Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Carcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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

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.

hypofractionated postoperative radiation therapy

ASUNCION R HERVAS, Investigator

ADELA MARIA López, Data Manager

CARMEN GONZALEZ SANSEGUNDO, INVESTIGATOR

ANA ALVAREZ, INVESTIGATOR

Sandra González Montiel, Investigator

Ana Álvarez García, Investigator

Juan Ignacio Rodriguez Melcón, Investigator

Ana María Carballo Castro, Investigator

Begoña Caballero

Carmen Cano Soler, Investigator

Julia Muñoz García, Investigator

Gemma Sancho Pardo, Investigator

Clara Eito Valdovinos, Investigator

Antonio Lazo Prados, Investigator

ASUNCIÓN R HERVAS, Investigator

Jesús Olivera, Investigator

Walter Vasquez Rivas, Investigator

Almudena Zapatero, Investigator

Luis L Guerrero Gómez, Investigator

Felipe Couñago Lorenzo, Investigator

Aurora Rodríguez Pérez, INVESTIGATOR

Marta Barrado Los Arcos, Investigator

Margarita Illas Pérez-Mosso, Investigator

ASUNCION R HERVAS, I

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.

This is a non-randomized prospective multicenter study of hypofractionated postoperative radiotherapy in patients diagnosed with prostate carcinoma.

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

using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale. The grades of severity from I (minimum) to V (maximum).

using the Radiation Therapy Oncology Group (RTOG) scale. The grades of severity from 1 (minimum) to 4 (maximum).

Time elapsed between the date of inclusion in the study and biochemical failure

Time elapsed between the date of inclusion in the study and the detection of the disease locally, regionally and / or remotely

Time elapsed between the date of inclusion in the study and the patient's death from any cause

Time elapsed between the date of inclusion in the study and the patient's death due to prostate cancer or toxicity derived from treatment

Use of Expanded Prostate Cancer Index questionnaire (EPIC) 26

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma	NCT04484038	Prostate Cancer	hypofractionate...	18 Years -	Grupo de Investigación Clínica en Oncología Radioterapia
Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma	NCT04484038	Prostate Cancer	hypofractionate...	18 Years -	Grupo de Investigación Clínica en Oncología Radioterapia
Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma	NCT04484038	Prostate Cancer	hypofractionate...	18 Years -	Grupo de Investigación Clínica en Oncología Radioterapia

Spots Global Cancer Trial Database for radiotherapy, prostate cancer