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NCT00060398 · ClinicalTrials.gov registry record · Phase 3

Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer

A Phase 3 study of Prostate Cancer and Fatigue, sponsored by Eastern Cooperative Oncology Group.

Completed
Registry status
Phase 3
Development phase
282
Enrollment target
20
Study locations

NCT00060398: Completed Phase 3 study of Prostate Cancer and Fatigue, sponsored by Eastern Cooperative Oncology Group.

NCT00060398 is a Phase 3 study of Prostate Cancer and Fatigue that has completed, run by Eastern Cooperative Oncology Group. The registered enrollment target is 282 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00060398, a Phase 3 study of Prostate Cancer and Fatigue, has completed, sponsored by Eastern Cooperative Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
282 participants
Enrollment target
20
Study locations

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.

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

FieldValue
Enrollment Target 282 participants
Start Date 2004-09-29
Phase Phase 3
Eastern Cooperative Oncology Group

141 total trials

What the finished NCT00060398 record still lists

NCT00060398 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (54% lower).

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.

NCT00060398 names 20 study sites across 5 states, led by Colorado, Illinois, Georgia.

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.

What interventions are being tested in trial NCT00060398?

The interventions under investigation include: dexamethasone (DRUG), epoetin alfa (BIOLOGICAL).

Who is sponsoring clinical trial NCT00060398?

This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00060398's enrollment target sits among peer trials

282 174th of 735 higher than 562 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00060398, the US trial registry maintained by the National Library of Medicine. NCT00060398 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.