<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/NCT04484038</url>
  </required_header>
  <id_info>
    <org_study_id>HYPORT-ES</org_study_id>
    <nct_id>NCT04484038</nct_id>
  </id_info>
  <brief_title>Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma</brief_title>
  <official_title>Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo de Investigación Clínica en Oncología Radioterapia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grupo de Investigación Clínica en Oncología Radioterapia</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>
      The objective of this study is to evaluate, in patients diagnosed with prostate cancer who&#xD;
      undergo radical prostatectomy and who require postoperative radiotherapy, tolerance in terms&#xD;
      of acute and chronic GU and GI toxicity and efficacy in terms of biochemical control and&#xD;
      survival, as well as of quality of life, from a hypofractional external radiotherapy scheme,&#xD;
      increasing the dose per fraction in a shorter period of time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      What the investigators present in this study is a hypofractionation scheme of 62.5 Gy in 25&#xD;
      daily fractions of 2.5 Gy / day, which was chosen to provide a biological equivalent dose&#xD;
      (BED) of 166.67 Gy, comparable to the 163 Gy administered with a scheme Normally divided up&#xD;
      to 70 Gy in daily fractions of 2 Gy / day Version 2.0, March 27, 2019&#xD;
&#xD;
      (assuming an α / β ratio of 1.5 Gy for prostate cancer). The BED in risk organs (mainly&#xD;
      rectum and bladder) will be governed by the ratio used and will differ depending on whether&#xD;
      acute or late toxicity is calculated. If selected an acute α / β of 10 Gy and a conservative&#xD;
      α / β for late toxicity of 3 Gy, the standard fractionation will result in an acute BED of 84&#xD;
      Gy versus 78 Gy in the hypofractionation scheme and a BED of 116.67 vs. 114.5 Gy for late&#xD;
      toxicity.&#xD;
&#xD;
      Therefore, what the investigators expect is a toxicity profile that is at least similar, if&#xD;
      not slightly better, compared to the norm-fractionated scheme of 70 Gy in 35 fractions and&#xD;
      similar rates of biochemical control and survival.&#xD;
&#xD;
      To all this is added the use of intensity modulated radiotherapy and image-guided&#xD;
      radiotherapy techniques (IGRT) that will allow the investigators to significantly reduce the&#xD;
      dose administered to risk organs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 9, 2019</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">March 2022</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>
    <intervention_model_description>This is a non-randomized prospective multicenter study of hypofractionated postoperative radiotherapy in patients diagnosed with prostate carcinoma.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment-related gastrointestinal and genitourinary acute adverse events</measure>
    <time_frame>≤90 days</time_frame>
    <description>using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale. The grades of severity from I (minimum) to V (maximum).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of late gastrointestinal and genitourinary adverse events</measure>
    <time_frame>up to 3 years</time_frame>
    <description>using the Radiation Therapy Oncology Group (RTOG) scale. The grades of severity from 1 (minimum) to 4 (maximum).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical failure-free survival</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Time elapsed between the date of inclusion in the study and biochemical failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival (locoregional and / or remote)</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Time elapsed between the date of inclusion in the study and the detection of the disease locally, regionally and / or remotely</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Time elapsed between the date of inclusion in the study and the patient's death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cause-specific survival</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Time elapsed between the date of inclusion in the study and the patient's death due to prostate cancer or toxicity derived from treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of quality of life for cancer Prostate patients</measure>
    <time_frame>at the start of treatment at 3, 12, 24 and 36 months from the end of treatment</time_frame>
    <description>Use of Expanded Prostate Cancer Index questionnaire (EPIC) 26</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>IMRT, any mode</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>External radiation therapy with 6-18 MV photons on the 62.5 Gy prostate bed in 25 2.5 Gy fractions (EQD2 71 Gy).&#xD;
Serving per fraction: 2.5 Gy Total fractions: 25 No. fractions / week: 5 Total treatment time: 5 weeks Total nominal dose: 62.5 Gy EQD3 (TRT): 68.75 Gy EQD1.5 (CaP): 71.43 Gy EQD2 (CaP): 68.75 Gy EQD10 (TRA): 65.10 Gy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>hypofractionated postoperative radiation therapy</intervention_name>
