<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/NCT03233672</url>
  </required_header>
  <id_info>
    <org_study_id>Iside-PP-2</org_study_id>
    <nct_id>NCT03233672</nct_id>
  </id_info>
  <brief_title>Hypo-fractionated Postoperative IMRT in Prostate Cancer</brief_title>
  <official_title>Hypofractionated Post-operative IMRT in Prostate Carcinoma: a Phase I/II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Howard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (RP) for&#xD;
      prostate cancer (PCa) using IMRT-SIB. 124 patients with PCa at high risk of relapse after RP&#xD;
      or diagnosis of biochemical relapse were included. Patients received 62.5 Gy to the prostate&#xD;
      bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was&#xD;
      prescribed based on NCCN risk categories. Median follow-up was 30 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To report the outcome of hypo-fractionated radiation therapy after radical prostatectomy (RP)&#xD;
      for prostate cancer (PCa) using intensity-modulated radiation treatment with simultaneous&#xD;
      integrated boost (IMRT-SIB).&#xD;
&#xD;
      One hundred and twenty-four patients with PCa at high risk of relapse after RP or diagnosis&#xD;
      of biochemical relapse were included in this phase II study (adjuvant: 106 patients, salvage:&#xD;
      18 patients). All patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis&#xD;
      nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk&#xD;
      categories. Acute and late toxicities were recorded and evaluated according to RTOG&#xD;
      (Radiation Therapy Oncology Group) criteria and RTOG-EORTC (European Organization for&#xD;
      Research and Treatment of Cancer) scale, respectively.&#xD;
&#xD;
      Median follow-up was 30 months (13-92).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2007</start_date>
  <completion_date type="Actual">September 18, 2014</completion_date>
  <primary_completion_date type="Actual">September 18, 2010</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>incidence of early treatment-emergent adverse events</measure>
    <time_frame>&lt; 90 days</time_frame>
    <description>adverse events after radiotherapy. Acute side effets were scored according to the Radiation Therapy Oncology Group (RTOG) scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical relapse free survival</measure>
    <time_frame>5 years</time_frame>
    <description>Survival free from increase of PSA livel exceeding 0.2 ng/mL for those with post surgical PSA livel of 0.2 ng/mL or lower, and as two consecutive PSA increases for patients with a postsurgical PSA livel of &gt; 0.2 ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of late treatment-emergent adverse events were assessed with Radiation</measure>
    <time_frame>5 years</time_frame>
    <description>Late complications were assessed with delete Radiation Morbidity Scoring Scheme of the RTOG/European Organization for Research and Treatment of Cancer (EORTC)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>First evidence of any pelvic recurrence</measure>
    <time_frame>5 years</time_frame>
    <description>First evidence of any pelvic recurrence</description>
  </other_outcome>
  <other_outcome>
    <measure>Metastasis-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>The first evidence of any extrapelvic recurrence of disease</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Hypo-fractionated postoperative IMRT-SIB</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients underwent combined, intensified and modulated radiotherapy for five days a week with the following doses: 62.5 Gy to the prostate bed and 45 Gy to pelvis nodes in 25 fractions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Hypo-fractionated postoperative IMRT-SIB</intervention_name>
    <description>intensity-modulated radiation treatment with simultaneous integrated boost</description>
    <arm_group_label>Hypo-fractionated postoperative IMRT-SIB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years&#xD;
&#xD;
          -  prior radical prostatectomy with or without lymphadenectomy&#xD;
&#xD;
          -  high-risk patients (positive surgical margins, and/or extracapsular extension, and/or&#xD;
             seminal vescicle invasion, and/or probability of nodal metastasis &gt; 7% calculated by&#xD;
             the Roach formula after pelvic lymph node dissection with ≤ 13 nodes removed, and/or&#xD;
             presence of any positive pelvic nodes) or patients with biochemical relapse (initial&#xD;
             post-surgery serum PSA equal or above 0.2 ng/mL with a second confirmatory PSA of the&#xD;
             same value)&#xD;
&#xD;
          -  ECOG performance status 0-1&#xD;
&#xD;
