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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014