Multicenter clinical trial, randomized phase II window of opportunity which aims to test the biological activity of abiraterone acetate administered as neoadjuvant therapy in patients with prostate cancer at high risk. (multicenter study).

• Conditions: PROSTATE CANCER PATIENTS WITH HIGH RISK; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000674-30-IT
• Lead Sponsor: AOU SAN LUIGI GONZAGA - SCDU ONCOLOGIA MEDICA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-17
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified