Polyunsaturated Fatty Acids in Treating Patients With Prostate Cancer Undergoing Prostate Biopsy and/or Surgery - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00458549

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	Drug: omega-3 fatty acids Procedure: biopsy Procedure: complementary or alternative medicine procedure Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: liquid chromatography

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jose A. Halperin, MD

Dana-Farber Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000538993, DFCI-03116
Study First Received:	April 9, 2007
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00458549
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

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009