EUCTR2007-006195-11-NL进行中（未招募）不适用
A double-blind, randomised, multiple dose, Phase III, multicentre study of Alpharadin in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases. - Not Applicable
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Algeta ASA
- 入组人数
- 900
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
- •1. Histologically or cytologically confirmed adenocarcinoma of the prostate
- •2. Known hormone refractory disease defined as:
- •Castrate serum testosterone level: = 50 ng/dL (1.7 nmol/L)
- •Bilateral orchiectomy or maintenance on androgen ablation therapy with LHRH agonist or polyestradiol phosphate throughout the study
- •Serum PSA progression defined as two consecutive increases in PSA over a previous reference value,
- •each measurement at least 1 week apart)
- •3. Serum PSA value = 5 ng/mL (µg/L)
- •4. Multiple skeletal metastases (= 2 hot spots) on bone scintigraphy within previous 12 weeks
- •5. No intention to use cytotoxic chemotherapy within the next 6 months
- •6. Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT for bone pain within previous 12 weeks
- •7. Age = 18 years
- •8. ECOG Performance status (PS): 0-2
- •9. Life expectancy = 6 months
- •10. Laboratory requirements:
- •a. Absolute neutrophil count (ANC) = 1.5 x 10^9/L
- •b. Platelet count = 100 x10^9/L
- •c. Hemoglobin = 10.0 g/dL (100 g/L; 6.2 mmol/L)
- •d. Total bilirubin level = 1.5 institutional upper limit of normal (ULN)
- •e. ASAT and ALAT = 2.5 ULN
- •f. Creatinine = 1.5 ULN
- •g. Albumin >25 g/L
- •11. Willing and able to comply with the protocol, including follow-up visits and examinations
- •12. Must be fully informed about the study and signed the informed consent form
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period
- •2. Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available
- •3. Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago
- •4. Prior hemibody external radiotherapy
- •5. Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
- •6. Prior treatment with radium-223
- •7. Blood transfusion or erythropoetin stimulating agents within previous 4 weeks
- •8. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
- •9. History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks
- •10. Malignant lymphadenopathy exceeding 3 cm in short-axis diameter
- •11. Imminent or established spinal cord compression based on clinical findings and/or MRI
- •12. Any other serious illness or medical condition such as, but not limited to:
- •any uncontrolled infection
- •cardiac failure NYHA III or IV
- •Crohns' disease or Ulcerative colitis
- •Bone marrow dysplasia
- •13. Unmanageable faecal incontinence
研究者
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