NCT02135484已完成不适用
An Observation, Open Label Study of Alpharadin (Radium 223) in Patients With Castrate Resistant Prostate Cancer Bone Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Overall Survival (Favorable and Unfavorable )
研究概览
简要总结
The goal of this clinical research study is to learn more about how the study drug alpharadin (Radium-223) works in patients who have CPRC that has spread to the bone.
详细描述
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive radium-223 by vein over about 1 minute at the beginning of every study cycle for 6 cycles. Every 4 weeks is a study cycle.
You will need to be well hydrated before each dose by drinking at least 2-3 cups (8 ounces each) of water.
Do not take additional drugs, including over-the-counter products and herbal/alternative drugs, during the study without talking with the study doctor first.
Study Visits:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven adenocarcinoma of the prostate with evidence for skeletal metastases on bone scan and/or CT scan and symptoms judged to be related to bone metastases
- •Eastern Cooperative Oncology Group (ECOG) performance status <
- •(Karnofsky Performance Status >/= 50%)
- •Serum testosterone levels < 50ng/ml
- •Ongoing gonadal androgen deprivation therapy with Luteinizing Hormone-Releasing Hormone (LHRH) analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on standard dosing of LHRH analogue therapy at appropriate frequency for the duration of the study
- •Life expectancy of at least 12 weeks (3 months)
- •Discontinue any steroids prescribed to specifically treat prostate cancer (for e.g as a secondary hormonal manipulation or for cord compression) > 4 weeks prior to study drug. Steroids chronically prescribed for a non-cancer-related illness [e.g. asthma or chronic obstructive pulmonary disease (COPD)] that is well controlled with medical management are permissible to an equivalent of <10 mg Prednisone daily. Note: Steroids may be administered during the study as supportive care
- •Laboratory Requirements: a.) white blood cell (WBC) count > 3,000/ul; b.) Absolute Neutrophil Count (ANC) > 1,500/ul; c.) Hemoglobin >/= 8.0 g/dL independent of transfusion; d.) Platelet count >/= 100,000/uL; e.) Serum albumin >/= 3.0 g/dL; f.) Calculated or measured creatinine clearance > 30 mL/min
- •All acute toxic effects of any prior treatment have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF)
- •Patient must be willing and able to comply with protocol requirements. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study
- •Patients must also have signed an authorization for the release of their protected health information
排除标准
- •Treatment with cytotoxic chemotherapy within previous 4 weeks of protocol treatment, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks prior to protocol treatment (however, ongoing neuropathy is permitted)
- •Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Ra-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)
- •Known 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). Treatment should be completed for spinal cord compression
- •Any other serious illness or medical condition, such as but not limited to: a) Any infection >/= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 Grade 2; b) Cardiac failure New York Heart Association (NYHA) III or IV; c) Crohn's disease or ulcerative colitis; d) Bone marrow dysplasia; e) Fecal incontinence
- •Inability to comply with the protocol and/or not willing or not available for follow-up assessments
- •Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
- •Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than Ra 223 dichloride
- •Prior use of Ra-223 dichloride, Strontium or Samarium
- •Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
- •Major surgery within 30 days prior to start of study drug
研究组 & 干预措施
Alpharadin
Experimental
Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
干预措施: Alpharadin (Drug)
结局指标
主要结局
Overall Survival (Favorable and Unfavorable )
时间窗: 3.6 years
Overall survival is measured in months from the time of enrollment until death. Participants who survived longer then the median survival rate of 24.3 months were assigned favorable survival. Participants who survived less than 24.3 months were assigned unfavorable survival.
次要结局
未报告次要终点
研究者
研究点 (1)
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