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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
Hospital General Gregorio Marañón
Madrid, Adrid, Spain
RECRUITINGHospital Universitario de San Juan
Incidence of treatment-related gastrointestinal and genitourinary acute adverse events
using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale. The grades of severity from I (minimum) to V (maximum).
Time frame: ≤90 days
Incidence of late gastrointestinal and genitourinary adverse events
using the Radiation Therapy Oncology Group (RTOG) scale. The grades of severity from 1 (minimum) to 4 (maximum).
Time frame: up to 3 years
Biochemical failure-free survival
Time elapsed between the date of inclusion in the study and biochemical failure
Time frame: up to 3 years
Disease-free survival (locoregional and / or remote)
Time elapsed between the date of inclusion in the study and the detection of the disease locally, regionally and / or remotely
Time frame: up to 3 years
Overall survival
Time elapsed between the date of inclusion in the study and the patient's death from any cause
Time frame: up to 3 years
Cause-specific survival
Time elapsed between the date of inclusion in the study and the patient's death due to prostate cancer or toxicity derived from treatment
Time frame: up to 3 years
Assessment of quality of life for cancer Prostate patients
Use of Expanded Prostate Cancer Index questionnaire (EPIC) 26
Time frame: at the start of treatment at 3, 12, 24 and 36 months from the end of treatment
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San Juan, Alicante, Spain
ICO Badalona
Badalona, Barcelona, Spain
RECRUITINGHospital Dr. Negrin
Las Palmas de Gran Canaria, Gran Canaria, Spain
RECRUITINGHospital Universitario de Santiago
Santiago de Compostela, La Coruña, Spain
RECRUITINGHospital de Fuenlabrada
Fuenlabrada, Madrid, Spain
RECRUITINGHospital Universitario Torrecárdenas
Almería, Spain
RECRUITINGHospital Universitario de Badajoz
Badajoz, Spain
RECRUITINGH. Sta. Cruz y San Pablo
Barcelona, Spain
RECRUITINGInstituto Oncológico IMQ
Bilbao, Spain
RECRUITING...and 9 more locations