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

Dana-Farber Cancer Institute

Status: Terminated

Conditions: Prostate Cancer

Treatments: Procedure: biopsy; Dietary Supplement: omega-3 fatty acids

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00458549

P30CA006516 (U.S. NIH Grant/Contract)

03-116

R01CA101034 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 232 patients

Sex: Male

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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232 participants in 2 patient groups, including a placebo group

omega-3 fatty acids

Experimental group

Description:

omega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery

Treatment:

Dietary Supplement: omega-3 fatty acids

Procedure: biopsy

Corn Oil

Placebo Comparator group

Description:

Oral 8g once a day for 21 days prior to (biopsy) surgery

Treatment:

Procedure: biopsy