radiation therapy with SBRT or HDR
      brachytherapy may target dominant tumor cells while sparing the reminder of the prostate or
      surrounding normal organs and ultimately reduce side effects while maintaining disease
      control.
PRIMARY OBJECTIVES:

      I. Evaluate biochemical progression free survival (bPFS) using the Phoenix definition.

      II. Changes in quality of life. IIa. Prostate-Quality of Life (PR-QOL). IIb. Expanded
      Prostate Cancer Index Composite (EPIC).

      SECONDARY OBJECTIVES:

      I. Prostate-specific antigen (PSA) response at 3, 6, 12, and 24 months. II. Clinical
      progression free survival. IIa. Including phoenix definition, local progression by Response
      Evaluation Criteria in Solid Tumors (RECIST), regional progression, distant metastasis, or
      death.

      III. Distant metastasis free survival. IV. Development of castration-resistant disease. V.
      Overall survival.

      OUTLINE: Patients are assigned to 1 of 2 arms.

      ARM I: Patients undergo SBRT in 5 fractions over 14 days in the absence of disease
      progression or unacceptable toxicity.

      ARM II: Patients undergo HDR brachytherapy on day 1 and a second fraction within 14 days in
      the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 6 weeks, every 3 months for
      up to 24 months, every 6 months for up to 60 months, and then every 8-12 months until 120
      months.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Biochemical progression free survival
time frame: At 5 years
description: Will be assessed using the Phoenix definition and obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.
measure: Incidence of adverse events
time frame: Up to 120 months (10 years)
description: Will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0. Will be defined as the percentage of patients who encounter adverse events and calculated to indicate the toxicity level of focal radiation therapy.
measure: Change in quality of life
time frame: Baseline up to 120 months
description: Will be assessed using Prostate-Quality of Life and Expanded Prostate Cancer Index Composite. The change of the two scores will be assessed via two-sided paired t-test.
measure: Prostate-specific antigen (PSA) response
time frame: At 3, 6, 12, and 24 months
description: PSA response of each patient at 3, 6, 12, and 24 months will be collected and the PSA changes from baseline PSA to each time point will be evaluated via two-sided paired t-test.
measure: Clinical progression free survival
time frame: At 5 years
measure: Distant metastasis free survival
time frame: At 5 years
description: Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.
measure: Development of castration-resistant disease
time frame: Up to 120 months (10 years)
description: Defined as clinical/biochemical progression of prostate cancer with testosterone <40 ng/dl [nanograms (ng) per deciliter (dL)]
measure: Overall survival
time frame: At 5 years
description: Will be obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.
arm group label: Arm I (SBRT)
arm group type: Experimental
description: Patients undergo SBRT in 5 fractions over 14 days in the absence of disease progression or unacceptable toxicity.
arm group label: Arm II (HDR brachytherapy)
arm group type: Experimental
description: Patients undergo HDR brachytherapy on day 1 and a second fraction within 14 days in the absence of disease progression or unacceptable toxicity.
intervention type: Radiation
intervention name: High-Dose Rate Brachytherapy
description: Undergo HDR brachytherapy
arm group label: Arm II (HDR brachytherapy)
other name: Brachytherapy, High Dose
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm I (SBRT)
arm group label: Arm II (HDR brachytherapy)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (SBRT)
arm group label: Arm II (HDR brachytherapy)
intervention type: Radiation
intervention name: Stereotactic Body Radiation Therapy
description: Undergo SBRT
arm group label: Arm I (SBRT)
other name: SABR
other name: SBRT
other name: Stereotactic Ablative Body Radiation Therapy
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alan C Lee
role: Principal Investigator
affiliation: UCLA / Jonsson Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms