A randomized, multi-center study to assess the effect of Darbepoetin alfa (Aranesp®) for the treatment of anemia in patients with advanced hormone independent prostate cancer and anaemia - DANCAPepo

Dpt. of Urology -K. Aarhus University Hospital0 个研究点目标入组 140 人开始时间: 2006年5月19日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•Histologically proven prostate cell carcinoma.
•Progression in PSA (10% elevation of nadir-value documented by two tests) at least 4 months after surgical orchiectomy or initiation of LHRH-agonist. Testosterone level must be below castration level.
•All PSA values must be > 5 ng/ml.
•Haemoglobin level below 11 g/dl (6.8 mmol/l).
•A life expectancy of more than 3 months.
•Informed consent according to local and national regulations.
•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

•No hypertension (diastolic blood pressure > 100 mmHg), refractory to treatment.
•No symptomatic cardiovascular disease or previous history of seizure and with history of thromboembolic events.
•clinical significant inflammatory disease.
•concomitant or previous malignancies, which are likely to influence the treatment, evaluation and outcome of the current disease and therapy.
•concern of subject’s compliance with the protocol procedures.
•previously included into the study.
•Informed consent according to local and national regulations.
•received any erythropoietic therapy within 4 weeks before inclusion into the study.
•known positive antibody reaction to any erythropoietic agent.

发起方

Dpt. of Urology -K. Aarhus University Hospital