Polyunsaturated Fatty Acids in Treating Patients With Prostate Cancer Undergoing Prostate Biopsy and/or Surgery

Stopped early · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00458549

Run by

Dana-Farber Cancer Institute

People needed

232

Starts

2003-05-27

Expected to finish

2012-05-01

Last updated by the study team

2018-07-13

Who can join

Age: 18 and older, up to 120. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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surgery referred from other institutions/doctors where their biopsy was taken and the diagnosis of prostate cancer was originally made.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)

You may not qualify if…

• 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.

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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