<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/NCT03034187</url>
  </required_header>
  <id_info>
    <org_study_id>H1998-12/SFP-Prostate</org_study_id>
    <nct_id>NCT03034187</nct_id>
  </id_info>
  <brief_title>Radiation-induced Toxicity in Prostate Cancer/ Standard-Follow-Up Program Prostate</brief_title>
  <acronym>SFP-PROSTATE</acronym>
  <official_title>Radiation Induced Toxicity in Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal is to gain insight in the development and course of the toxicity after a curative&#xD;
      treatment of prostate cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All with curative intent treated prostate cancer patients will be enrolled in the SFP&#xD;
      (Standard Follow-up Programme). It also includes the post -operative adjuvant treatments and&#xD;
      the patients with positive lymph nodes.&#xD;
&#xD;
      Patients will complete weekly questionnaires to score the patient -rated toxicity. Biweekly&#xD;
      patients are seen by the treating radiation oncologist and / or AIOS in which the physician&#xD;
      -rated toxicity is scored. In the follow-up will always patient -rated toxicity and physician&#xD;
      -rated toxicity can be determined.&#xD;
&#xD;
      Use of an SFP should yield a profit for the practitioner , such as the automatic generation&#xD;
      of letters. This should apply to all SFPs .&#xD;
&#xD;
      Quality of life and toxicity in patients will be completed on the touch-screen computers at&#xD;
      FU visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>April 1999</start_date>
  <completion_date type="Anticipated">January 2028</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>1. Change in Acute toxicity</measure>
    <time_frame>Toxicity:First visit/Wekely during RT, Acute Toxicity: 2-wekely and at the end of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT</time_frame>
    <description>Common Terminology Criteria for Adverse Events, version 4.0&#xD;
CTCAE 4.0 Constipation&#xD;
CTCAE 4.0 Diarrhea&#xD;
CTCAE 4.0 Fecal Incontinence&#xD;
CTCAE 4.0 Flatulance&#xD;
CTCAE 4.0 Proctitis&#xD;
CTCAE 4.0 Rectal Hemorrhage&#xD;
CTCAE 4.0 Rectal Mucositis&#xD;
CTCAE 4.0 Rectal Ulcer&#xD;
CTCAE 4.0 Bladder spasm&#xD;
CTCAE 4.0 Cystitis Noninfective&#xD;
CTCAE 4.0 Hematuria&#xD;
CTCAE 4.0 Urinary Frequency&#xD;
CTCAE 4.0 Urinary Incontinence&#xD;
CTCAE 4.0 Urinary retention&#xD;
CTCAE 4.0 Urinary tract Obstruction&#xD;
CTCAE 4.0 Urinary tract pain&#xD;
CTCAE 4.0 Urinary Urgency&#xD;
CTCAE 4.0 Erectile dysfunction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2. Change in patient -rated Quality-of-Life</measure>
    <time_frame>First visit/End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT</time_frame>
    <description>Questionnarys QLQ-PR25, QLQ-C30, International Index of Erectile Function</description>
  </secondary_outcome>
  <other_outcome>
    <measure>3. Change in physiological parameters</measure>
    <time_frame>First visit/2 months after RT/1, 2, 3, 4, 5 years after RT</time_frame>
    <description>PSA and Testosteron</description>
  </other_outcome>
  <other_outcome>
    <measure>4. Change in Acute/ Late toxicity(physician rated)</measure>
    <time_frame>First Visit/ 2 wekely/ End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT</time_frame>
    <description>Common Terminology Criteria for Adverse Events, version 4.0&#xD;
CTCAE 4.0 Constipation&#xD;
CTCAE 4.0 Diarrhea&#xD;
CTCAE 4.0 Fecal Incontinence&#xD;
CTCAE 4.0 Flatulance&#xD;
CTCAE 4.0 Proctitis&#xD;
CTCAE 4.0 Rectal Hemorrhage&#xD;
CTCAE 4.0 Rectal Mucositis&#xD;
CTCAE 4.0 Rectal Ulcer&#xD;
CTCAE 4.0 Bladder spasm&#xD;
CTCAE 4.0 Cystitis Noninfective&#xD;
CTCAE 4.0 Hematuria&#xD;
CTCAE 4.0 Urinary Frequency&#xD;
CTCAE 4.0 Urinary Incontinence&#xD;
CTCAE 4.0 Urinary retention&#xD;
CTCAE 4.0 Urinary tract Obstruction&#xD;
CTCAE 4.0 Urinary tract pain&#xD;
CTCAE 4.0 Urinary Urgency&#xD;
CTCAE 4.0 Erectile dysfunction</description>
  </other_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Prostate Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All with curative intent treated prostate cancer patients who will be treated with RT will&#xD;
        be enrolled in the SFP.&#xD;
&#xD;
        It also includes the post-surgical adjuvant treatment and patients with positive lymph&#xD;
        nodes to research the development and toxicity after RT&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All curative treated patients with prostatecancer( with positive lymph nodes)&#xD;
&#xD;
          -  All patients who will be treated with RT( including post-operative, adjuvant&#xD;
             treatments)&#xD;
&#xD;
          -  Are willing to fill in toxicity and QOL-questionnarys (QLQ-PR25 en de QLQ-C30)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who are not willing to fill in toxicity and QOL-questionnarys Patients who will&#xD;
        not get RT Non-curative or palliative treated patients (with bone mestasis) Non-prostate&#xD;
        cancer-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_contact>
    <last_name>S. Aluwini, MD PhD</last_name>
    <phone>+31503612346</phone>
    <email>s.al-uwini@umcg.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>L.W. Kors, Msc</last_name>
    <phone>+31503617244</phone>
    <email>l.w.kors@umcg.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9700RB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A.C.M Van Den Bergh, MD PhD</last_name>
      <phone>+31503611194</phone>
      <email>a.c.m.van.den.bergh@umcg.nl</email>
    </contact>
    <investigator>
      <last_name>A.C.M Van Den Bergh, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>November 5, 2020</last_update_submitted>
  <last_update_submitted_qc>November 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Shafak Al-Uwini</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Acute toxicity</keyword>
  <keyword>Late toxicity</keyword>
  <keyword>Quality of Life since 2011(set-up SFP-prostate)</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>Yes</sharing_ipd>
    <ipd_description>Sharing data between physicians at the Department of Radiotherapy</ipd_description>
  </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/NCT03034187
org study id: H1998-12/SFP-Prostate
nct id: NCT03034187
lead sponsor: 
has dmc: No
The goal is to gain insight in the development and course of the toxicity after a curative
      treatment of prostate cancer
All with curative intent treated prostate cancer patients will be enrolled in the SFP
      (Standard Follow-up Programme). It also includes the post -operative adjuvant treatments and
      the patients with positive lymph nodes.

