Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids
18 Years
N/A
Male
Prostate Cancer
Trial Information
Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids
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.
Inclusion 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
Type of Study:
Interventional
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:
No
Principal Investigator
Jose A. Halperin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
Unspecified
Study ID:
CDR0000538993
NCT ID:
NCT00458549
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
Name | Location |
|---|---|
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Dana-Farber/Brigham and Women's Cancer Center | Boston, Massachusetts 02115 |
