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

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

Study Type: Interventional
Study Design: Allocation: Randomized
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00364455

Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Ontario Clinical Oncology Group (OCOG)
Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada
  More Information Identifier: NCT00364455     History of Changes
Other Study ID Numbers: CR006118
Study First Received: August 11, 2006
Last Updated: April 26, 2010

Keywords provided by Janssen-Ortho Inc., Canada:
Hormone refractory prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Epoetin Alfa
Hematinics processed this record on April 24, 2017