Prostate Cancer
Conditions
Keywords
stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
Brief summary
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.
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.
Interventions
DIETARY_SUPPLEMENTomega-3 fatty acids
omega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery
PROCEDUREbiopsy
Sponsors
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* Men undergoing an outpatient prostate biopsy independently indicated by a physician. * Patients will be selected from the population initially studied with a prostate biopsy for possible prostate cancer * sub-group without evidence of cancer * sub-group with advanced prostate cancer beyond the currently accepted criteria for surgical treatment, * sub-group with indication of radical prostatectomy * Patients will be recruited from the population of patients from Brigham and Women's Hospital for surgery referred from other institutions/doctors where their biopsy was taken and the diagnosis of prostate cancer was originally made. These patients are not eligible for Aim 1 but will enter the randomized trial (Aim 2 with baseline)
Exclusion criteria
* Prostate biopsy patients who do not accept and sign an informed consent form to * donate ten ml of blood for fatty acid analysis in red blood cells * allow their prostate biopsy to be analyzed as discarded pathological material * authorize access to their hospital clinical information for follow up studies * Patients with a current diagnosis of a condition that might interfere with the measurements of fatty acids in red blood cell membranes such as severe anemia (less than 9g/100m1% hemoglobin \-- Or * Diseases of lipid metabolism such as familial dyslipoproteinemia, liver cirrhosis, advanced renal failure, and malabsorption syndrome. * Exclude from this study patients from (indication of radical prostatectomy) who refuse the surgical recommendation or schedule surgery at a location other than Brigham and Women's Hospital. * Patients who are not able to complete the full program will not be taken into consideration in the final data analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1) | 21 Days |
| Change in phosphorylation level of eIF2α before and after n-3 polyunsaturated fatty acid supplementation (Part 2) | 21 Days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-free survival (Part 2) | Time between surgery and the time of PSA failure 6 months and 9 months | detectable (\> 0.1ng/m1) values following an undetectable level |
Countries
United States
Outcome results
None listed