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: 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
- 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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1)
Jose A. Halperin, MD
Dana-Farber Cancer Institute
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Dana-Farber/Brigham and Women's Cancer Center||Boston, Massachusetts 02115|