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

Prostate Cancer Clinical Trial

Official title:

Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00458549
• Other study ID #: 03-116
• Secondary ID: R01CA101034P30CA
• Status: Terminated
• Phase: N/A
• Start date: May 27, 2003
• Est. completion date: May 1, 2012

Study information

• Verified date: July 2018
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 232
• Est. completion date: May 1, 2012
• Est. primary completion date: May 14, 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Procedure:
• biopsy

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of eIF2a phosphorylation and Gleason score in prostate biopsy samples (Part 1)		21 Days
Primary	Change in phosphorylation level of eIF2a before and after n-3 polyunsaturated fatty acid supplementation (Part 2)		21 Days
Secondary	Relapse-free survival (Part 2)	detectable (> 0.1ng/m1) values following an undetectable level	Time between surgery and the time of PSA failure 6 months and 9 months