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Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
NCT00060398 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG dexamethasone
- BIOLOGICAL epoetin alfa
Study Locations (20)
Colorado
- Aurora Presbyterian Hospital — Aurora
- Boulder Community Hospital — Boulder
- Penrose Cancer Center at Penrose Hospital — Colorado Springs
- Porter Adventist Hospital — Denver
- Presbyterian - St. Luke's Medical Center — Denver
- St. Joseph Hospital — Denver
- Rose Medical Center — Denver
- CCOP - Colorado Cancer Research Program, Incorporated — Denver
- Swedish Medical Center — Englewood
- Sky Ridge Medical Center — Lone Tree
- Hope Cancer Care Center at Longmont United Hospital — Longmont
- St. Mary-Corwin Regional Medical Center — Pueblo
- North Suburban Medical Center — Thornton
Illinois
- Rush-Copley Cancer Care Center — Aurora
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago
- Hematology and Oncology Associates — Chicago
Georgia
- Winship Cancer Institute of Emory University — Atlanta
- Veterans Affairs Medical Center - Atlanta (Decatur) — Decatur
California
- Memorial Medical Center Cancer Services — Modesto
Florida
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida — Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2004-09-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00060398
The ClinicalTrials.gov registry entry for NCT00060398 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 282 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eastern Cooperative Oncology Group, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions — of which dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00060398 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Colorado, Illinois, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00060398 about?
NCT00060398 is a clinical study titled "Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer". 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 a...
What is the current status of trial NCT00060398?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 282 participants. The study started on 2004-09-29.
What conditions does trial NCT00060398 study?
This clinical trial studies the following conditions: Prostate Cancer, Fatigue, Anemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00060398?
The interventions under investigation include: dexamethasone (DRUG), epoetin alfa (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00060398?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00060398 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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