xml: <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/NCT06037863</url>
    </required_header>
    <id_info>
      <org_study_id>RELIEF</org_study_id>
      <secondary_id>NCI-2023-06451</secondary_id>
      <secondary_id>GMROR2352</secondary_id>
      <secondary_id>23-005799</secondary_id>
      <secondary_id>GMROR2352</secondary_id>
      <nct_id>NCT06037863</nct_id>
    </id_info>
    <brief_title>Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial</brief_title>
    <official_title>RELIEF: Randomized EvaLuation of the Impact of Empty Versus Full Bladder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</source>
    <oversight_info>
      <has_dmc>No</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>
        This clinical trial evaluates the effects of an empty bladder versus (vs.) a full bladder&#xD;
        prior to undergoing a computed tomography (CT) simulation for radiation therapy in patients&#xD;
        with prostate cancer. Radiation therapy is a commonly used treatment for men diagnosed with&#xD;
        prostate cancer. Prior to initiation of a course of radiotherapy, all patients with prostate&#xD;
        cancer undergo a CT simulation that allows for computer-based optimization of radiation dose&#xD;
        delivery to the target tissue (i.e., prostate) and simultaneous dose minimization to&#xD;
        surrounding normal tissues, such as bladder and rectum. Patients are typically given standard&#xD;
        instructions for preparation to present with a reproducible full bladder at the time of CT&#xD;
        simulation and for each subsequent radiation treatment appointment. The goal of bladder&#xD;
        distension is to displace portions of the bladder and bowel away from the highest dose&#xD;
        radiation delivery to the prostate. However, as typical urinary symptoms related to&#xD;
        radiotherapy develop during treatment, some patients are unable to reproduce the bladder&#xD;
        distention achieved at the time of CT simulation. This can result in increased daily&#xD;
        treatment time, sub-optimal reproducibility of patient internal anatomy, and increased stress&#xD;
        for patients and radiation therapy staff. This trial will evaluate the effects of an empty&#xD;
        bladder vs. a full bladder prior to CT simulation and radiation therapy in patients with&#xD;
        prostate cancer and how it effects patient reported outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To determine whether an empty bladder during radiation therapy delivery for prostate&#xD;
        cancer is non-inferior to standard bladder filling for change in patient-reported urinary&#xD;
        symptoms 3 months post-treatment.&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To evaluate whether an empty bladder during radiation therapy delivery for prostate cancer&#xD;
        is non-inferior to standard bladder filling for patient-reported bowel symptoms and&#xD;
        patient-reported severity of urinary symptoms 3 months post-treatment.&#xD;
  &#xD;
        II. To compare physician-assessed genitourinary and gastrointestinal Common Terminology&#xD;
        Criteria for Adverse Events (CTCAE) toxicity related to radiation therapy in patients treated&#xD;
        with a full versus an empty bladder 3 months post-treatment.&#xD;
  &#xD;
        EXPLORATORY OBJECTIVES:&#xD;
  &#xD;
        I. To evaluate the differences in dosimetric parameters, using both absolute and relative&#xD;
        volumetric measures, between the full bladder and empty bladder patients and correlate with&#xD;
        toxicity scores 3 months post-treatment.&#xD;
  &#xD;
        II. To compare patient experience questionnaire answers between arms. III. To compare daily&#xD;
        treatment evaluations by radiation therapists (RTT) between arms.&#xD;
  &#xD;
        IV. To test for moderation of the treatment effect on the primary endpoint by the four&#xD;
        stratification factors.&#xD;
  &#xD;
        V. To evaluate whether an empty bladder during radiation therapy delivery for prostate cancer&#xD;
        is non-inferior to standard bladder filling for patient-reported urinary symptoms at end of&#xD;
        therapy (EOT) and severity, function, and bother 3 months post- treatment.&#xD;
  &#xD;
        OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
  &#xD;
        ARM I: Patients perform standard of care (SOC) bladder filling and then undergo computed&#xD;
        tomography (CT) and radiation therapy in 5-39 fractions at the discretion of the treating&#xD;
        clinician on study.&#xD;
  &#xD;
        ARM II: Patients perform bladder emptying and then undergo CT and radiation therapy in 5-39&#xD;
        fractions at the discretion of the treating clinician on study.&#xD;
  &#xD;
        After completion of study intervention, patients are followed up at 3 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 19, 2023</start_date>
    <completion_date type="Anticipated">September 19, 2028</completion_date>
    <primary_completion_date type="Anticipated">September 19, 2028</primary_completion_date>
    <phase>Phase 2</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>Patient-reported urinary symptoms</measure>
      <time_frame>Baseline, 3 months, 1 and 2 years post radiation therapy (RT)</time_frame>
      <description>Assessed by the change score of urinary irritative/obstructive scale score from the Expanded Prostate Index Composite (EPIC) or EPIC-26 short form questionnaire and compared between patients treated with an empty bladder and standard bladder filling. A t-test will be used to test for non-inferiority of bladder emptying compared to standard bladder filling at the 5% alpha level.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of physician reported gastrointestinal (GI) and genitourinary (GU) adverse events</measure>
      <time_frame>At 3 months post-RT</time_frame>
      <description>Defined as a composite of the hematuria, urinary incontinence, urinary retention, urinary tract pain, urinary frequency, and urinary urgency items from the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0) for the genitourinary toxicities and by a composite of the rectal hemorrhage, diarrhea, and proctitis items from the CTCAE v 5.0 for the gastrointestinal toxicities. The proportion of patients with a grade 2 or higher GU and GI toxicity at 3 months post-RT will be estimated by the number of patients experiencing a grade 2 or higher GU and GI event divided by the total number of evaluable patients, respectively. Comparisons between treatment arms will be made using a Chi-square test with an alpha level of 5%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported bowel quality of life</measure>
      <time_frame>At 3 months post-RT</time_frame>
      <description>Assessed by the bowel scale score from EPIC-26 and compared between patients treated with an empty bladder and standard bladder filling. A t-test will be used to test for non-inferiority of bladder emptying compared to standard bladder filling at the 5% alpha level with a non-inferiority margin of 7 points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported severity of urinary tract symptoms</measure>
      <time_frame>At 3 months post-RT</time_frame>
