Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma

July 21, 2020 updated by: Asunción Hervas, Grupo de Investigación Clínica en Oncología Radioterapia
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Almería, Spain
        • Recruiting
        • Hospital Universitario Torrecárdenas
        • Contact:
      • Badajoz, Spain
        • Recruiting
        • Hospital Universitario de Badajoz
        • Contact:
      • Barcelona, Spain
        • Recruiting
        • H. Sta. Cruz y San Pablo
        • Contact:
      • Bilbao, Spain
        • Recruiting
        • Instituto Oncológico IMQ
        • Contact:
          • Clara Eito Valdovinos, Investigator
          • Phone Number: +34944755000
          • Email: c.eito@imq.es
      • Granada, Spain
        • Recruiting
        • Hospital Universitario San Cecilio
        • Contact:
      • Madrid, Spain
      • Madrid, Spain, 2834
      • Madrid, Spain
        • Recruiting
        • Fundación Jimenez Díaz 1
        • Contact:
          • Jesús Olivera, Investigator
          • Phone Number: +34915504800
          • Email: jolivera@fjd.es
      • Madrid, Spain
        • Recruiting
        • Fundación Jiménez Díaz 2
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Hospital La Luz
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Hospital Quirón
        • Contact:
          • Felipe Couñago Lorenzo, Investigator
          • Phone Number: +34914521900
          • Email: fcounago@gmail.com
      • Madrid, Spain
      • Pamplona, Spain
    • Adrid
      • Madrid, Adrid, Spain
        • Recruiting
        • Hospital General Gregorio Marañón
        • Contact:
          • CARMEN GONZALEZ SANSEGUNDO, INVESTIGATOR
          • Phone Number: +34915868000 +34915868000
          • Email: cglezss@gmail.com
        • Contact:
    • Alicante
      • San Juan, Alicante, Spain
        • Recruiting
        • Hospital Universitario de San Juan
        • Contact:
    • Barcelona
      • Badalona, Barcelona, Spain
    • Gran Canaria
      • Las Palmas de Gran Canaria, Gran Canaria, Spain
        • Recruiting
        • Hospital Dr. Negrín
        • Contact:
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain
    • Madrid
      • Fuenlabrada, Madrid, Spain
        • Recruiting
        • Hospital De Fuenlabrada
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • ECOG 0-1 status.
  • Previous radical prostatectomy (any modality will be allowed) with or without lymphadenectomy.
  • Histological confirmation of prostate adenocarcinoma in the prostatectomy specimen.
  • pT2-T3 Version 2.0, March 27, 2019
  • pN0-Nx

  • Indication of postoperative RT:

    • Adjuvant RT: pT3 and / or positive margins with PSA <0.2 ng / ml. Delayed RT is considered (> 6 months from the date of surgery but PSA <0.2 ng / ml).
    • Rescue RT: exclusive biochemical recurrence, without evidence of macroscopic local, regional or distant disease, after surgery. Biochemical recurrence is considered PSA ≥ 0.2 ng / ml after undetectable levels, confirmed with a subsequent determination.
  • PSA levels ≤ 2 ng / ml after, at least 45 days after surgery and 30 days before inclusion in the study.
  • No clinical evidence of lymph node disease. The presence will be admitted by imaging tests of pelvic nodes ≤ 1 cm in its shortest axis.
  • No evidence of disease in the prostatic fossa. If you doubt by digital rectal examination or CT, an MRI will be performed.
  • No evidence of distant disease after performing a thoraco-abdominal-pelvic CT scan and bone scan.
  • Reasonable follow-up possibilities.
  • Ability to complete the EPIC-26 questionnaire.
  • Written informed consent prior to inclusion in the study.

Exclusion Criteria:

  • - Previous pelvic radiation therapy.
  • Distant metastasis.
  • Macroscopic residual tumor.
  • PSA> 2 ng / ml.
  • Pathological stage T4.
  • Lymph node involvement.
  • Pelvic or para-aortic nodules in the reevaluation images after surgery, except pelvic nodes ≤ 1 cm in their shortest axis.
  • Indication of pelvic nodal RT. Version 2.0, March 27, 2019
  • Severe urinary incontinence at the time of indication for radiotherapy.
  • Uni / bilateral hip prosthesis
  • Previous tumors, except non-melanoma skin carcinoma, and which are not free of disease for at least 3 years from the end of the treatment of said neoplasms. Bladder tumors are excluded in all cases.
  • Genetic hyper-radio-sensitivity syndromes.
  • Chronic inflammatory bowel disease or partial or radical cystectomy for any reason.
  • Previously treated with androgen deprivation therapy for a period greater than 3 months.
  • Previously treated with chemotherapy for prostate cancer.
  • Life expectancy <5 years or severe comorbidity: unstable angina, congestive heart failure, transmural myocardial infarction requiring admission in the last 6 months, active infectious process, respiratory disease requiring hospitalization, liver failure (Child-Pugh Class B or C), HIV with a CD4 count <200 cells / ml, kidney failure requiring dialysis and immunosuppressed by other causes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: IMRT, any mode

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
Radiation: hypofractionated postoperative radiation therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-related gastrointestinal and genitourinary acute adverse events
Time Frame: ≤90 days
using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale. The grades of severity from I (minimum) to V (maximum).
≤90 days
Incidence of late gastrointestinal and genitourinary adverse events
Time Frame: up to 3 years
using the Radiation Therapy Oncology Group (RTOG) scale. The grades of severity from 1 (minimum) to 4 (maximum).
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical failure-free survival
Time Frame: up to 3 years
Time elapsed between the date of inclusion in the study and biochemical failure
up to 3 years
Disease-free survival (locoregional and / or remote)
Time Frame: up to 3 years
Time elapsed between the date of inclusion in the study and the detection of the disease locally, regionally and / or remotely
up to 3 years
Overall survival
Time Frame: up to 3 years
Time elapsed between the date of inclusion in the study and the patient's death from any cause
up to 3 years
Cause-specific survival
Time Frame: up to 3 years
Time elapsed between the date of inclusion in the study and the patient's death due to prostate cancer or toxicity derived from treatment
up to 3 years
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
Use of Expanded Prostate Cancer Index questionnaire (EPIC) 26
at the start of treatment at 3, 12, 24 and 36 months from the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Investigación Clínica en Oncología Radioterapia

Investigators

  • Principal Investigator: ASUNCION R HERVAS, I, Ramon y Cajal University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 9, 2019

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

March 1, 2025

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (ACTUAL)

July 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYPORT-ES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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