Prostatic NeoplasmsPhase 2/3NCT00381836
Effect of Darbepoetin Alfa (Aranesp®) on Anemia in Patients With Advanced Hormone Independent Prostate Cancer
A Phase 2/3 study testing Darbepoetin Alfa in people with Prostatic Neoplasms and Anemia, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Anemia
- What is being tested?
- Darbepoetin Alfa
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2006to Feb 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostatic Neoplasms, Anemia
- Being tested
- Darbepoetin Alfa
- 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
- Medical subject headings
- Prostatic Neoplasms, Anemia, Neoplasms, Critical Illness, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin AlfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: Terminated by sponsor due to general risk that aranesp caused tumor progression
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Michael Borre, MD, PhD, Principal investigator, Department of Urology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381836
- Sponsor's protocol ID
- 2005-005658-37
- Other IDs
- LM: 2612-3148, Ethical: 20060074, Data Protection: 2005-41-6015, 2005
- Status last verified
- Feb 2008
- First submitted
- 27 Sep 2006
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Aus 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.
PubMed 7541864Potosky 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.
PubMed 7530782Borre 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.
PubMed 9490083Brasso 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.
PubMed 9182383Borre 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.
PubMed 9307192Aus 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.
PubMed 7541865Otnes 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.
PubMed 8535677Carlsson 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.
PubMed 2787931Brasso K, Friis S, Juel K, Jorgensen T, Iversen P. The need for hospital care of patients with clinically localized prostate cancer managed by noncurative intent: a population based registry study. J Urol. 2000 Apr;163(4):1150-4.
PubMed 10737485Strum SB, McDermed JE, Scholz MC, Johnson H, Tisman G. Anaemia associated with androgen deprivation in patients with prostate cancer receiving combined hormone blockade. Br J Urol. 1997 Jun;79(6):933-41. doi: 10.1046/j.1464-410x.1997.00234.x.
PubMed 9202563Ornstein DK, Beiser JA, Andriole GL. Anaemia in men receiving combined finasteride and flutamide therapy for advanced prostate cancer. BJU Int. 1999 Jan;83(1):43-6. doi: 10.1046/j.1464-410x.1999.00844.x.
PubMed 10233450Johansson 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.
PubMed 11676354Dunn A, Carter J, Carter H. Anemia at the end of life: prevalence, significance, and causes in patients receiving palliative care. J Pain Symptom Manage. 2003 Dec;26(6):1132-9. doi: 10.1016/j.jpainsymman.2003.04.001.
PubMed 14654265Egrie 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.
PubMed 11308268Heatherington AC, Schuller J, Mercer AJ. Pharmacokinetics of novel erythropoiesis stimulating protein (NESP) in cancer patients: preliminary report. Br J Cancer. 2001 Apr;84 Suppl 1(Suppl 1):11-6. doi: 10.1054/bjoc.2001.1747.
PubMed 11308269
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00381836
- Acronym / sponsor ID
- 2005-005658-37
- Conditions
- Prostatic Neoplasms, Anemia
- Keywords
- Prostate Cancer, Anemia, Blood transfusion, Cancer, Critical illness, Drug efficacy, Drug safety, Drug tolerability
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by sponsor due to general risk that aranesp caused tumor progression
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Oct 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darbepoetin Alfa | Drug | – |
Primary outcome
The haematopoietic response at week 4, 8, 12, 16 and 20
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Terminated by sponsor due to general risk that aranesp caused tumor progression). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
- Background: PubMed 7541864Aus 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.
- Background: PubMed 7530782Potosky 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.
- Background: PubMed 9490083Borre 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.
- Background: PubMed 9182383Brasso 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.
- Background: PubMed 9307192Borre 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.
- Background: PubMed 7541865Aus 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.
- Background: PubMed 8535677Otnes 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.
- Background: PubMed 2787931Carlsson 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.
- Background: PubMed 10737485Brasso K, Friis S, Juel K, Jorgensen T, Iversen P. The need for hospital care of patients with clinically localized prostate cancer managed by noncurative intent: a population based registry study. J Urol. 2000 Apr;163(4):1150-4.
- Background: PubMed 9202563Strum SB, McDermed JE, Scholz MC, Johnson H, Tisman G. Anaemia associated with androgen deprivation in patients with prostate cancer receiving combined hormone blockade. Br J Urol. 1997 Jun;79(6):933-41. doi: 10.1046/j.1464-410x.1997.00234.x.
- Background: PubMed 10233450Ornstein DK, Beiser JA, Andriole GL. Anaemia in men receiving combined finasteride and flutamide therapy for advanced prostate cancer. BJU Int. 1999 Jan;83(1):43-6. doi: 10.1046/j.1464-410x.1999.00844.x.
- Background: PubMed 11676354Johansson 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Borre, MD, PhD principal investigator
Department of Urology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Darbepoetin Alfa in people with Prostatic Neoplasms and Anemia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated by sponsor due to general risk that aranesp caused tumor progression). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The haematopoietic response at week 4, 8, 12, 16 and 20. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00381836, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.