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Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00060398
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : May 12, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Epoetin alfa may stimulate red blood cell production and may help improve cancer-related anemia and fatigue. Steroid therapy with dexamethasone may increase the effectiveness of epoetin alfa. It is not yet known if epoetin alfa is more effective with or without dexamethasone in treating anemia-related fatigue in patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying epoetin alfa and dexamethasone to see how well they work compared to epoetin alfa alone in treating anemia-related fatigue in patients with prostate cancer that is refractory to treatment with hormone therapy.

Condition or disease Intervention/treatment Phase
Anemia Fatigue Prostate Cancer Biological: epoetin alfa Drug: dexamethasone Phase 3

Detailed Description:


  • Compare the effect of epoetin alfa with or without dexamethasone on the level of cancer-related fatigue measured by the FACIT fatigue subscale, in patients with hormone-refractory prostate cancer.
  • Compare the effect of these regimens on increasing hemoglobin levels in these patients.
  • Compare the effect of these regimens on palliation of other disease-related symptoms and on functional status and overall quality of life of these patients.
  • Compare the survival rate of these regimens in these patients.
  • Compare the toxicity profile of these regimens in these patients.
  • Determine the incidence of adrenal suppression in these patients after receiving dexamethasone therapy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to usual fatigue severity on the Brief Fatigue Inventory numerical scale (3-6 vs 7-10) and hemoglobin level (8-10 g/dL vs 10.1-11.9 g/dL). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive epoetin alfa subcutaneously once a week.
  • Arm II: Patients receive epoetin alfa as in arm I and oral dexamethasone once a day.

In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity.

Quality of life and fatigue are assessed at baseline and then at 4, 8, and 12 weeks.

Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 282 patients (141 per treatment arm) will be accrued for this study within approximately 3 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Study Of Epoetin Alfa Vs Epoetin Alfa With Dexamethasone In Hormone Refractory Prostate Cancer Patients: Impact On Fatigue, Anemia, Functional Status And Quality Of Life
Study Start Date : June 2004
Actual Primary Completion Date : June 2006

Primary Outcome Measures :
  1. Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale

Secondary Outcome Measures :
  1. Anemia response at 3 months
  2. Functional level as measured by the Functional Assessment of Cancer Therapy-General Scale and Brief Fatigue Inventory functional interference score monthly
  3. Symptom distress as measured by the Memorial Symptom Assessment Scale-Short Form and the number of symptoms monthly
  4. Quality of life as measured by the Functional Assessment of Cancer Therapy-General Scale monthly
  5. Survival at 6 months
  6. Adrenal suppression
  7. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed prostate cancer

    • Hormone-refractory disease as evidenced by progression on bone scan or CT scan with a rising prostate-specific antigen
  • Prior bilateral orchiectomy OR other primary hormonal therapy (e.g., estrogen therapy or luteinizing hormone-releasing hormone analog [LHRH] and flutamide) with evidence of treatment failure

    • Concurrent continual LHRH agonist therapy (e.g., depot leuprolide or goserelin) required for patients who have not undergone bilateral orchiectomy
  • Must have anemia with hemoglobin ≥ 8 g/dL and < 12 g/dL within the past 14 days
  • Must be iron replete (i.e., ferritin > 50 ng/mL) within the past 30 days
  • Presence of fatigue with usual fatigue severity ≥ 3 on the 0-10 numerical scale of the Brief Fatigue Inventory within the past 14 days



  • 18 and over

Performance status

  • ECOG 0-3

Life expectancy

  • Not specified


  • See Disease Characteristics
  • No disseminated intravascular coagulation
  • No autoimmune hemolytic anemia


  • AST and ALT ≤ 2 times upper limit of normal
  • No prior hemochromatosis or iron intolerance


  • Creatinine < 2.5 mg/dL


  • Adequate blood pressure (i.e., systolic blood pressure < 140 mm Hg and diastolic blood pressure < 90 mm Hg) (treated or untreated)
  • No history of thromboembolic events
  • No unstable angina
  • No poorly controlled cardiac disease


  • Fertile patients must use effective contraception
  • Able to read, understand, and answer questions on the symptom and quality of life study instruments
  • No ongoing chronic hemorrhage (e.g., gross hematuria due to advanced prostate cancer)* NOTE: *Microscopic hematuria allowed
  • No acute or subacute illness that may require transfusion
  • No gastrointestinal bleeding
  • No active systemic infection
  • No known or suspected hypersensitivity to human albumin
  • No known or suspected hypersensitivity to mammalian cell-derived products
  • No uncontrolled diabetes


Biologic therapy

  • More than 30 days since prior epoetin alfa


  • More than 21 days since prior chemotherapy
  • No more than 2 different types of prior chemotherapy regimens for hormone-refractory prostate cancer

Endocrine therapy

  • See Disease Characteristics
  • More than 30 days since prior corticosteroids for hormone-refractory prostate cancer

    • Episodic use of low-dose steroids for other causes is allowed


  • More than 21 days since prior radiotherapy
  • Concurrent radiotherapy allowed


  • See Disease Characteristics


  • More than 8 weeks since prior blood transfusion
  • No concurrent oral or intravenous antibiotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00060398

Show Show 140 study locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: Shirley S. Hwang, RN, MS Veterans Affairs Medical Center - East Orange
Layout table for additonal information Identifier: NCT00060398    
Other Study ID Numbers: CDR0000301881
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: May 12, 2009
Last Verified: July 2006
Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hematologic Diseases
Signs and Symptoms
Epoetin Alfa
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents