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

NCT00364455 | Completed Phase 3

• 1 other identifier: CR006118
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostate; Carcinoma

Keywords

Hormone refractory prostate cancer; Anemia; Quality-of-life

Outcome Measures

Primary Outcomes (1)

• The primary outcome was change in Quality of Life (FACT-An Anemia scale) from baseline to 16 weeks.

Secondary Outcomes (1)

• 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.

Interventions

Epoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead
• Ontario Clinical Oncology Group (OCOG): collaborator

MeSH Terms

Conditions

Carcinoma; Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Janssen-Ortho Inc. Clinical Trial

  Janssen-Ortho Inc., Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: December 1, 2002
• Study Completion: March 1, 2006
• Last Updated: April 27, 2010

Record last verified: 2010-04