Carcinoma Clinical Trial
Official title:
Randomized Trial of Epoetin Alfa in Men With Hormone-refractory Prostate Cancer and Anemia.
Verified date | April 2010 |
Source | Janssen-Ortho Inc., Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | March 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen-Ortho Inc., Canada | Ontario Clinical Oncology Group (OCOG) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome was change in Quality of Life (FACT-An Anemia scale) from baseline to 16 weeks. | |||
Secondary | 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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