      <description>Assessed by International Prostate Symptom Score (IPSS) and t-test will be used to test for non-inferiority of bladder emptying compared to standard bladder filling at the 5% alpha level with a non-inferiority margin of 4 points.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">154</enrollment>
    <condition>Prostate Carcinoma</condition>
    <arm_group>
      <arm_group_label>Arm I (bladder filling, CT, radiation)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients perform SOC bladder filling and then undergo CT and radiation therapy in 5-39 fractions at the discretion of the treating clinician on study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm II (bladder emptying, CT, radiation)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients perform bladder emptying and then undergo CT and radiation therapy in 5-39 fractions at the discretion of the treating clinician on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Best Practice</intervention_name>
      <description>Undergo bladder filling prior to CT</description>
      <arm_group_label>Arm I (bladder filling, CT, radiation)</arm_group_label>
      <other_name>standard of care</other_name>
      <other_name>standard therapy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Computed Tomography</intervention_name>
      <description>Undergo CT</description>
      <arm_group_label>Arm I (bladder filling, CT, radiation)</arm_group_label>
      <arm_group_label>Arm II (bladder emptying, CT, radiation)</arm_group_label>
      <other_name>CAT</other_name>
      <other_name>CAT Scan</other_name>
      <other_name>Computed Axial Tomography</other_name>
      <other_name>Computerized Axial Tomography</other_name>
      <other_name>Computerized axial tomography (procedure)</other_name>
      <other_name>Computerized Tomography</other_name>
      <other_name>CT</other_name>
      <other_name>CT Scan</other_name>
      <other_name>tomography</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Electronic Health Record Review</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm I (bladder filling, CT, radiation)</arm_group_label>
      <arm_group_label>Arm II (bladder emptying, CT, radiation)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Imaging Technique</intervention_name>
      <description>Undergo bladder emptying prior to CT</description>
      <arm_group_label>Arm II (bladder emptying, CT, radiation)</arm_group_label>
      <other_name>Diagnostic Imaging Technique</other_name>
      <other_name>Image Type</other_name>
      <other_name>Imaging</other_name>
      <other_name>Imaging (procedure)</other_name>
      <other_name>imaging procedure</other_name>
      <other_name>Imaging Procedures</other_name>
      <other_name>imaging type</other_name>
      <other_name>IMAGING_METHOD</other_name>
      <other_name>imaging_type</other_name>
      <other_name>Medical Imaging</other_name>
      <other_name>Type of imaging</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire Administration</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm I (bladder filling, CT, radiation)</arm_group_label>
      <arm_group_label>Arm II (bladder emptying, CT, radiation)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Radiation Therapy</intervention_name>
      <description>Undergo radiation therapy</description>
      <arm_group_label>Arm I (bladder filling, CT, radiation)</arm_group_label>
      <arm_group_label>Arm II (bladder emptying, CT, radiation)</arm_group_label>
      <other_name>Cancer Radiotherapy</other_name>
      <other_name>Energy Type</other_name>
      <other_name>ENERGY_TYPE</other_name>
      <other_name>Irradiate</other_name>
      <other_name>Irradiated</other_name>
      <other_name>Irradiation</other_name>
      <other_name>Radiation</other_name>
      <other_name>Radiation Therapy, NOS</other_name>
      <other_name>Radiotherapeutics</other_name>
      <other_name>Radiotherapy</other_name>
      <other_name>RT</other_name>
      <other_name>Therapy, Radiation</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;= 18 years&#xD;
  &#xD;
            -  Histological confirmation of prostate cancer&#xD;
  &#xD;
            -  Planned definitive dose radiotherapy to the prostate&#xD;
  &#xD;
                 -  Note: Patients are eligible for enrollment if they are already enrolled or&#xD;
                    planned for enrollment on another interventional research protocol provided that&#xD;
                    other study protocol treatment does not require procedures or treatments that&#xD;
                    would be in conflict with the eligibility or treatment protocols for this study&#xD;
                    nor, in the judgement of the enrolling physician, affect primary study objectives&#xD;
                    of this study&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2&#xD;
  &#xD;
            -  Ability to complete questionnaire(s) by themselves or with assistance&#xD;
  &#xD;
            -  Provide written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Planned delivery of radiotherapy to pelvic lymph nodes&#xD;
  &#xD;
            -  Planned brachytherapy treatment of the prostate&#xD;
  &#xD;
            -  Significant urinary incontinence that precludes standard bladder filling&#xD;
  &#xD;
            -  Evidence of direct bladder extension or bladder wall metastases from prostate cancer&#xD;
  &#xD;
            -  Used indwelling or intermittent urinary catheterization at baseline&#xD;
  &#xD;
            -  Prior pelvic radiotherapy such that any portion of the prostate received &gt; 5 Gy&#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>Bradley J. Stish, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mayo Clinic in Arizona</name>
        <address>
          <city>Scottsdale</city>
          <state>Arizona</state>
          <zip>85259</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Jean Claude M. Rwigema, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic in Florida</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32224-9980</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Albert N. Attia, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic Health System in Albert Lea</name>
        <address>
          <city>Albert Lea</city>
          <state>Minnesota</state>
          <zip>56007</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Timothy F. Kozelsky, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic Health Systems-Mankato</name>
        <address>
          <city>Mankato</city>
          <state>Minnesota</state>
          <zip>56001</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Ron S. Smith, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic in Rochester</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Bradley J. Stish, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic Health System-Eau Claire Clinic</name>
        <address>
          <city>Eau Claire</city>
          <state>Wisconsin</state>
          <zip>54701</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Zachary C. Wilson, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic Health System-Franciscan Healthcare</name>
        <address>
          <city>La Crosse</city>
          <state>Wisconsin</state>
          <zip>54601</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Abigail L. Stockham, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</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>
  
  
text: 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/NCT06037863
  org study id: RELIEF
  secondary id: NCI-2023-06451
  secondary id: GMROR2352
  secondary id: 23-005799
  secondary id: GMROR2352
  nct id: NCT06037863
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial evaluates the effects of an empty bladder versus (vs.) a full bladder
        prior to undergoing a computed tomography (CT) simulation for radiation therapy in patients
        with prostate cancer. Radiation therapy is a commonly used treatment for men diagnosed with
        prostate cancer. Prior to initiation of a course of radiotherapy, all patients with prostate
        cancer undergo a CT simulation that allows for computer-based optimization of radiation dose
        delivery to the target tissue (i.e., prostate) and simultaneous dose minimization to
        surrounding normal tissues, such as bladder and rectum. Patients are typically given standard
        instructions for preparation to present with a reproducible full bladder at the time of CT
        simulation and for each subsequent radiation treatment appointment. The goal of bladder
        distension is to displace portions of the bladder and bowel away from the highest dose
        radiation delivery to the prostate. However, as typical urinary symptoms related to
        radiotherapy develop during treatment, some patients are unable to reproduce the bladder
        distention achieved at the time of CT simulation. This can result in increased daily
        treatment time, sub-optimal reproducibility of patient internal anatomy, and increased stress
        for patients and radiation therapy staff. This trial will evaluate the effects of an empty
        bladder vs. a full bladder prior to CT simulation and radiation therapy in patients with
        prostate cancer and how it effects patient reported outcomes.
  PRIMARY OBJECTIVE:
  
