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

NCT00458549 | Terminated

• 3 other identifiers: 03-116R01CA101034P30CA006516
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Relapse-free survival (Part 2)

  Time between surgery and the time of PSA failure 6 months and 9 months

Study Arms (2)

omega-3 fatty acids

EXPERIMENTAL

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

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

Corn Oil

PLACEBO COMPARATOR

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

Procedure: biopsy

Interventions

omega-3 fatty acids DIETARY_SUPPLEMENT

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

Also known as: OmegaRx

omega-3 fatty acids

biopsy PROCEDURE

Corn Oil; omega-3 fatty acids

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fatty Acids, Omega-3; Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jose A. Halperin, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: May 27, 2003
• Primary Completion: May 14, 2009
• Study Completion: May 1, 2012
• Last Updated: July 13, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)