STUDY WITH RADIOTHERAPY TREATMENT WITH ANDROGEN DEPRIVATION THERAPY (ADT) WITH OR WITHOUT ABIRATERONE ACETATE AND PREDNISONE IN CRPC
- Conditions
- OCALLY ADVANCED VERY HIGH-RISK PROSTATE CANCERMedDRA version: 17.1Level: LLTClassification code 10029002Term: Neoplasm of the prostateSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002071-29-IT
- Lead Sponsor
- DIPARTIMENTO DI ONCOLOGIA MEDICA USL8
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 172
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to determine whether, following an integrated RT approach, Abiraterone Acetate in ombination with low-dose prednisone and ADT is superior to ADT alone in improving EFS in hormone naïve subjects diagnosed with very high-risk prostate cancer.;Secondary Objective: Safety; Biochemical Response Rate (PSA Response); overall survival, time to death due to prostate cancer; Biological end-points.;Primary end point(s): The primary efficacy endpoint is event-free survival (EFS) and will be measured from the date of randomization to the first occurrence of biochemical (PSA) relapse (bNED), local failure, distant recurrence or death (whatever the cause).<br>EFS time of patients living without any event at the end of the study will be censored on the last date a patient is known to be alive or lost to follow-up.;Timepoint(s) of evaluation of this end point: 3 MONTHS SINCE STUDY END
- Secondary Outcome Measures
Name Time Method