E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PROSTATE CANCER PATIENTS WITH HIGH RISK |
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E.1.1.1 | Medical condition in easily understood language |
PROSTATE CANCER PATIENTS WITH HIGH RISK |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• 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 |
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E.2.2 | Secondary objectives of the trial |
• 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
arm A treatment, LH-RH analogue; arm B treatment, LH-RH anologue with abiraterone acetate |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
arm A treatment, LH-RH analogue; arm B treatment, LH-RH anologue with abiraterone acetate |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |