EUCTR2013-004055-20-GB进行中（未招募）1 期
A phase II randomised trial of biomarkers to assess (dose-) response in patients with metastatic castration resistant prostate cancer treated with radium-223. - REASURE (Radium-223: Evaluation of Activity and SUrrogate REsponse)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 38
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 castration resistant disease defined as:
- •- Castrate serum testosterone level: = 50 ng/dL (2.0nM) and;
- •- Bilateral orchidectomy or on maintenance androgen ablation therapy with LHRH agonist or polyestradiol phosphate throughout the study and;
- •- 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 =18 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:
- •a.Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L
- •b.Platelet count greater than or equal to 100 x109/L
- •c.Haemoglobin greater than or equal to 10.0 g/dL (100 g/L; 6.2 mmol/L)
- •d.Total bilirubin level less than or equal to 1.5 institutional upper limit of normal (ULN)
- •e.ASAT and ALAT less than or equal to 2.5 x ULN
- •f.Creatinine less than or equal to 1.5 x ULN
- •g.Albumin greater than 30 g/L
- •11) Willing and able to comply with the protocol, including all assessments, scans, procedures, follow-up visits and examinations.
- •12) Must be fully informed about the study and has signed the informed consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •1) Any prior radioisotope therapy.
- •2) Surgery, radiation, chemotherapy, or other anti-cancer 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.
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