Radioterapia externa postoperatoria combinada con tratamiento hormonal adyuvante y concomitante frente a la radioterapia externa postoperatoria como tratamiento único en el carcinoma de próstata estadio pT3a-b R0-1 N0M0 / pT2R1 N0M0 y con puntuación de Gleason 5-10. Estudio fase III.(Post-operative external radiotherapy combined with concomitant and adjuvant hormonal treatment versus post-operative external radiotherapy alone in pathological stage pT3a-b R0-1 N0M0 / pT2R1 N0M0, Gleason score 5-10 prostatic carcinoma. A Phase III study)

• Conditions: n carcinoma de próstata estadio pT3a-b R0-1 N0M0 / pT2R1 N0M0 y con puntuación de Gleason 5-10.(Prostatic carcinoma with pathological stage pT3a-b R0-1 N0M0 / pT2R1 N0M0, Gleason score 5-10); MedDRA version: 9.1Level: LLTClassification code 10036955Term: Prostatic carcinoma

• Registration Number: EUCTR2006-002772-17-ES
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-04
• Last Update Posted: 17 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 600

Inclusion Criteria

-Pacientes con estadio clínico cT1-2-3 a N0 M0 con cáncer de próstata (UICC TNM 2002) comprobado después de un estadiaje que incluya exploración física, radiografía de tórax, gammagrafía ósea, TC o RM abdomino-pélvica.
-PSA preoperatorio < de multiplicar por 5 el límite superior normal
-Prostatectomía: todas las técnicas permitidas ( retropúbica, laparoscópica o perineal)
Tras la prostatectomía:
-Gleason 5-10
-Estadio pT2R1 (margen positivo quirúrgico con una sección tumoral como mínimo de 2 mm) o pT3a-b ( márgenes negativos o positivos)
-Ganglios negativos (pN0) por muestra ganglionar o por linfadenectomía. Un estado ganglionar desconocido (pNx) no está permitido a no ser que el paciente tenga un cT1 con PSA menor de 10 y Gleason menor de 7 con biopsias positivas en menos del 50%, con un total de biopsias de cómo mínimo 12.
-PSA pos-op no detectable en los tres primeros meses tras cirugía
-Edad < 80 años
-PS OMS 0-1
-Hemograma normal dentro de las dos semanas previas a la aleatorización: Hemoglobina > 110 g/l, leucocitos > 3x10?9/l, plaquetas > 100 x 10?9/l
-Consentimiento informado por escrito antes de la aleatorización

(?Patients with clinical stage cT1-2-3a N0M0 prostate cancer (UICC TNM 2002) assessed after a preoperative work-up including physical examination, chest X ray, bone scan, CT-scan or MRI of the entire pelvis and abdomen.
?Pre-operative PSA ≤ 5 x upper limit of normal range.
?Presenting after radical prostatectomy (all techniques allowed: retropubic, laparoscopic or perineal) with
?Gleason score 5-10.
?Pathologic stage pT2R1 (positive surgical margins with at least a tumor trans-section higher than 2 mm) or pT3a-b (irrespective of margin status).
?Negative lymph node (LN) status (pN0) by LN sampling or LN dissection. Unknown pathological LN status (pNx, i.e., omission of LN sampling or LN dissection) is not allowed except for patients classified as cT1c with baseline PSA < 10ng/ml and Gleason score < 7 and positive core biopsies < 50%, provided the total number of random biopsies is at least 12.
?Undetectable post-operative PSA (PSA is below the detection level of the laboratory) within 3 months of surgery.
?Age ≤ 80 years.
?WHO performance status 0-1.
?Normal organ functions as shown by all of the following (measured within 2 weeks prior to randomization): hemoglobin ≥ 110 g/l, WBC ≥3 x 109/l, platelet count ≥ 100 x 109/l.

?Before randomization, written informed consent must be given by the patient, according to ICH/GCP, and national/local regulations.)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-RT previa ò orquiectomía previa
-Quimioterapia previa en los últimos 5 años
-Tratamiento hormonal previo excepto neoadyuvante < 3 meses
-Otras neoplasias excepto carcinoma basocelular de la piel u otras sin evidencia de enfermedad en los últimos 5 años.
-Trastorno psico social, familiar, sicológico o geográfico que impidan cumplir bien el protocolo o el seguimiento.

(?Prior pelvic irradiation, prior bilateral orchiectomy.
?Prior chemotherapy within the 5 years prior to randomization.
?Prior hormonal treatment except neoadjuvant and lasting ≤3 months.
?Other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease free for at least 5 years.
?Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigar el potencial beneficio de un tratamiento adyuvante combinado de tratamiento corto de privación androgénica con radioterapia (RT) post-operatoria comparado con RT sola, para mejorar el intervalo libre de progresión bioquímica en pacientes que han sido tratados con prostatectomía radical con estadios cT1-2-3a N0M0 por cáncer de próstata con PSA basal < 5 veces el valor superior normal y que en el estadio patológico sean pT2 R1/pT3a-b R0-1 N0 M0, Gleason 5-10 y PSA post-operatorio indetectable<br><br>(To investigate the potential benefit, in terms of biochemical progression free survival, of a combined adjuvant treatment consisting of short term androgen suppression in addition to postoperative RT in comparison to post-operative RT alone.);Secondary Objective: NA;Primary end point(s): Supervivencia sin progresión bioquímica <br><br>(The primary trial endpoint is biochemical progression-free survival)