<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/NCT04465500</url>
  </required_header>
  <id_info>
    <org_study_id>HSR200113</org_study_id>
    <nct_id>NCT04465500</nct_id>
  </id_info>
  <brief_title>EBRT and HDR Brachytherapy for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer</brief_title>
  <acronym>Prostate005</acronym>
  <official_title>Prospective Trial of Combination External Beam Radiation Therapy and MRI-guided, Dose-differentiated High Dose-rate Prostate Brachytherapy Boost for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is trying to find out if the combination of Androgen deprivation therapy (ADT),&#xD;
      MRI guided high dose radiation (HDR) brachytherapy treatment (internal radiation implant&#xD;
      procedure) and external beam radiation therapy (EBRT) treatments lead to less side effects.&#xD;
      This study is also looking at patient outcomes, quality of life, and overall survival for&#xD;
      patients receiving this treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2029</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2027</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Androgen Deprivation Therapy (ADT) High-dose-rate (HDR) Brachytherapy External Beam Radiation Therapy (EBRT)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare GU toxicity rate to the rate published in the ASCENDE-RT trial</measure>
    <time_frame>2 years</time_frame>
    <description>Grade 3 GU toxicity rate as measured by CTCAE v5.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimate the prevalence of grade 3 or greater GU toxicity</measure>
    <time_frame>2 years</time_frame>
    <description>Greater than or equal to grade 3 GU toxicity rate as measured by CTCAE v5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate GI and sexual toxicity</measure>
    <time_frame>2 years</time_frame>
    <description>GI and sexual toxicity as measured by CTCAE v5.0 and EPIC-26 survey results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate freedom from biochemical failure (RFS)</measure>
    <time_frame>5 years</time_frame>
    <description>Prostate-specific antigen (PSA) failure (nadir greater than 2ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate rate of undetectable PSA levels</measure>
    <time_frame>5 years</time_frame>
    <description>PSA less than or equal to 0.2ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe impact of treatment on quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>EPIC-26 survey results</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Prostate Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>External Beam Radiation</intervention_name>
    <description>EBRT will be administered every 5 consecutive days for 5 consecutive weeks. This is standard of care practice for this therapy. This may be revised as applicable per treating physician discretion. The dose of radiation will be in accordance with standard clinical practice guidelines for the treatment of prostate cancer.</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>EBRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>HDR Brachytherapy</intervention_name>
    <description>HDR brachytherapy will be administered per standard clinical practice (per NCCN guidelines version 1.2020 for prostate cancer), however standard clinical practice may vary between clinicians. Therefore, the dose of 15Gy in 1 fraction and a set of dosimetry guidelines are to be followed for the purposes of this study. A diagnostic MRI will be co-registered with Transrectal Ultrasound (TRUS) to perform the HDR brachytherapy.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Androgen Deprivation Therapy</intervention_name>
    <description>The dosing and administration of ADT will be in accordance with the drug label for the drug(s) used for this purpose. Participants may receive ADT before and/or during the course of this study.</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>ADT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of signed and dated informed consent form.&#xD;
&#xD;
          2. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study.&#xD;
&#xD;
          3. Male, aged 18 or above.&#xD;
&#xD;
          4. Histologic proven diagnosis of cancer of the prostate up to one year before&#xD;
             registration.&#xD;
&#xD;
          5. Unfavorable-intermediate risk, high risk, or very high-risk prostate cancer as&#xD;
             determined by the NCCN Guidelines Version 4.2019 (Section 12.4).&#xD;
&#xD;
          6. History and physical exam completed up to 6 months before registration.&#xD;
&#xD;
          7. PSA value &lt; 50 ng/mL prior to androgen deprivation therapy and up to 12 months before&#xD;
             registration. Subjects who do not meet this criteria's timeframe due to extenuating&#xD;
             circumstances (i.e. COVID-19 quarantine, changes to their treatment plan, etc) but&#xD;
             meet all other eligibility criteria may still be eligible. The PI will review each&#xD;
             case and decide&#xD;
&#xD;
          8. ECOG performance status 0 or 1.&#xD;
&#xD;
          9. Pelvic MRI obtained up to 12 months before registration.&#xD;
&#xD;
         10. Candidate for receiving the combination of HDR brachytherapy and EBRT, with or without&#xD;
             ADT. The ADT may have begun prior to study enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of bone metastases.&#xD;
&#xD;
          2. Diagnosis of a prior invasive malignancy (except for non-melanoma skin cancer), unless&#xD;
             the participant has been disease-free for at least 3 years.&#xD;
&#xD;
          3. Patient has had previous radical surgery (prostatectomy) or cryosurgery for prostate&#xD;
             cancer.&#xD;
&#xD;
          4. Patient has had previous pelvic irradiation, prostate brachytherapy, or bilateral&#xD;
             orchiectomy.&#xD;
&#xD;
          5. Patient has had prior radiotherapy, including brachytherapy, to the region of this&#xD;
             study cancer that would result in overlap of radiation therapy fields.&#xD;
&#xD;
          6. Patient has had previous or concurrent cytotoxic chemotherapy for prostate cancer&#xD;
             (prior chemotherapy for different cancer is allowed).&#xD;
&#xD;
          7. Patient has MRI incompatible metallic implant(s) that cannot be removed.&#xD;
&#xD;
          8. The patient has severe or active co-morbidities as defined by the following:&#xD;
&#xD;
               -  Unstable angina and/or congestive heart failure requiring hospitalization up to 6&#xD;
                  months (180 days) before registration&#xD;
&#xD;
               -  Transmural myocardial infarction up to 6 months (180 days) before registration&#xD;
&#xD;
               -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time&#xD;
                  of registration&#xD;
&#xD;
               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness&#xD;
                  requiring hospitalization or precluding study therapy at the time of registration&#xD;
&#xD;
               -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation effects&#xD;
                  or severe liver dysfunction.&#xD;
&#xD;
               -  Acquired immune deficiency syndrome (AIDS) based upon current CDC definition. The&#xD;
                  need to exclude patients with AIDS from this protocol is necessary because the&#xD;
                  treatments involved in this protocol may be slightly immunosuppressive. Protocol-&#xD;
                  specific requirements may also exclude immuno-compromised patients.&#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>Chris Luminais, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Song Wood</last_name>
    <phone>434-243-0008</phone>
    <email>stw2g@uvahealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Song Wood</last_name>
      <phone>434-243-0008</phone>
      <email>stw2g@uvahealth.org</email>
    </contact>
    <investigator>
      <last_name>Chris Luminais, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Christopher Luminais, MD</investigator_full_name>
    <investigator_title>Assistant Professor of Radiation Oncology</investigator_title>
  </responsible_party>
  <keyword>Radiation</keyword>
  <keyword>Brachytherapy</keyword>
  <keyword>External beam radiation therapy</keyword>
  <keyword>Androgen Deprivation Therapy</keyword>
  <keyword>ADT</keyword>
  <keyword>EBRT</keyword>
  <keyword>HDR brachytherapy</keyword>
  <keyword>prostate cancer</keyword>
  <keyword>MRI guided brachytherapy</keyword>
  <keyword>brachytherapy boost</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Androgens</mesh_term>
  </intervention_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/NCT04465500
org study id: HSR200113
nct id: NCT04465500
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study is trying to find out if the combination of Androgen deprivation therapy (ADT),
      MRI guided high dose radiation (HDR) brachytherapy treatment (internal radiation implant
      procedure) and external beam radiation therapy (EBRT) treatments lead to less side effects.
      This study is also looking at patient outcomes, quality of life, and overall survival for
      patients receiving this treatment.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Androgen Deprivation Therapy (ADT) High-dose-rate (HDR) Brachytherapy External Beam Radiation Therapy (EBRT)
primary purpose: Treatment
masking: None (Open Label)
measure: Compare GU toxicity rate to the rate published in the ASCENDE-RT trial
time frame: 2 years
description: Grade 3 GU toxicity rate as measured by CTCAE v5.0
measure: Estimate the prevalence of grade 3 or greater GU toxicity
time frame: 2 years
description: Greater than or equal to grade 3 GU toxicity rate as measured by CTCAE v5.0
measure: Estimate GI and sexual toxicity
time frame: 2 years
description: GI and sexual toxicity as measured by CTCAE v5.0 and EPIC-26 survey results
measure: Estimate freedom from biochemical failure (RFS)
time frame: 5 years
description: Prostate-specific antigen (PSA) failure (nadir greater than 2ng/mL)
measure: Estimate rate of undetectable PSA levels
time frame: 5 years
description: PSA less than or equal to 0.2ng/mL
measure: Describe impact of treatment on quality of life
time frame: 2 years
description: EPIC-26 survey results
arm group label: Treatment
arm group type: Other
intervention type: Radiation
intervention name: External Beam Radiation
description: EBRT will be administered every 5 consecutive days for 5 consecutive weeks. This is standard of care practice for this therapy. This may be revised as applicable per treating physician discretion. The dose of radiation will be in accordance with standard clinical practice guidelines for the treatment of prostate cancer.
arm group label: Treatment
other name: EBRT
intervention type: Radiation
intervention name: HDR Brachytherapy
description: HDR brachytherapy will be administered per standard clinical practice (per NCCN guidelines version 1.2020 for prostate cancer), however standard clinical practice may vary between clinicians. Therefore, the dose of 15Gy in 1 fraction and a set of dosimetry guidelines are to be followed for the purposes of this study. A diagnostic MRI will be co-registered with Transrectal Ultrasound (TRUS) to perform the HDR brachytherapy.
arm group label: Treatment
intervention type: Drug
intervention name: Androgen Deprivation Therapy
description: The dosing and administration of ADT will be in accordance with the drug label for the drug(s) used for this purpose. Participants may receive ADT before and/or during the course of this study.
arm group label: Treatment
other name: ADT
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chris Luminais, MD
role: Principal Investigator
affiliation: University of Virginia
last name: Song Wood
phone: 434-243-0008
email: stw2g@uvahealth.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Christopher Luminais, MD
investigator title: Assistant Professor of Radiation Oncology
mesh term: Prostatic Neoplasms
mesh term: Androgens