    <description>The patients included in the study will undergo intensity-modulated radiotherapy, of any modality, and image-guided (IGRT) with an emphasis on tissue preservation and administration precision through the use of devices that guarantee the stability and reproducibility of the same.</description>
    <arm_group_label>IMRT, any mode</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  ECOG 0-1 status.&#xD;
&#xD;
          -  Previous radical prostatectomy (any modality will be allowed) with or without&#xD;
             lymphadenectomy.&#xD;
&#xD;
          -  Histological confirmation of prostate adenocarcinoma in the prostatectomy specimen.&#xD;
&#xD;
          -  pT2-T3 Version 2.0, March 27, 2019&#xD;
&#xD;
          -  pN0-Nx&#xD;
&#xD;
          -  Indication of postoperative RT:&#xD;
&#xD;
               -  Adjuvant RT: pT3 and / or positive margins with PSA &lt;0.2 ng / ml. Delayed RT is&#xD;
                  considered (&gt; 6 months from the date of surgery but PSA &lt;0.2 ng / ml).&#xD;
&#xD;
               -  Rescue RT: exclusive biochemical recurrence, without evidence of macroscopic&#xD;
                  local, regional or distant disease, after surgery. Biochemical recurrence is&#xD;
                  considered PSA ≥ 0.2 ng / ml after undetectable levels, confirmed with a&#xD;
                  subsequent determination.&#xD;
&#xD;
          -  PSA levels ≤ 2 ng / ml after, at least 45 days after surgery and 30 days before&#xD;
             inclusion in the study.&#xD;
&#xD;
          -  No clinical evidence of lymph node disease. The presence will be admitted by imaging&#xD;
             tests of pelvic nodes ≤ 1 cm in its shortest axis.&#xD;
&#xD;
          -  No evidence of disease in the prostatic fossa. If you doubt by digital rectal&#xD;
             examination or CT, an MRI will be performed.&#xD;
&#xD;
          -  No evidence of distant disease after performing a thoraco-abdominal-pelvic CT scan and&#xD;
             bone scan.&#xD;
&#xD;
          -  Reasonable follow-up possibilities.&#xD;
&#xD;
          -  Ability to complete the EPIC-26 questionnaire.&#xD;
&#xD;
          -  Written informed consent prior to inclusion in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Previous pelvic radiation therapy.&#xD;
&#xD;
          -  Distant metastasis.&#xD;
&#xD;
          -  Macroscopic residual tumor.&#xD;
&#xD;
          -  PSA&gt; 2 ng / ml.&#xD;
&#xD;
          -  Pathological stage T4.&#xD;
&#xD;
          -  Lymph node involvement.&#xD;
&#xD;
          -  Pelvic or para-aortic nodules in the reevaluation images after surgery, except pelvic&#xD;
             nodes ≤ 1 cm in their shortest axis.&#xD;
&#xD;
          -  Indication of pelvic nodal RT. Version 2.0, March 27, 2019&#xD;
&#xD;
          -  Severe urinary incontinence at the time of indication for radiotherapy.&#xD;
&#xD;
          -  Uni / bilateral hip prosthesis&#xD;
&#xD;
          -  Previous tumors, except non-melanoma skin carcinoma, and which are not free of disease&#xD;
             for at least 3 years from the end of the treatment of said neoplasms. Bladder tumors&#xD;
             are excluded in all cases.&#xD;
&#xD;
          -  Genetic hyper-radio-sensitivity syndromes.&#xD;
&#xD;
          -  Chronic inflammatory bowel disease or partial or radical cystectomy for any reason.&#xD;
&#xD;
          -  Previously treated with androgen deprivation therapy for a period greater than 3&#xD;
             months.&#xD;
&#xD;
          -  Previously treated with chemotherapy for prostate cancer.&#xD;
&#xD;
          -  Life expectancy &lt;5 years or severe comorbidity: unstable angina, congestive heart&#xD;
             failure, transmural myocardial infarction requiring admission in the last 6 months,&#xD;
             active infectious process, respiratory disease requiring hospitalization, liver&#xD;
             failure (Child-Pugh Class B or C), HIV with a CD4 count &lt;200 cells / ml, kidney&#xD;
             failure requiring dialysis and immunosuppressed by other causes.&#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>ASUNCION R HERVAS, I</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ramon y Cajal University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ASUNCION R HERVAS, Investigator</last_name>
    <phone>0034649039866</phone>
    <email>ahervas.hrc@salud.madrid.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>ADELA MARIA López, Data Manager</last_name>
    <phone>0034656303686</phone>
    <email>adelamaria.lopez@salud.madrid.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital General Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <state>Adrid</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CARMEN GONZALEZ SANSEGUNDO, INVESTIGATOR</last_name>
      <phone>+34915868000</phone>
      <phone_ext>+34915868000</phone_ext>
      <email>cglezss@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>ANA ALVAREZ, INVESTIGATOR</last_name>
      <phone>+34915868000</phone>
      <phone_ext>+34915868000</phone_ext>
      <email>analvagonza@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de San Juan</name>
      <address>
        <city>San Juan</city>
        <state>Alicante</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra González Montiel, Investigator</last_name>
      <phone>+34965169400</phone>
      <email>Sandra.19792@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>ICO Badalona</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana Álvarez García, Investigator</last_name>
