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

NCT00381836 | Terminated Phase 2

• 4 other identifiers: 2005-005658-37LM: 2612-3148Ethical: 20060074Data Protection: 2005-41-6015
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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 of treatment (blood transfusions) in patients with anemia due to hormone refractory prostate cancer.

Conditions

Prostatic Neoplasms; Anemia

Keywords

Prostate Cancer; Anemia; Blood transfusion; Cancer; Critical illness; Drug efficacy; Drug safety; Drug tolerability; Erythropoietin; Fatigue; Hemoglobin; Human; Male; Multicenter study; Quality of life; Questionnaire; Randomized controlled trial; Recombinant erythropoietin

Outcome Measures

Primary Outcomes (1)

• The haematopoietic response at week 4, 8, 12, 16 and 20

Secondary Outcomes (4)

• Quality of Life (EQ-5D and QLQ-C30) at week 8 and 20

• Number of blood transfusions at week 4, 8, 12, 16 and 20

• Change in haemoglobin at week 4, 8, 12, 16 and 20

• Number of days admitted to hospital during the 20 week study period

Interventions

Darbepoetin Alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Known positive antibody reaction to any erythropoietic agent

Sponsors & Collaborators

• University of Aarhus: lead
• Amgen: collaborator

Study Sites (1)

Department of Urology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (22)

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• Johansson JE, Wersall P, Brandberg Y, Andersson SO, Nordstrom L; EPO-Study Group. Efficacy of epoetin beta on hemoglobin, quality of life, and transfusion needs in patients with anemia due to hormone-refractory prostate cancer--a randomized study. Scand J Urol Nephrol. 2001 Sep;35(4):288-94. doi: 10.1080/003655901750425864.

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• Egrie JC, Browne JK. Development and characterization of novel erythropoiesis stimulating protein (NESP). Br J Cancer. 2001 Apr;84 Suppl 1(Suppl 1):3-10. doi: 10.1054/bjoc.2001.1746.

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• Smith RE Jr, Tchekmedyian NS, Chan D, Meza LA, Northfelt DW, Patel R, Austin M, Colowick AB, Rossi G, Glaspy J. A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer. Br J Cancer. 2003 Jun 16;88(12):1851-8. doi: 10.1038/sj.bjc.6600994.

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• Bohlius J, Wilson J, Seidenfeld J, Piper M, Schwarzer G, Sandercock J, Trelle S, Weingart O, Bayliss S, Djulbegovic B, Bennett CL, Langensiepen S, Hyde C, Engert A. Recombinant human erythropoietins and cancer patients: updated meta-analysis of 57 studies including 9353 patients. J Natl Cancer Inst. 2006 May 17;98(10):708-14. doi: 10.1093/jnci/djj189.

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MeSH Terms

Conditions

Prostatic Neoplasms; Anemia; Neoplasms; Critical Illness; Fatigue

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Michael Borre, MD, PhD

  Department of Urology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 28, 2006
• Study Start: October 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: December 4, 2015

Record last verified: 2008-02

Locations

DK (1)