EUCTR2013-000674-30-IT进行中（未招募）不适用
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). - abiraterone neoadiuvante
AOU SAN LUIGI GONZAGA - SCDU ONCOLOGIA MEDICA0 个研究点开始时间: 2013年5月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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
研究者
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