        I. To determine whether an empty bladder during radiation therapy delivery for prostate
        cancer is non-inferior to standard bladder filling for change in patient-reported urinary
        symptoms 3 months post-treatment.
  
        SECONDARY OBJECTIVES:
  
        I. To evaluate whether an empty bladder during radiation therapy delivery for prostate cancer
        is non-inferior to standard bladder filling for patient-reported bowel symptoms and
        patient-reported severity of urinary symptoms 3 months post-treatment.
  
        II. To compare physician-assessed genitourinary and gastrointestinal Common Terminology
        Criteria for Adverse Events (CTCAE) toxicity related to radiation therapy in patients treated
        with a full versus an empty bladder 3 months post-treatment.
  
        EXPLORATORY OBJECTIVES:
  
        I. To evaluate the differences in dosimetric parameters, using both absolute and relative
        volumetric measures, between the full bladder and empty bladder patients and correlate with
        toxicity scores 3 months post-treatment.
  
        II. To compare patient experience questionnaire answers between arms. III. To compare daily
        treatment evaluations by radiation therapists (RTT) between arms.
  
        IV. To test for moderation of the treatment effect on the primary endpoint by the four
        stratification factors.
  
        V. To evaluate whether an empty bladder during radiation therapy delivery for prostate cancer
        is non-inferior to standard bladder filling for patient-reported urinary symptoms at end of
        therapy (EOT) and severity, function, and bother 3 months post- treatment.
  
        OUTLINE: Patients are randomized to 1 of 2 arms.
  
        ARM I: Patients perform standard of care (SOC) bladder filling and then undergo computed
        tomography (CT) and radiation therapy in 5-39 fractions at the discretion of the treating
        clinician on study.
  
        ARM II: Patients perform bladder emptying and then undergo CT and radiation therapy in 5-39
        fractions at the discretion of the treating clinician on study.
  
