EUCTR2008-000422-39-DE进行中（未招募）不适用
A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study theEfficacy and Safety of Bicalutamide With or Without Deforolimus in Men WithAsymptomatic, Metastatic Castrate-Resistant Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •1. Patient has histologically confirmed adenocarcinomas of the prostate.
- •2. Archival pathological material is available for submission to central laboratory.
- •3. Patient has evidence of metastatic disease at protocol entry or at the time of prior hormonal manipulation, determined radiographically by the presence of at least 2 bone scan lesions consistent with metastases or abdominal/pelvic lymph nodes > 2 cm on longest axial measurement. Solitary or ambiguous bone lesions should be confirmed with plain radiographs or magnetic resonance imaging (MRI).
- •4. Patient has evidence of disease progression despite castrate levels of testosterone (< 50 ng/dl) following orchiectomy or during therapy with a luteinizing hormone releasing hormone (LHRH) agonist or antagonist (with or without an anti-androgen). Evidence of disease progression must include one of the following:
- •a) Levels of PSA are defined as increasing when at least three consecutive measurements, obtained at least one week apart, show increases. (The minimum starting PSA level for trial entry is 7 ng/mL.)
- •b) Progressive lymph node disease is defined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The longest diameter of any node must measure at least 2 cm on spiral computed tomography (CT) to qualify as a target lesion.
- •c) Worsening bone scan is defined as an increase of 2 or more lesions from a previous bone scan. Solitary or ambiguous bone lesions should be confirmed with plain radiographs or MRI.
- •5. Patient has a PSA >= 7 ng/ml.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient has received bicalutamide, flutamide, nilutamide or cyproterone within the past 12 months, except for use of less than 30 days duration during the initiation of LHRH analog therapy.
- •2. Patient has received prior chemotherapy for metastatic prostate cancer.
- •3. Patient has previously received rapamycin or rapamycin analogs, including deforolimus, temsirolimus, or everolimus.
- •4. Patient is receiving corticosteroids administered at doses greater than those used for normal replacement therapy. .
- •5. Patient is receiving an opioid or narcotic analgesic prescribed for pain due to prostate cancer.
- •6. In the opinion of the investigator, the patient has pain related to metastatic prostate cancer that warrants the initiation of chemotherapy.
研究者
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