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

December 3, 2015 updated by: University of Aarhus

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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-skin cancer in Danish men and the second most common cause of male cancer death. Two out of three patients with clinically significant prostate cancer die from and not with their cancer disease, and the misery of this population is evident. Regular treatments with opiates or equivalent drugs as well are required in nearly one third of the patients.

Patients with advanced hormone insensitive (refractory) prostate cancer have a median survival rate of about one year and during this time they often suffer from anemia due to reasons like blood loss, tumor infiltration of the bone marrow and even treatment with androgen deprivation. Compared to patients with other cancer types patients with prostate cancer have a significantly lower mean haemoglobin level. However, patients with hormone refractory prostate cancer have not previously been given much attention and the treatment of the frequent condition of chronic anemia in this group of patients seems casual. Therefore, Best Standard of Care (BSC) is defined as RBC transfusion if the hemoglobin is < 5,0 mmol/L (8,0 g/dl), and if there are signs or symptoms of anemia and supplemental iron if se-ferritin < 200 mcg/L.

Very little is known about erythropoietin treatment and quality of life in hormone refractory prostate cancer patients. A randomized Swedish study did investigate the influence of two different doses of epoetin beta on quality of life, hemoglobin level, need for red blood cell transfusion and safety, in the treatment of anemia in 180 patients suffering from advanced hormone-refractory prostate cancer. This study found the treatment to be safe and effective for the treatment in many of these patients. In many of these critically ill patients, the treatment improved quality of life and relieved fatigue symptoms.

Darbepoetin alpha (Aranesp®) is produced by gene-technology in Chinese Hamster Cells (CHO-K1). It has a biological effect and toxicity profile comparable to r-HuEPO; with the exception of a longer half-life which means that it can be administered less frequently without loosing clinical efficiency. Aranesp® has been well tolerated in studies conducted to this date. In this setting Aranesp® appears to be safe and well tolerated. Adverse events reported to date have generally been mild to moderate in severity and consistent with events and symptoms in cancer patients with chronic disease receiving chemotherapy (i.e. fatigue and gastrointestinal symptoms). Clinical studies have shown a higher frequency of thromboembolic reactions including deep vein thrombosis and pulmonary embolism in cancer patients receiving Aranesp therapy compared to patients receiving placebo. The clinical experience so far with Aranesp® has been published (15,16,17). Aranesp® is registered for clinical use in Europe and US.

Based on this the present study will evaluate the effect of Aranesp® on the haematopoietic response in patients with advanced hormone independent prostate cancer and anemia. Moreover, the effect of Aranesp® on quality of life, hemoglobin, necessity for RBC transfusion and hospital admissions, will be evaluated. The study will be performed as an open randomized trial. The use of r-HuEPO in cancer patients has been established and registered in other settings (as supportive treatment), and it has been shown that the preparation can be given without significant side effects. On the contrary, it is likely that patients may benefit from additional improvement in wellbeing.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Urology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Amgen

Investigators

  • Principal Investigator: Michael Borre, MD, PhD, Department of Urology, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

September 27, 2006

First Submitted That Met QC Criteria

September 27, 2006

First Posted (Estimate)

September 28, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-005658-37
  • LM: 2612-3148
  • Ethical: 20060074
  • Data Protection: 2005-41-6015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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