Clinical trial · Interventional
Impact of Erythropoietin Treatment Versus Placebo on Quality-of-life in Patients With Advanced Prostate Cancer.
Randomized Trial of Epoetin Alfa in Men With Hormone-refractory Prostate Cancer and Anemia.
NCT00364455CI-TRIAL-00003393completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary outcome was change in Quality of Life (FACT-An Anemia scale) from baseline to 16 weeks.
Secondary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.