Clinical trial · Interventional
Effect of Darbepoetin Alfa (Aranesp®) on Anemia in Patients With Advanced Hormone Independent Prostate Cancer
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
NCT00381836CI-TRIAL-00020075terminatedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated by sponsor due to general risk that aranesp caused tumor progression
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darbepoetin Alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The haematopoietic response at week 4, 8, 12, 16 and 20
Secondary outcomes (4)
- measure
- Quality of Life (EQ-5D and QLQ-C30) at week 8 and 20
- measure
- Number of blood transfusions at week 4, 8, 12, 16 and 20
- measure
- Change in haemoglobin at week 4, 8, 12, 16 and 20
- measure
- Number of days admitted to hospital during the 20 week study period
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (22)
- BACKGROUNDAus G, Hugosson J, Norlen L. Long-term survival and mortality in prostate cancer treated with noncurative intent. J Urol. 1995 Aug;154(2 Pt 1):460-5. doi: 10.1097/00005392-199508000-00033. PMID 7541864
- BACKGROUNDPotosky AL, Miller BA, Albertsen PC, Kramer BS. The role of increasing detection in the rising incidence of prostate cancer. JAMA. 1995 Feb 15;273(7):548-52. PMID 7530782
- BACKGROUNDBorre M, Nerstrom B, Overgaard J. The dilemma of prostate cancer--a growing human and economic burden irrespective of treatment strategies. Acta Oncol. 1997;36(7):681-7. doi: 10.3109/02841869709001337. PMID 9490083
- BACKGROUNDBrasso K, Friis S, Kjaer SK, Iversen P. [Prostatic cancer men under age 65. Occurrence and need for study]. Ugeskr Laeger. 1997 Apr 21;159(17):2543-5. Danish. PMID 9182383
- BACKGROUNDBorre M, Nerstrom B, Overgaard J. The natural history of prostate carcinoma based on a Danish population treated with no intent to cure. Cancer. 1997 Sep 1;80(5):917-28. PMID 9307192
- BACKGROUNDAus G, Hugosson J, Norlen L. Need for hospital care and palliative treatment for prostate cancer treated with noncurative intent. J Urol. 1995 Aug;154(2 Pt 1):466-9. doi: 10.1097/00005392-199508000-00034. PMID 7541865
- BACKGROUNDOtnes B, Harvei S, Fossa SD. The burden of prostate cancer from diagnosis until death. Br J Urol. 1995 Nov;76(5):587-94. doi: 10.1111/j.1464-410x.1995.tb07783.x. PMID 8535677
- BACKGROUNDCarlsson P, Hjertberg H, Jonsson B, Varenhorst E. The cost of prostatic cancer in a defined population. Scand J Urol Nephrol. 1989;23(2):93-6. doi: 10.3109/00365598909180819.