EUCTR2012-000075-16-ES进行中（未招募）1 期
Radium-223 Chloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,925
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
- •- Has provided written informed consent. Subjects must be able to understand and be willing to sign the written informed consent form (ICF). A signed ICF must be appropriately obtained prior to the conduct of the any trial- specific procedure.
- •? Age ? 18 years
- •? Histologically or cytologically confirmed prostate cancer
- •? Patients diagnosed with progressive bone predominant metastatic CRPC/HRPC with at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
- •? Progressive disease is defined either by:
- •o The appearance of new bone lesions. If progression is based on new lesion(s) on bone scan only without an increase in PSA, PSA values from 3 assessments within the last 6 months must be provided; OR
- •o In the absence of a new bone lesions by 2 consecutive increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ?5 ng/mL
- •? Life expectancy ? 6 months
- •? ECOG PS 0-2
- •? Adequate hematological, liver and renal function
- •o Absolute neutrophil count (ANC) ? 1.5 x109/L
- •o Platelet count ? 100 x109/L
- •o Hemoglobin ?10.0 g/dL (100 g/L; 6.2 mmol/L)
- •o Total bilirubin level ? 1.5 x institutional upper limit of normal (ULN)
- •o Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 x ULN
- •o Creatinine ? 1.5 x ULN
- •o Albumin > 25 g/L
- •? Willing and able to comply with the protocol, including follow-up visits and examinations
- •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 925
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1000
排除标准
- •? Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
- •? Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
- •? Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted)
- •? Received previous radiotherapy to approximately > 25% of bone marrow, including hemibody radiation
- •? Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 chloride) for the treatment of bony metastases
- •? Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
- •? Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) or other imaging modality
- •? Presence of brain metastases
- •? Lymphadenopathy exceeding 6 cm in short-axis diameter
- •? Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis.
- •? Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
- •? Any other serious illness or medical condition, such as but not limited to:
- •o Any infection ? NCI-CTCAE v.4.03 Grade 2
- •o Cardiac failure New York Heart Association (NYHA) III or IV
- •o Crohn?s disease or ulcerative colitis
- •o Bone marrow dysplasia
- •? Fecal incontinence
研究者
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