Impact of Erythropoietin Treatment Versus Placebo on Quality-of-life in Patients With Advanced Prostate Cancer.

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Ortho Inc., Canada
• Collaborator: Ontario Clinical Oncology Group (OCOG)
• Treatments: Epoetin Alfa

Criteria

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.