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

This study has been completed.
Sponsor:
Collaborator:
Ontario Clinical Oncology Group (OCOG)
Information provided by:
Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:
NCT00364455
First received: August 11, 2006
Last updated: April 26, 2010
Last verified: April 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Trial of Epoetin Alfa in Men With Hormone-refractory Prostate Cancer and Anemia.

Resource links provided by NLM:


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 (OCOG)
Investigators
Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00364455     History of Changes
Other Study ID Numbers: CR006118
Study First Received: August 11, 2006
Last Updated: April 26, 2010
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:
Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014