ISRCTN17805587已完成2 期
A phase II randomised trial of biomarkers to assess (dose) response in patients with metastatic castration resistant prostate cancer treated with radium-223
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
2021 Results article in https://doi.org/10.1016/j.clgc.2021.03.020 Fracture risk (added 07/05/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37788117/ Disease response in bone (added 04/10/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Histologically or cytologically confirmed adenocarcinoma of the prostate.
- •2. Known castration resistant disease defined as:
- •2.1. Castrate serum testosterone level: = 50 ng/dL (2.0nM)
- •2.2. Bilateral orchidectomy or on maintenance androgen ablation therapy with LHRH agonist or polyestradiol phosphate throughout the study
- •2.3. Serum PSA progression defined by PCWG II criteria (i.e. two consecutive increases in PSA over a previous reference value, each measurement taken at least 1 week apart)
- •3. Serum PSA value = 2 ng/mL
- •4. Available ALP result from a blood sample taken within previous 8 weeks
- •5. Multiple skeletal metastases (= 2 hot spots) on bone scintigraphy within previous 12 weeks
- •6. Age =16 years
- •7. ECOG performance status 0-2.
- •8. Life expectancy = 6 months.
- •9. No prior chemotherapy for CRPC (adjuvant chemotherapy for hormone naïve disease is permissible).
- •10. Adequate laboratory requirements:
- •10.1.Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L
- •10.2. Platelet count greater than or equal to 100 x109/L
- •10.3. Haemoglobin greater than or equal to 10.0 g/dL (100 g/L; 6.2 mmol/L)
- •10.4. Total bilirubin level less than or equal to 1.5 institutional upper limit of normal (ULN)
- •10.5. ASAT and ALAT less than or equal to 2.5 x ULN
- •10.6. Creatinine less than or equal to 1.5 x ULN
- •10.7. Albumin greater than 30 g/L
- •11. Willing and able to comply with the protocol, including all assessments, scans, procedures, followup visits and examinations
- •12. Must be fully informed about the study and has signed the informed consent form
排除标准
- •1. Any prior radioisotope therapy
- •2. Surgery, radiation, chemotherapy, or other anticancer therapy within four weeks prior to randomisation into the study with the exception of LHRH agonists
- •3. Intention to commence cytotoxic chemotherapy within six months
- •4. Prior other malignancy within three years. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed
- •5. Treatment with any investigational drug within 30 days prior to randomisation into the study
- •6. History of visceral metastasis, or visceral metastases, as assessed by chest/abdominal/pelvic CT within previous 8 weeks
- •7. Malignant lymphadenopathy exceeding 1.5 cm in short-axis diameter
- •8. Known brain or leptomeningeal involvement
- •9. Imminent/established spinal cord compression based on clinical findings/MRI (can be re-screened following appropriate treatment)
- •10. Blood transfusion or erythropoietin stimulating agents within the four weeks prior to randomisation
- •11. Faecal incontinence
- •12. Unsuitable for MRI (patient refusal or clinical contra-indication)
- •13. Inadequate organ or bone marrow function
- •14. Any other serious illness or medical condition
研究者
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