EUCTR2007-006195-11-IT进行中（未招募）不适用
A double blind, randomised, multiple dose, phase III, multicentre study of AlpharadinTM in the treatment of patients with hormone-refractory prostate cancer with skeletal metastases - ND
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
- 750
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 �� Bilateral orchiectomy or maintenance on androgen ablation therapy with LHRH agonist or polyestradiol phosphate throughout the study 3. Serum PSA progression defined as two consecutive increases in PSA over a previous reference value, each measurement at least 1 week apart) 4. Serum PSA value >= 5 ng/mL (μg/L) 5. Multiple skeletal metastases (>= 2 hot spots) on bone scintigraphy within previous 12 weeks 6. No intention to use cytotoxic chemotherapy within the next 6 months 7. Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT for bone pain within previous 12 weeks 8. Age >=18 years 9. ECOG Performance status (PS): 0-2 10. Life expectancy >= 6 months 11. Laboratory requirements: a. Absolute neutrophil count (ANC) >= 1.5 x 109/L b. Platelet count >=100 x109/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 12. Willing and able to comply with the protocol, including follow-up visits and examinations 13. 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. 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 3. Prior hemibody external radiotherapy 4. Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks 5. Prior treatment with radium-223 6. Blood transfusion or erythropoetin stimulating agents within previous 4 weeks 7. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer) 8. History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks 9. Malignant lymphadenopathy exceeding 3 cm in short-axis diameter 10. Imminent or established spinal cord compression based on clinical findings and/or MRI 11. 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 12. Unmanageable faecal incontinence
研究者
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