EUCTR2005-001602-76-DE进行中（未招募）不适用
Phase III clinical trial comparing treatments of hormone-refractory prostate cancer (HRPC) with Docetaxel: continuous treatment vs. intermittent repetition of treatment after progression. - PRINCE
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •adenocarcinoma of the prostate confirmed by histology or cytology
- •metastasized adenocarcinoma of the prostate that is refractory to hormone
- •treatment, ie, that does no longer respond to hormone therapy and/or the current
- •treatment with estramustine
- •documented progression under the last therapy (definite PSA-increase that is
- •confirmed by 2 subsequent measurements separated by at least 2 weeks, or
- •increase of measurable lesions by at least 25% that is confirmed by radiological
- •measurements)
- •previous hormone therapy
- •ECOG performance status <= 2 (Karnofsky index >= 60%)
- •adequate hematological, cardial and hepatic function defined by the following
- •parameters:
- •- absolute neutrophil count >= 2 x 109/l
- •- thrombocytes >= 100 x 109/l
- •- hemoglobin >=10 g/dl (6.2 mmol/l)
- •- total serum bilirubin <= ULN
- •- AST (SGOT) and ALT (SGPT) <= 1.5 x ULN
- •- alkaline phosphatase <= 5 x ULN
- •life expectancy >= 12 weeks
- •written informed consent
- •age >= 18 years
- •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
- •previous therapy with isotopes
- •previous chemotherapy (except estramustine)
- •radiotherapy in the 4 weeks prior to enrollment
- •previous radiotherapy if this concerned all lesions that are used for the evaluation
- •of tumor response
- •previous radiotherapy if this concerned more than 25% of bone marrow
- •previous or concomitant neoplasm (except curatively treated in situ carcinoma and
- •basal cell carcinomas of the skin as well as curatively treated neoplasms without
- •recurrence in the 5 years prior to enrollment
- •previous or current cerebral metastases or leptomeningeal involvement
- •current peripheral neuropathy >= grade 2 (CTCAE 3.0)
- •renal inusufficiancy requiring dialysis
- •chronic diarrhea (now or in medical history)
- •other relevant concomitant diseases:
- •a) congestive heart failure or uncontrolled angina pectoris, previous myocardial
- •infarction within 6 months prior to enrollment, uncontrolled arterial
- •hypertension or arrhythmias
- •b) known significant neurological or psychiatric diseases including dementia and
- •epileptic seizures
- •c) active infections requiring intravenous administration of antibiotics
- •d) ulcerations, not stable diabetes mellitus or other contraindications with regard
- •to the administration of high doses of corticosteroids
- •e) untreated vena-cava-syndrome
- •f) known ascites or pericardial effusion
- •g) known symptomatic pleural effusion that requires tapping
- •concomitant treatment with other anti-tumor therapies except LHRH-agonists in a
- •constant dose (for at least 4 weeks prior to enrollment) which should be continued
- •participation in a clinical trial within 30 days prior to enrollment
- •being anable to complie with therapy and investigations
研究者
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