Effect of Darbepoetin Alfa (Aranesp®) on Anemia in Patients With Advanced Hormone Independent Prostate Cancer

• Status: Terminated
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine whether or not Aranesp® (Darbepoetin Alfa), administered every fourth week, is effective in the treatment of blood shortage (anemia) compared to standard care of treatment (blood transfusions) in patients with anemia due to hormone refractory prostate cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborator: Amgen
• Treatments: Darbepoetin alfa; Hormones

Criteria

Inclusion Criteria:

• Male > 18 years

• 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)

• Haemoglobin level tested no later than 14 days prior to randomization

• A life expectancy of more than 3 months

• Participants must sign Informed consent according to local and national regulations and European Clinical Trial Directive

Exclusion Criteria:

• Known primary haematological disorder, which could cause anaemia

• Hypertension (diastolic blood pressure > 100 mmHg), refractory to treatment

• Symptomatic cardiovascular disease

• History of thromboembolic events during the last 12 months

• Concomitant Chemotherapy

• Active and severe liver disease

• 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

• Received erythropoietic therapy within 4 weeks before inclusion into the study

• Known positive antibody reaction to any erythropoietic agent