<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/NCT03748719</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-19670</org_study_id>
    <nct_id>NCT03748719</nct_id>
  </id_info>
  <brief_title>Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer</brief_title>
  <official_title>A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lee Moffitt Cancer Center and Research Institute</source>
  <oversight_info>
    <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 study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy&#xD;
      (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses&#xD;
      of radiation are delivered to small, well-defined tumors. It has been used effectively in&#xD;
      other cancers like lung and liver. The radiation will be given for only 5 days.&#xD;
&#xD;
      The purpose of this study is to compare the effects, good and/or bad, of different doses of&#xD;
      SBRT given before prostatectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No accrual interest&#xD;
  </why_stopped>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Actual">December 4, 2019</completion_date>
  <primary_completion_date type="Actual">October 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of PSA (Prostate Specific Antigen)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Measure of PSA through treatment. PSA is expected to be undetectable (&lt;0.2 mg/ml) after prostatectomy and radiation therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of symptomatic adverse anastomotic events</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Number of symptomatic anastomotic events related to pre-operative SBRT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Catheterization Time</measure>
    <time_frame>Up to 4 weeks post surgery</time_frame>
    <description>Average time of catheterization following prostatectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Hospital Stay</measure>
    <time_frame>Up to 2 week post surgery</time_frame>
    <description>Average time of hospitalization after prostatectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life assessment</measure>
    <time_frame>Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery</time_frame>
    <description>Quality of Life will be assessed using 2 questionnaires: International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM). The IPSS is an eight question questionnaire of symptoms ranging from 0 &quot;not at all&quot; to 5 &quot;always&quot;. The SHIM is a five question questionnaire ranging from 1 &quot;almost never or never&quot; to 5 &quot;almost always or always&quot; to determine erectile dysfunction.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Stereotactic Body Radiation Therapy, followed by Prostatectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stereotactic Body Radiation Therapy (SBRT)</intervention_name>
    <description>SBRT treatment</description>
    <arm_group_label>Stereotactic Body Radiation Therapy, followed by Prostatectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Histologically proven prostate adenocarcinoma.&#xD;
&#xD;
          -  Clinical stage ≤T3a based on digital rectal exam (DRE) and ≤T3a based on MRI (within 3&#xD;
             months); N0-Nx; M0-Mx, or Gleason score 4 + 4. No more than 1 lymph node &gt;1 cm.&#xD;
&#xD;
          -  PSA ≤ 50 ng/ml, obtained within 3 months&#xD;
&#xD;
          -  Prostate volume: ≤60 cc.&#xD;
&#xD;
          -  IPSS score ≤15.&#xD;
&#xD;
          -  No previous radiotherapy to the prostate or lower pelvis.&#xD;
&#xD;
          -  Lymph node risk of &lt;35% using https://www.mskcc.org/nomograms/prostate/pre_op.&#xD;
&#xD;
          -  No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral&#xD;
             resection or laser ablation are permitted).&#xD;
&#xD;
          -  No implanted hardware or other material that would prohibit appropriate treatment&#xD;
             planning or treatment delivery, in the investigator's opinion.&#xD;
&#xD;
          -  No history of an invasive malignancy (other than this prostate cancer, or&#xD;
             non-metastatic basal or squamous skin cancers) in the last 3 years.&#xD;
&#xD;
          -  No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation&#xD;
             therapy.&#xD;
&#xD;
          -  Participant must be able to have gold fiducial markers placed in the prostate. Note:&#xD;
             patients can be enrolled after fiducial markers have been placed, as long as the&#xD;
             procedure was done in accordance with the protocol (Section 4.2.2).&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
          -  Willing to fill out quality of life questionnaires.&#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>Peter Johnstone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Lee Moffitt Cancer Center and Research Institute</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://moffitt.org/clinical-trials-research/clinical-trials/</url>
    <description>Moffitt Cancer Center Clinical Trials Website</description>
  </link>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>High Risk Prostate Cancer</keyword>
  <keyword>prostate</keyword>
  <keyword>radiation therapy</keyword>
  <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/NCT03748719
org study id: MCC-19670
nct id: NCT03748719
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy
      (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses
      of radiation are delivered to small, well-defined tumors. It has been used effectively in
      other cancers like lung and liver. The radiation will be given for only 5 days.

      The purpose of this study is to compare the effects, good and/or bad, of different doses of
      SBRT given before prostatectomy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Measure of PSA (Prostate Specific Antigen)
time frame: Up to 12 months
description: Measure of PSA through treatment. PSA is expected to be undetectable (<0.2 mg/ml) after prostatectomy and radiation therapy.
measure: Number of symptomatic adverse anastomotic events
time frame: Up to 12 months
description: Number of symptomatic anastomotic events related to pre-operative SBRT.
measure: Mean Catheterization Time
time frame: Up to 4 weeks post surgery
description: Average time of catheterization following prostatectomy
measure: Mean Hospital Stay
time frame: Up to 2 week post surgery
description: Average time of hospitalization after prostatectomy
measure: Quality of Life assessment
time frame: Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery
description: Quality of Life will be assessed using 2 questionnaires: International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM). The IPSS is an eight question questionnaire of symptoms ranging from 0 "not at all" to 5 "always". The SHIM is a five question questionnaire ranging from 1 "almost never or never" to 5 "almost always or always" to determine erectile dysfunction.
arm group label: Stereotactic Body Radiation Therapy, followed by Prostatectomy
arm group type: Experimental
description: Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.
intervention type: Device
intervention name: Stereotactic Body Radiation Therapy (SBRT)
description: SBRT treatment
arm group label: Stereotactic Body Radiation Therapy, followed by Prostatectomy
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Johnstone, MD
role: Principal Investigator
affiliation: H. Lee Moffitt Cancer Center and Research Institute
country: United States
url: http://moffitt.org/clinical-trials-research/clinical-trials/
description: Moffitt Cancer Center Clinical Trials Website
responsible party type: Sponsor
mesh term: Prostatic Neoplasms