Polyunsaturated Fatty Acids in Treating Patients With Prostate Cancer Undergoing Prostate Biopsy and/or Surgery

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: NCT00458549
Recruitment Status : Unknown
Verified July 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : April 11, 2007
Last Update Posted : February 9, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect the growth of prostate cancer.

PURPOSE: This randomized clinical trial is studying polyunsaturated fatty acids in treating patients with prostate cancer undergoing prostate biopsy and/or surgery.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: omega-3 fatty acids Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: liquid chromatography Procedure: biopsy Procedure: complementary or alternative medicine procedure Not Applicable

Detailed Description:


  • Compare fatty acid analysis of red blood cells, levels of eIF2α phosphorylation, and tumor differentiation grade, as measured by Gleason score, in patients undergoing prostate biopsy. (Part 1)
  • Determine if neoadjuvant n-3 polyunsaturated fatty acids (PUFAs) induce phosphorylation of eIF2α in these patients. (Part 2)
  • Compare eIF2α phosphorylation, Gleason score, and the time to prostate-specific antigen failure in prostate tumor samples obtained from the Gelb Center of the Dana-Farber Cancer Institute prostate tissue repository. (Part 3)

OUTLINE: This is a prospective study, followed by a randomized, double-blind, placebo-controlled study, followed by a retrospective study.

  • Part 1: Patients undergo tumor biopsy and blood sample collection at baseline. Samples are analyzed by gas-liquid chromatography for determination of n-3 and n-6 polyunsaturated fatty acid (PUFA) red cell membrane concentrations. Biopsy samples are analyzed for eIF2α phosphorylation by immunohistochemistry. Some patients proceed to part 2.
  • Part 2: Patients undergo blood sampling as in part 1 with additional tumor and blood collection on day 28. Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive oral n-3 PUFAs (fish oil) once daily for 28 days prior to tumor resection.
    • Arm II (control): Patients receive oral n-6 PUFAs (corn oil) once daily for 28 days prior to tumor resection.
  • Part 3: Tumor samples and associated pathology data (Gleason score) and clinical data (PSA values and patient's outcome) are obtained from a prostate tissue repository at the Gelb Center of the Dana-Farber Cancer Institute. Samples are analyzed to correlate eIF2α phosphorylation, Gleason scores, and time to PSA failure.

PROJECTED ACCRUAL: A total of 600 patients and 1,000 stored tissue samples will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids
Study Start Date : July 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1)
  2. Change in phosphorylation level of eIF2α before and after n-3 polyunsaturated fatty acid supplementation (Part 2)

Secondary Outcome Measures :
  1. Relapse-free survival (Part 2)

Information from the National Library of Medicine

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


  • Part 1: Patients undergoing prostate biopsy at Brigham and Women's Hospital (BWH), meeting the following criteria:

    • Prostate biopsy available for analysis
    • Able to access clinical information for follow-up studies
    • Able to donate 10 mL of blood for fatty acid analysis in red blood cells
    • No concurrent diagnoses that may interfere with measurements of fatty acids in red blood cell membranes, including the following:

      • Severe anemia (i.e., hemoglobin < 9 g/dL)
      • Familial dyslipoproteinemia
      • Liver cirrhosis
      • Advanced renal failure
      • Malabsorption syndrome
      • Other disease of lipid metabolism
  • Part 2: Patients who participated in part 1 who were subsequently diagnosed with prostate cancer and are pursuing a total prostatectomy at BWH OR patients referred to BWH from independent physicians for prostate cancer surgery

    • Patients with indication for radical prostatectomy who refuse surgery or schedule it at a location other than BWH are ineligible
  • Part 3: Tissue samples from the prostate tumor registry at the Dana-Farber Cancer Institute


  • See Disease Characteristics


  • See Disease Characteristics

Information from the National Library of Medicine

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): NCT00458549

United States, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Clinical Trials Office    617-724-5200      
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Massimo Loda, MD    617-632-4001   
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Jose A. Halperin, MD Dana-Farber Cancer Institute Identifier: NCT00458549     History of Changes
Other Study ID Numbers: CDR0000538993
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: July 2008

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases