Impact of Erythropoietin Treatment Versus Placebo on Quality-of-life in Patients With Advanced Prostate Cancer.
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The purpose of this study was to evaluate the effect of treatment with epoetin alfa (recombinant human erythropoietin) or placebo on anemia related quality-of-life and anemia in hormone-refractory (not responding to hormone therapy) prostate cancer patients.
The primary outcome was change in Quality of Life (FACT-An Anemia scale) from baseline to 16 weeks.
Secondary Outcome Measures :
QoL was measured at baseline, 4, 8, 12, 16 and 20 weeks (FACT-An Total and Cancer Linear Analogue Scale). Hb and Hematocrit levels were assessed at baseline, 4, 8, 12, 16 and 20 weeks. Transfusion requirements were recorded throughout the trial.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with histological confirmed adenocarcinoma of the prostate or patients who have metastatic carcinoma of presumptive prostate origin as manifest by the presence of sclerotic bony metastases and a serum PSA level greater than the upper limit of normal
Hemoglobin level at or below 120 g/L
ECOG (Eastern Cooperative Oncology Group) Performance status of 0-2.
No known or suspected CNS metastasis (Cancer that has spread from the original (primary) tumor to the central nervous system)
No other active concurrent malignancy, other than the underlying prostate cancer which is expected to influence QoL
No blood transfusions within the last 14 days and no previous use of erythropoietin (i.e., that would impact baseline Hb)
No anemia due to factors other than cancer/radiotherapy (i.e., hemolysis or gastrointestinal bleeding, evidence of untreated folate or vitamin B12 deficiency)
No history of uncontrolled hypertension or diastolic blood pressure greater than 100 mmHg
No mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of quality-of-life questionnaires.