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.
OBJECTIVES: * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Enrollment
282
Memorial Medical Center Cancer Services
Modesto, California, United States
Aurora Presbyterian Hospital
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale
Anemia response at 3 months
Functional level as measured by the Functional Assessment of Cancer Therapy-General Scale and Brief Fatigue Inventory functional interference score monthly
Symptom distress as measured by the Memorial Symptom Assessment Scale-Short Form and the number of symptoms monthly
Quality of life as measured by the Functional Assessment of Cancer Therapy-General Scale monthly
Survival at 6 months
Adrenal suppression
Toxicity
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States
St. Joseph Hospital
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
...and 130 more locations