Status:
TERMINATED
Polyunsaturated Fatty Acids in Treating Patients With Prostate Cancer Undergoing Prostate Biopsy and/or Surgery
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
NA
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 p...
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. (...
Eligibility Criteria
Inclusion
- 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surgery referred from other institutions/doctors where their biopsy was taken and the diagnosis of prostate cancer was originally made.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
- 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.
Key Trial Info
Start Date :
May 27 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00458549
Start Date
May 27 2003
End Date
May 1 2012
Last Update
July 13 2018
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115