Status:
TERMINATED
Effect of Darbepoetin Alfa (Aranesp®) on Anemia in Patients With Advanced Hormone Independent Prostate Cancer
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Amgen
Conditions:
Prostatic Neoplasms
Anemia
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
In the past, prostate cancer has been regarded a relatively benign disease, which elderly men were expected to die with rather than from, however, prostate cancer has become the second most common non...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00381836
Start Date
October 1 2006
End Date
February 1 2007
Last Update
December 4 2015
Active Locations (1)
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1
Department of Urology, Aarhus University Hospital
Aarhus, Denmark, 8000