A Phase II Randomised, Placebo-controlled, Multicentre Study in Prostate Cancer Patients With Painful Bone Metastases to Evaluate the Efficacy of Repeated Radium-223 Injections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 64
- 主要终点
- Time to occurrence of Skeletal-related Events (SRE)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223 in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.
详细描述
Primary objective:
To study the biological effectiveness of radium-223 therapy measured as:
- Time to occurrence of skeletal-related events(SREs)
- Change in bone-specific alkaline phosphatase (bone-ALP) levels
Secondary objectives:
To study the efficacy of radium-223 therapy in terms of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically confirmed adenocarcinoma of the prostate
- •Patient has received or is receiving hormonal treatment (orchiectomy, polyoestradiol phosphate, or gonadotropin-releasing hormone analogue with or without antiandrogen)
- •Metastatic disease with positive bone scan within 2 months before treatment with more than one cancer related lesion or with one painful cancer related lesion in the presence of increasing PSA levels as follows: PSA >5 ng/ml, with increases on at least 2 successive occasions at least 2 weeks apart.
- •Patient is referred to local field radiotherapy (EBR) for metastatic bone pain. The area to be treated (index site) should match the positive bone scan, local radiation area not exceeding 400 cm2
- •ECOG performance status: 0-2
- •Life expectancy: at least 3 months
- •Age more than 40 years
- •Laboratory requirements:
- •Hematology: Neutrophil count ≥1,5 x 109/L Platelet count at least ≥100 x109/L and stable Hemoglobin >100 g/l or 10 g/dL
- •Hepatic function: Bilirubin within normal institutional limits ASAT and ALAT <2,5 times upper limit of normal (ULN)
- •Renal function: Creatinine <1,5 times the ULN (i.e. NCI grade ≤1)
- •Patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examinations
- •Patient has been fully informed about the study and has signed the informed consent form
排除标准
- •Has received an investigational drug in the 4 weeks before or is scheduled to receiving one during the planned treatment period
- •Has received chemo-, immunotherapy or external radiotherapy within weeks before study drug administration
- •Has started treatment with bisphosphonates within 3 months before administration of study drug.
- •Has previously received systemic radiotherapy with strontium, samarium or rhenium
- •Change in hormonal therapy within the last 6 weeks before study drug administration
- •Other currently active (relapse within the last 3 year) malignancy (except nonmelanoma skin cancer) or known brain, liver, lung, visceral and lymphatic metastases dominating the clinical picture of the patient
- •Has received blood transfusion within last month
- •Other serious illness or medical condition as follows:
- •any uncontrolled infection
- •heart insufficiency, grade 3 or 4 as specified in NCI-CTC criteria
- •grade 2 or greater motor or sensory neuropathy
- •Crohn's disease or Ulcerative colitis 9) Known non-pathological bone fracture within the last two months
研究组 & 干预措施
Radium-223 dichloride (Xofigo, BAY88-8223)
Each subject receives local filed external beam radiotherapy (EBR) and repeated injections of the investigational drug radium-223 (EBR+Radium-223)
干预措施: Radium-223 dichloride (BAY88-8223) (Drug)
Saline
Each subject receives local filed external beam radiotherapy (EBR) and repeated injections of saline (EBR+placebo)
干预措施: Saline (Drug)
结局指标
主要结局
Time to occurrence of Skeletal-related Events (SRE)
时间窗: Up to 12 Month
SREs are defined as: Increase in pain severity index during the last week; Increase in analgesic consumption; Neurological symptoms secondary to skeletal manifestations of prostate cancer; New pathologic bone fractures (vertebral and non-vertebral); Tumour related orthopaedic surgical intervention; Subsequent external beam radiation to relieve skeletal pain; Use of radioisotopes to relieve new skeletal related symptoms; Use of corticosteroids for skeletal pain, at doses aimed for pain palliation; Use of chemotherapy, bisphosphonates, or hormones, for the treatment of skeletal disease progression
Relative change (%) in bone-ALP levels from baseline to 4 weeks after last injection
时间窗: Up to 12 Month
次要结局
- Number of SREs per patient(Up to 12 Month)
- Changes in the levels of biochemical markers of bone formation(Up to 12 Month)
- Change in Prostate Specific Antigen (PSA)(Up to 12 Month)
- Change in pain level(Up to 12 Month)
- Changes in analgesic use during study period(Up to 12 Month)
- Changes in Edmonton Symptom Assessment Scale (ESAS) from baseline(Up to 12 Month)
- Overall survival(up to 24 months)
- Adverse events(up to 24 months)
- Clinical laboratory tests including haematology, renal and liver function parameters(up to 24 months)