      <phone>+34932607733</phone>
      <email>ana.alvarez@iconcologia.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Dr. Negrin</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <state>Gran Canaria</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Ignacio Rodriguez Melcón, Investigator</last_name>
      <phone>+34928450284</phone>
      <email>nachorodriguezmelcon@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Santiago</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>La Coruña</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana María Carballo Castro, Investigator</last_name>
      <phone>+34981950000</phone>
      <email>ana.maria.carballo.castro@sergas.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Fuenlabrada</name>
      <address>
        <city>Fuenlabrada</city>
        <state>Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Begoña Caballero</last_name>
      <phone>+34916006581</phone>
      <email>begocaba@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Torrecárdenas</name>
      <address>
        <city>Almería</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carmen Cano Soler, Investigator</last_name>
      <phone>+34950016000</phone>
      <email>canosolercar@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Badajoz</name>
      <address>
        <city>Badajoz</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julia Muñoz García, Investigator</last_name>
      <phone>+34924218100</phone>
      <email>jlmunozgarcia@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>H. Sta. Cruz y San Pablo</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gemma Sancho Pardo, Investigator</last_name>
      <phone>+34932919000</phone>
      <email>gsancho@santpau.cat</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Instituto Oncológico IMQ</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clara Eito Valdovinos, Investigator</last_name>
      <phone>+34944755000</phone>
      <email>c.eito@imq.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario San Cecilio</name>
      <address>
        <city>Granada</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Lazo Prados, Investigator</last_name>
      <phone>0034958023000</phone>
      <email>anlaparados@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón Y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>2834</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ASUNCIÓN R HERVAS, Investigator</last_name>
      <email>ahervas.hrc@salud.madrid.org</email>
    </contact>
    <contact_backup>
      <last_name>ADELA MARIA López, Data Manager</last_name>
      <phone>0034656303686</phone>
      <email>adelamaria.lopez@salud.madrid.org</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Fundación Jimenez Díaz 1</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jesús Olivera, Investigator</last_name>
      <phone>+34915504800</phone>
      <email>jolivera@fjd.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fundación Jiménez Díaz 2</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Walter Vasquez Rivas, Investigator</last_name>
      <phone>+34915494058</phone>
      <email>walter.vasquez@quironsalud.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de La Princesa</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Almudena Zapatero, Investigator</last_name>
      <phone>+34915202315</phone>
      <email>almudena.zapatero@salud.madrid.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital La Luz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis L Guerrero Gómez, Investigator</last_name>
      <phone>+34914521900</phone>
      <email>leoguerrero01@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Quirón</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felipe Couñago Lorenzo, Investigator</last_name>
      <phone>+34914521900</phone>
      <email>fcounago@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Ruber Internacional</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aurora Rodríguez Pérez, INVESTIGATOR</last_name>
      <phone>0034913875288</phone>
      <email>aurora.rodriguezp@ruberinternacional.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marta Barrado Los Arcos, Investigator</last_name>
      <phone>+34848428482</phone>
      <email>marta.barrado.losarcos@navarra.es</email>
    </contact>
    <contact_backup>
      <last_name>Margarita Illas Pérez-Mosso, Investigator</last_name>
      <phone>+34848428482</phone>
      <email>margarita.illas.perezmosso@navarra.es</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Grupo de Investigación Clínica en Oncología Radioterapia</investigator_affiliation>
    <investigator_full_name>Asunción Hervas</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Radiotherapy, prostate cancer</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/NCT04484038
org study id: HYPORT-ES
nct id: NCT04484038
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate, in patients diagnosed with prostate cancer who
      undergo radical prostatectomy and who require postoperative radiotherapy, tolerance in terms
      of acute and chronic GU and GI toxicity and efficacy in terms of biochemical control and
      survival, as well as of quality of life, from a hypofractional external radiotherapy scheme,
      increasing the dose per fraction in a shorter period of time.
