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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364455
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : April 27, 2010
Ontario Clinical Oncology Group (OCOG)
Information provided by:
Janssen-Ortho Inc., Canada

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.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Drug: Epoetin alfa Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Trial of Epoetin Alfa in Men With Hormone-refractory Prostate Cancer and Anemia.
Study Start Date : December 2002
Actual Study Completion Date : March 2006

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

Secondary Outcome Measures :
  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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364455

Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Ontario Clinical Oncology Group (OCOG)
Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada Identifier: NCT00364455     History of Changes
Other Study ID Numbers: CR006118
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: April 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