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

This study has been completed.

First Received: August 11, 2006 Last Updated: April 23, 2009 History of Changes

Sponsor:	Janssen-Ortho Inc., Canada
Collaborator:	Ontario Clinical Oncology Group
Information provided by:	Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:	NCT00364455

Purpose

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.

Condition	Intervention	Phase
Prostate Carcinoma	Drug: Epoetin alfa	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	Randomized Trial of Epoetin Alfa in Men With Hormone-Refractory Prostate Cancer and Anemia.

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer Prostate Cancer

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Further study details as provided by Janssen-Ortho Inc., Canada:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Enrollment:	56
Study Start Date:	December 2002
Study Completion Date:	March 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364455

Sponsors and Collaborators

Janssen-Ortho Inc., Canada

Ontario Clinical Oncology Group

Investigators

Study Director:

Janssen-Ortho Inc. Clinical Trial

Janssen-Ortho Inc., Canada

More Information

No publications provided

Study ID Numbers:	CR006118
Study First Received:	August 11, 2006
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00364455 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Janssen-Ortho Inc., Canada:

Hormone refractory prostate cancer
Anemia
Quality-of-life

Additional relevant MeSH terms:

Epoetin Alfa
Neoplasms by Histologic Type
Genital Neoplasms, Male
Prostatic Diseases
Hematinics
Hematologic Agents
Urogenital Neoplasms
Genital Diseases, Male

Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010