What the investigators present in this study is a hypofractionation scheme of 62.5 Gy in 25
      daily fractions of 2.5 Gy / day, which was chosen to provide a biological equivalent dose
      (BED) of 166.67 Gy, comparable to the 163 Gy administered with a scheme Normally divided up
      to 70 Gy in daily fractions of 2 Gy / day Version 2.0, March 27, 2019

      (assuming an α / β ratio of 1.5 Gy for prostate cancer). The BED in risk organs (mainly
      rectum and bladder) will be governed by the ratio used and will differ depending on whether
      acute or late toxicity is calculated. If selected an acute α / β of 10 Gy and a conservative
      α / β for late toxicity of 3 Gy, the standard fractionation will result in an acute BED of 84
      Gy versus 78 Gy in the hypofractionation scheme and a BED of 116.67 vs. 114.5 Gy for late
      toxicity.

      Therefore, what the investigators expect is a toxicity profile that is at least similar, if
      not slightly better, compared to the norm-fractionated scheme of 70 Gy in 35 fractions and
      similar rates of biochemical control and survival.

      To all this is added the use of intensity modulated radiotherapy and image-guided
      radiotherapy techniques (IGRT) that will allow the investigators to significantly reduce the
      dose administered to risk organs.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a non-randomized prospective multicenter study of hypofractionated postoperative radiotherapy in patients diagnosed with prostate carcinoma.
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of treatment-related gastrointestinal and genitourinary acute adverse events
time frame: ≤90 days
description: using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale. The grades of severity from I (minimum) to V (maximum).
measure: Incidence of late gastrointestinal and genitourinary adverse events
time frame: up to 3 years
description: using the Radiation Therapy Oncology Group (RTOG) scale. The grades of severity from 1 (minimum) to 4 (maximum).
measure: Biochemical failure-free survival
time frame: up to 3 years
description: Time elapsed between the date of inclusion in the study and biochemical failure
measure: Disease-free survival (locoregional and / or remote)
time frame: up to 3 years
description: Time elapsed between the date of inclusion in the study and the detection of the disease locally, regionally and / or remotely
measure: Overall survival
time frame: up to 3 years
description: Time elapsed between the date of inclusion in the study and the patient's death from any cause
measure: Cause-specific survival
time frame: up to 3 years
description: Time elapsed between the date of inclusion in the study and the patient's death due to prostate cancer or toxicity derived from treatment
measure: Assessment of quality of life for cancer Prostate patients
time frame: at the start of treatment at 3, 12, 24 and 36 months from the end of treatment
description: Use of Expanded Prostate Cancer Index questionnaire (EPIC) 26
arm group label: IMRT, any mode
arm group type: Other
description: External radiation therapy with 6-18 MV photons on the 62.5 Gy prostate bed in 25 2.5 Gy fractions (EQD2 71 Gy).
Serving per fraction: 2.5 Gy Total fractions: 25 No. fractions / week: 5 Total treatment time: 5 weeks Total nominal dose: 62.5 Gy EQD3 (TRT): 68.75 Gy EQD1.5 (CaP): 71.43 Gy EQD2 (CaP): 68.75 Gy EQD10 (TRA): 65.10 Gy
intervention type: Radiation
intervention name: hypofractionated postoperative radiation therapy
description: The patients included in the study will undergo intensity-modulated radiotherapy, of any modality, and image-guided (IGRT) with an emphasis on tissue preservation and administration precision through the use of devices that guarantee the stability and reproducibility of the same.
arm group label: IMRT, any mode
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ASUNCION R HERVAS, I
role: Principal Investigator
affiliation: Ramon y Cajal University Hospital
last name: ASUNCION R HERVAS, Investigator
phone: 0034649039866
email: ahervas.hrc@salud.madrid.org
last name: ADELA MARIA López, Data Manager
phone: 0034656303686
email: adelamaria.lopez@salud.madrid.org
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country: Spain
responsible party type: Principal Investigator
investigator affiliation: Grupo de Investigación Clínica en Oncología Radioterapia
investigator full name: Asunción Hervas
investigator title: MD
mesh term: Prostatic Neoplasms
sharing ipd: No