      Patients will complete weekly questionnaires to score the patient -rated toxicity. Biweekly
      patients are seen by the treating radiation oncologist and / or AIOS in which the physician
      -rated toxicity is scored. In the follow-up will always patient -rated toxicity and physician
      -rated toxicity can be determined.

      Use of an SFP should yield a profit for the practitioner , such as the automatic generation
      of letters. This should apply to all SFPs .

      Quality of life and toxicity in patients will be completed on the touch-screen computers at
      FU visits.
observational model: Cohort
time perspective: Prospective
measure: 1. Change in Acute toxicity
time frame: Toxicity:First visit/Wekely during RT, Acute Toxicity: 2-wekely and at the end of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
description: Common Terminology Criteria for Adverse Events, version 4.0
CTCAE 4.0 Constipation
CTCAE 4.0 Diarrhea
CTCAE 4.0 Fecal Incontinence
CTCAE 4.0 Flatulance
CTCAE 4.0 Proctitis
CTCAE 4.0 Rectal Hemorrhage
CTCAE 4.0 Rectal Mucositis
CTCAE 4.0 Rectal Ulcer
CTCAE 4.0 Bladder spasm
CTCAE 4.0 Cystitis Noninfective
CTCAE 4.0 Hematuria
CTCAE 4.0 Urinary Frequency
CTCAE 4.0 Urinary Incontinence
CTCAE 4.0 Urinary retention
CTCAE 4.0 Urinary tract Obstruction
CTCAE 4.0 Urinary tract pain
CTCAE 4.0 Urinary Urgency
CTCAE 4.0 Erectile dysfunction
measure: 2. Change in patient -rated Quality-of-Life
time frame: First visit/End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
description: Questionnarys QLQ-PR25, QLQ-C30, International Index of Erectile Function
measure: 3. Change in physiological parameters
time frame: First visit/2 months after RT/1, 2, 3, 4, 5 years after RT
description: PSA and Testosteron
measure: 4. Change in Acute/ Late toxicity(physician rated)
time frame: First Visit/ 2 wekely/ End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
description: Common Terminology Criteria for Adverse Events, version 4.0
CTCAE 4.0 Constipation
CTCAE 4.0 Diarrhea
CTCAE 4.0 Fecal Incontinence
CTCAE 4.0 Flatulance
CTCAE 4.0 Proctitis
CTCAE 4.0 Rectal Hemorrhage
CTCAE 4.0 Rectal Mucositis
CTCAE 4.0 Rectal Ulcer
CTCAE 4.0 Bladder spasm
CTCAE 4.0 Cystitis Noninfective
CTCAE 4.0 Hematuria
CTCAE 4.0 Urinary Frequency
CTCAE 4.0 Urinary Incontinence
CTCAE 4.0 Urinary retention
CTCAE 4.0 Urinary tract Obstruction
CTCAE 4.0 Urinary tract pain
CTCAE 4.0 Urinary Urgency
CTCAE 4.0 Erectile dysfunction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: S. Aluwini, MD PhD
phone: +31503612346
email: s.al-uwini@umcg.nl
last name: L.W. Kors, Msc
phone: +31503617244
email: l.w.kors@umcg.nl
facility: 
status: Recruiting
contact: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Shafak Al-Uwini
investigator title: MD, PhD
mesh term: Prostatic Neoplasms
sharing ipd: Yes
ipd description: Sharing data between physicians at the Department of Radiotherapy