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Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids


- 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.

Inclusion Criteria


- 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


- See Disease Characteristics


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1)

Safety Issue:


Principal Investigator

Jose A. Halperin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute



Study ID:




Start Date:

July 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
Dana-Farber/Brigham and Women's Cancer Center Boston, Massachusetts  02115