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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00458549
First received: April 9, 2007
Last updated: February 6, 2009
Last verified: July 2008
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1) [ Designated as safety issue: No ]
  • Change in phosphorylation level of eIF2α before and after n-3 polyunsaturated fatty acid supplementation (Part 2) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse-free survival (Part 2) [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: July 2006
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • See Disease Characteristics

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458549

Locations
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    massimo_loda@dfci.harvard.edu   
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Jose A. Halperin, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00458549     History of Changes
Other Study ID Numbers: CDR0000538993, DFCI-03116
Study First Received: April 9, 2007
Last Updated: February 6, 2009
Health Authority: Unspecified

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 22, 2014