PROSTATE CANCER PATIENTS WITH HIGH RISK
Conditions
Interventions
Trade Name: ZYTIGA
Product Name: ZYTIGA
Pharmaceutical Form: Tablet
Sponsors
AOU SAN LUIGI GONZAGA - SCDU ONCOLOGIA MEDICA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Signature of the written informed consent and consent to the use of personal data • Age> 40 years, male • histological or cytological diagnosis of carcinoma of the prostate acinar type • absent lymph node involvement at diagnosis (as assessed by CT or MRI scan method) • Representative sample of tumor tissue biopsy material of> 5% of the total tissue sample (calculated as total mm of tumor tissue / mm total of frustules in examination) • Representative sample of tumor tissue evident on section area greater than 0.5 cm2 of material surgical prostatectomy (if the disease was multifocal it is necessary that the focus of larger size to meet the criteria) • high-risk disease defined as Gleason score> = 8 and / or PSA value> 20 ng / ml and / or disease> = cT3 (D'Amico classification) • Patients eligible radical prostatectomy 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: • Special histological types of carcinoma of the prostate • PSA> 100 ng / ml • Concomitant treatment with other antineoplastic agents including endocrine therapies experimental • Treatment with any investigational drug within 30 days prior to enrollment • Patients with a history of severe Hypersensitivity to any component of the drugs used in the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Evaluate the effect of short-term treatment with abiraterone acetate and LHRH analogue on pathological complete response + almost complete (residual disease <5mm) after radical prostatectomy;Secondary Objective: • Evaluate the rate of pathologic complete response after radical prostatectomy • Evaluate the response rate serum (PSA) • To evaluate the effect of neoadjuvant hormonal treatment on serum concentrations of testosterone and androgens • Assess changes in serum markers of bone turnover: bone isoenzyme of bone alkaline phosphatase (BSAP) and carboxy-terminal telopeptide of type I collagen (CTX) • To evaluate the effect of neoadjuvant hormonal treatment on the expression of tissue protein and gene expression biomarkers selected from different arms of the study and comparison of surgical and biopsy material of the same patients;Primary end point(s): Evaluate the effect of short-term treatment with abiraterone acetate and LHRH analogue on pathological complete response + almost complete (residual disease <5mm) after radical prostatectomy.;Timepoint(s) of evaluation of this end point: NOT APPLICABLE | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate the rate of pathologic complete response after radical prostatectomy • Evaluate the response rate serum (PSA) • To evaluate the effect of neoadjuvant hormonal treatment on serum concentrations of testosterone and androgens • Assess changes in serum markers of bone turnover: bone isoenzyme of bone alkaline phosphatase (BSAP) and carboxy-terminal telopeptide of type I collagen (CTX) • To evaluate the effect of neoadjuvant hormonal treatment on the expression of tissue protein and gene expression biomarkers selected from different arms of the study and comparison of surgical and biopsy material of the same patients;Timepoint(s) of evaluation of this end point: NOT APPLICABLE | — |
Countries
Italy
Contacts
Public ContactPROF. GIORGIO VITTORIO SCAGLIOTTI
SCDU-ONCOLOGIA MEDICA - AOU SAN LUIGI GONZAGA
Outcome results
None listed