EUCTR2013-003118-42-SE进行中（未招募）1 期
A three arm randomized, open-label Phase II study of radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) versus 80 kBq/kg (88 kBq/kg after implementation of NIST update), and versus 50 kBq/kg (55 kBq/kg after implementation of NIST update) in an extended dosing schedule in subjects with castration-resistant prostate cancer metastatic to the bone
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 391
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
入选标准
- •- Histologically or cytologically confirmed adenocarcinoma of the prostate
- •- Castration-resistant disease defined as:
- •a Serum testosterone level: = 50 ng/dL (1.7 nmol/L)
- •b Bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (LHRH) agonist or antagonist, or polyestradiol phosphate
- •c Serum PSA progression defined as 2 subsequent increases in PSA over
- •a previous reference value, with a PSA value of = 2 ng/mL at the time of the second increase
- •Radiographic evidence of disease progression in bone (according to Prostate Cancer Clinical Trials Working Group 2 [PCWG2] criteria) with or without PSA progression
- •- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. In case of ECOG PS 2, the PS has to be due to metastatic prostate cancer to the bone.
- •- Two or more skeletal metastases (= 2 hot spots) on bone scintigraphy within 8 weeks of randomization
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •- History of visceral metastasis, or visceral metastases
- •- Lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
- •- Central nervous system (CNS) metastases
- •- Treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to
- •randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the
- •treatment period or follow-up
- •- Chronic conditions associated with non-malignant abnormal bone growth (e.g. confirmed Paget's disease of bone)
- •- Prior treatment with radium-223 dichloride
- •- Prior systemic radiotherapy and hemibody external radiotherapy
研究者
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