          -  adequate bone marrow function (hemoglobin concentration &gt; 8 g/dl, white blood cell&#xD;
             count &gt; 3,000/ mm³, platelet count &gt; 75,000/ mm³)&#xD;
&#xD;
          -  pre-treatment computed tomography (CT) scan or magnetic resonance imaging (MRI) of the&#xD;
             abdomen and pelvis&#xD;
&#xD;
          -  bone scan&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior pelvic radiotherapy&#xD;
&#xD;
          -  distant metastases&#xD;
&#xD;
          -  macroscopic residual tumor&#xD;
&#xD;
          -  pelvic or para-aortic nodes at re-evaluation imaging after surgery&#xD;
&#xD;
          -  secondary malignancies&#xD;
&#xD;
          -  genetic syndromes of hyper-radio-sensitivity&#xD;
&#xD;
          -  chronic inflammatory bowel disease&#xD;
&#xD;
          -  previously treated with androgen deprivation therapy&#xD;
&#xD;
          -  previously treated with chemotherapy for prostate cancer&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessio G Morganti, MD</last_name>
    <role>Study Director</role>
    <affiliation>Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy</affiliation>
  </overall_official>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>Alessio Giuseppe Morganti</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>adjuvant</keyword>
  <keyword>hypofractionation</keyword>
  <keyword>IMRT</keyword>
  <keyword>phase I-II</keyword>
  <keyword>prostate neoplasms</keyword>
  <keyword>radiotherapy</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>
  <!-- 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/NCT03233672
org study id: Iside-PP-2
nct id: NCT03233672
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (RP) for
      prostate cancer (PCa) using IMRT-SIB. 124 patients with PCa at high risk of relapse after RP
      or diagnosis of biochemical relapse were included. Patients received 62.5 Gy to the prostate
      bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was
      prescribed based on NCCN risk categories. Median follow-up was 30 months.
To report the outcome of hypo-fractionated radiation therapy after radical prostatectomy (RP)
      for prostate cancer (PCa) using intensity-modulated radiation treatment with simultaneous
      integrated boost (IMRT-SIB).

      One hundred and twenty-four patients with PCa at high risk of relapse after RP or diagnosis
      of biochemical relapse were included in this phase II study (adjuvant: 106 patients, salvage:
      18 patients). All patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis
      nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk
      categories. Acute and late toxicities were recorded and evaluated according to RTOG
      (Radiation Therapy Oncology Group) criteria and RTOG-EORTC (European Organization for
      Research and Treatment of Cancer) scale, respectively.

      Median follow-up was 30 months (13-92).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: incidence of early treatment-emergent adverse events
time frame: < 90 days
description: adverse events after radiotherapy. Acute side effets were scored according to the Radiation Therapy Oncology Group (RTOG) scale.
measure: Biochemical relapse free survival
time frame: 5 years
description: Survival free from increase of PSA livel exceeding 0.2 ng/mL for those with post surgical PSA livel of 0.2 ng/mL or lower, and as two consecutive PSA increases for patients with a postsurgical PSA livel of > 0.2 ng/mL
measure: incidence of late treatment-emergent adverse events were assessed with Radiation
time frame: 5 years
description: Late complications were assessed with delete Radiation Morbidity Scoring Scheme of the RTOG/European Organization for Research and Treatment of Cancer (EORTC)
measure: First evidence of any pelvic recurrence
time frame: 5 years
description: First evidence of any pelvic recurrence
measure: Metastasis-free survival
time frame: 5 years
description: The first evidence of any extrapelvic recurrence of disease
arm group label: Hypo-fractionated postoperative IMRT-SIB
arm group type: Other
description: All patients underwent combined, intensified and modulated radiotherapy for five days a week with the following doses: 62.5 Gy to the prostate bed and 45 Gy to pelvis nodes in 25 fractions.
intervention type: Radiation
intervention name: Hypo-fractionated postoperative IMRT-SIB
description: intensity-modulated radiation treatment with simultaneous integrated boost
arm group label: Hypo-fractionated postoperative IMRT-SIB
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Alessio G Morganti, MD
role: Study Director
affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: Alessio Giuseppe Morganti
investigator title: Professor
mesh term: Prostatic Neoplasms
sharing ipd: No