In an open randomised, multi-center study to identify the haematopoietic response to Aranesp® (Darbepoetin 6,75 mcg/kg) administrated every fourth week compared to standard care of treatment in patients with anaemia due to hormone refractory prostate cancer with progression of skeletal metastases. A haematopoietic response is defined as haemoglobin concentration > 12 g/dl or increase in haemoglobin > 2 g/dl during the treatment phase. MedDRA version: 6.1 Level: PT Classification code 10038444
Conditions
Interventions
Trade Name: Aranesp
Product Name: Aranesp® Darbepoetin alfa
Pharmaceutical Form: Solution for injection
INN or Proposed INN: darbepoetin alfa
CAS Number: 209810-58-2
Sponsors
Dpt. of Urology -K. Aarhus University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In an open randomised, multi-center study to identify the haematopoietic response to Aranesp® (Darbepoetin 6,75 mcg/kg) administrated every fourth week compared to standard care of treatment in patients with anaemia due to hormone refractory prostate cancer with progression of skeletal metastases. A haematopoietic response is defined as haemoglobin concentration > 12 g/dl or increase in haemoglobin > 2 g/dl during the treatment phase.;Secondary Objective: •To study the effect of Aranesp® (Darbepoetin 6,75 mcg/kg) administrated Q4W compared to standard care of treatment on the Quality of Life in patients with anaemia due to hormone refractory prostate cancer. •To evaluate the necessity for blood transfusion. •To study the effect of Aranesp ® 500 mcg administrated Q4W compared to standard care of treatment on the change in haemoglobin. •To study the haematopoietic response after 8 and 20 weeks of Aranesp® 500 mcg treatment in the subgroup of patients defined as non-responders by an increase in haemoglobin less than 1 g/dl (0,6 mmol/l) at week 8. To register the number of days admitted to hospital during the study period due to treatment of anaemia caused by prostate cancer disease. ;Primary end point(s): Haemoglobin level at 0, 4, 8, 12, 16 and 20 weeks after start of Aranesp®. Quality of life assesments at 0, 10 and 20 weeks after start of Aranesp®. | — |
Countries
Denmark
Outcome results
None listed