LOCALLY ADVANCED VERY HIGH-RISK PROSTATE CANCER MedDRA version: 17.1 Level: LLT Classification code 10029002 Term: Neoplasm of the prostate System Organ Class: 100000004864
Conditions
Interventions
Trade Name: zytiga
Product Name: Abiraterone acetato
Pharmaceutical Form: Tablet
Trade Name: deltacortene
Product Name: PREDNISONE
Pharmaceutical Form: Tablet
Trade Name: CASODEX
Product Name: BICAL
Sponsors
DIPARTIMENTO DI ONCOLOGIA MEDICA USL8
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS) will be measured from the date of randomization to the date of death (whatever the cause). Survival time of living patients will be censored on the last date a patient is known to be alive or lost to follow-up. Time to death due to prostate cancer will be measured from the date of randomization to the date of death caused by prostate cancer. Observation time of patients dead for causes other then prostate cancer, or living 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. Other efficacy endpoints Biochemical response rate (PSA Response), will be evaluated according to the PCWG2 Criteria. Safety (RTOG and NCI CTC Criteria). Biological end-points.;Timepoint(s) of evaluation of this end point: Overall survival (OS) will be measured from the date of randomization to the date of death (whatever the cause). Survival time of living patients will be censored on the last date a patient is known to be alive or lost to follow-up. Time to death due to prostate cancer will be measured from the date of randomization to the date of death caused by prostate cancer. Observation time of patients dead for causes other then prostate cancer, or living 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. Other efficacy endpoints Biochemical response rate (PSA Response), will be evaluated according to the PCWG2 Criteria. Safety (RTOG and NCI CTC Criteria). Biological end-points. | — |
Countries
Italy
Contacts
Public ContactU.O ONCOLOGIA MEDICA
DIPARTIMENTO DI ONCOLOGIA MEDICA USL8
Outcome results
None listed