A RANDOMIZED PROSPECTIVE MULTICENTRE PHASE II STUDY OF ANDROGEN DEPRIVATION THERAPY (ADT) PLUS RADIOTHERAPY WITH OR WITHOUT ABIRATERONE ACETATE AND PREDNISONE IN LOCALLY ADVANCED VERY HIGH-RISK PROSTATE CANCER:ITT012 ELISA” STUDY - ITT012ELISA”

DIPARTIMENTO DI ONCOLOGIA MEDICA USL80 个研究点目标入组 172 人开始时间: 2014年11月4日最近更新: 2018年2月26日

适应症

试验速览

暂无简介。

•1.Signed informed consent
•2.Histological diagnosis of prostate adenocarcinoma (with Gleason Score and centralized review)
•3.Hormone-Naive Very High-Risk Disease, defined as patients with Very High Risk Prostate Cancer”, deriving, accordingly to the NCCN definition, to the following Groups:
•A) Patients with multiple (at least two) Risk parameters (stages T3a, N0, M0 / Gleason Score 8-10 / Baseline PSA > 20ng/ml) of the High-Risk localized disease” group* (*who, according to note c” may be shifted into the Highest Risk group)
•B) Patients with a Locally Advanced Disease (a stage T3b-T4, N0 M0)
•4.No other prior or concomitant anti-cancer therapy.
•5.Age between 18 and 80 years
•6.Life expectancy > 6 months
•7.PS = 1 (ECOG scale)
•8.ANC = 1.5 x 109/L; PLT = 100 x 109/L; Hb =10 g/dl
•9.ASAT and ALAT =1.5 times the upper normal limit (UNL) of the institutions; serum bilirubin = 1 time the UNL;
•10.Creatinine =1.5 times the UNL
•11.Patients must be accessible for treatment and follow up
•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 7
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•1.Distant Metastatic Sites or lymph node involvement
•2.Previous malignancies, except for basal cell skin cancer adequately treated or any other cancer from which the patient has been disease-free for = 5 years
•3.Any of the concomitant illness or medical condition indicated below:
•Serious respiratory or cardiovascular disease (such as: congestive heart failure; previous history of myocardial infarction, angina pectoris or deep venous thrombosis within 6 months from study entry, uncontrolled hypertension or uncontrolled arrhythmias)
•Unstable diabetes mellitus, peptic ulcer or other contraindications to corticosteroids.
•Active infections.
•Significant neurological or psychiatric disorders.
•4.Participation in clinical trials with other experimental agents within 30 days of study entry or concomitant treatment with other experimental drug

发起方

DIPARTIMENTO DI ONCOLOGIA MEDICA USL8