        After completion of study intervention, patients are followed up at 3 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Patient-reported urinary symptoms
  time frame: Baseline, 3 months, 1 and 2 years post radiation therapy (RT)
  description: Assessed by the change score of urinary irritative/obstructive scale score from the Expanded Prostate Index Composite (EPIC) or EPIC-26 short form questionnaire and compared between patients treated with an empty bladder and standard bladder filling. A t-test will be used to test for non-inferiority of bladder emptying compared to standard bladder filling at the 5% alpha level.
  measure: Incidence of physician reported gastrointestinal (GI) and genitourinary (GU) adverse events
  time frame: At 3 months post-RT
  description: Defined as a composite of the hematuria, urinary incontinence, urinary retention, urinary tract pain, urinary frequency, and urinary urgency items from the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0) for the genitourinary toxicities and by a composite of the rectal hemorrhage, diarrhea, and proctitis items from the CTCAE v 5.0 for the gastrointestinal toxicities. The proportion of patients with a grade 2 or higher GU and GI toxicity at 3 months post-RT will be estimated by the number of patients experiencing a grade 2 or higher GU and GI event divided by the total number of evaluable patients, respectively. Comparisons between treatment arms will be made using a Chi-square test with an alpha level of 5%.
  measure: Patient-reported bowel quality of life
  time frame: At 3 months post-RT
  description: Assessed by the bowel scale score from EPIC-26 and compared between patients treated with an empty bladder and standard bladder filling. A t-test will be used to test for non-inferiority of bladder emptying compared to standard bladder filling at the 5% alpha level with a non-inferiority margin of 7 points.
  measure: Patient-reported severity of urinary tract symptoms
  time frame: At 3 months post-RT
  description: Assessed by International Prostate Symptom Score (IPSS) and t-test will be used to test for non-inferiority of bladder emptying compared to standard bladder filling at the 5% alpha level with a non-inferiority margin of 4 points.
  arm group label: Arm I (bladder filling, CT, radiation)
  arm group type: Active Comparator
  description: Patients perform SOC bladder filling and then undergo CT and radiation therapy in 5-39 fractions at the discretion of the treating clinician on study.
  arm group label: Arm II (bladder emptying, CT, radiation)
  arm group type: Experimental
  description: Patients perform bladder emptying and then undergo CT and radiation therapy in 5-39 fractions at the discretion of the treating clinician on study.
  intervention type: Other
  intervention name: Best Practice
  description: Undergo bladder filling prior to CT
  arm group label: Arm I (bladder filling, CT, radiation)
  other name: standard of care
  other name: standard therapy
  intervention type: Procedure
  intervention name: Computed Tomography
  description: Undergo CT
  arm group label: Arm I (bladder filling, CT, radiation)
  arm group label: Arm II (bladder emptying, CT, radiation)
  other name: CAT
  other name: CAT Scan
  other name: Computed Axial Tomography
  other name: Computerized Axial Tomography
  other name: Computerized axial tomography (procedure)
  other name: Computerized Tomography
  other name: CT
  other name: CT Scan
  other name: tomography
  intervention type: Other
  intervention name: Electronic Health Record Review
  description: Ancillary studies
  arm group label: Arm I (bladder filling, CT, radiation)
  arm group label: Arm II (bladder emptying, CT, radiation)
  intervention type: Procedure
  intervention name: Imaging Technique
  description: Undergo bladder emptying prior to CT
  arm group label: Arm II (bladder emptying, CT, radiation)
  other name: Diagnostic Imaging Technique
  other name: Image Type
  other name: Imaging
  other name: Imaging (procedure)
  other name: imaging procedure
  other name: Imaging Procedures
  other name: imaging type
  other name: IMAGING_METHOD
  other name: imaging_type
  other name: Medical Imaging
  other name: Type of imaging
  intervention type: Other
  intervention name: Questionnaire Administration
  description: Ancillary studies
  arm group label: Arm I (bladder filling, CT, radiation)
  arm group label: Arm II (bladder emptying, CT, radiation)
  intervention type: Radiation
  intervention name: Radiation Therapy
  description: Undergo radiation therapy
  arm group label: Arm I (bladder filling, CT, radiation)
  arm group label: Arm II (bladder emptying, CT, radiation)
  other name: Cancer Radiotherapy
  other name: Energy Type
  other name: ENERGY_TYPE
  other name: Irradiate
  other name: Irradiated
  other name: Irradiation
  other name: Radiation
  other name: Radiation Therapy, NOS
  other name: Radiotherapeutics
  other name: Radiotherapy
  other name: RT
  other name: Therapy, Radiation
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bradley J. Stish, M.D.
  role: Principal Investigator
  affiliation: Mayo Clinic
  last name: Clinical Trials Referral Office
  phone: 855-776-0015
  email: mayocliniccancerstudies@mayo.edu
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  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms