EUCTR2012-000075-16-CZ进行中（未招募）1 期
Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis - Radium-223 dichloride in the treatment of CRPC/HRPC patients with bone metastasis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
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
- •Eligible patients will conform to all of the inclusion criteria listed below:
- •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 imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed). A standard of practice bone scan for the documentation of at least 2 skeletal metastases can be used as long as it is within 3 months of planned start of treatment. If no bone scan within a 3 month window is available, then a technetium-99m bone scan will be obtained at screening (within 28 days of planned start of study drug).
- •Progressive disease is defined either by:
- •o The appearance of new bone lesions. If progression is based on new lesion(s) on bone imaging only without an increase in prostate specific antigen (PSA), PSA values from 3 assessments within the last 6 months must be provided; OR
- •o In the absence of new bone lesions by 2 subsequent 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. (The reference value time point 1, is defined as the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart. If the PSA at time point 3 is greater than the PSA at time point 2, then eligibility has been met. If the PSA at time point 3 is not greater than the PSA at time point 2 but the PSA value at time point 4 and/or time point 5 is, the patient is eligible assuming that other criteria are met)
- •No intention to use cytotoxic chemotherapy within the next 6 months
- •Life expectancy = 6 months
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (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 675
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 675
排除标准
- •Eligible patients must not meet any of the exclusion criteria listed below:
- •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, prior to screening, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks previous prior to screening (however, ongoing neuropathy is permitted)
- •Treatment with any prior anticancer theraphy (including, therapeutic vaccines), other than the permitted Standard of Care therapies (please refer to section 6.9), are allowed provided that they are completed 28 days before treatment or 5.5 half-lives of the drugs involved have elapsed before treatment start.
- •Prior hemibody external radiotherapy is excluded. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets.
- •Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) 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 based on institutional standard of care)
- •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 spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.
- •Any other serious illness or medical condition, such as but not limited to:
- •o Any infection = National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
- •o Cardiac Failure New York Heart Association (NYHA) Class III or IV
- •o Crohn’s disease or ulcerative colitis
- •o Bone marrow dysplasia
- •Fecal incontinence
研究者
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