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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
omega-3 fatty acids
biopsy
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prostate Cancer focused on measuring stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept 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surgery referred from other institutions/doctors where their biopsy was taken and the diagnosis of prostate cancer was originally made.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.

Sites / Locations

  • Brigham and Women's Hospital
  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

omega-3 fatty acids

Corn Oil

Arm Description

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

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

Outcomes

Primary Outcome Measures

Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1)
Change in phosphorylation level of eIF2α before and after n-3 polyunsaturated fatty acid supplementation (Part 2)

Secondary Outcome Measures

Relapse-free survival (Part 2)
detectable (> 0.1ng/m1) values following an undetectable level

Full Information

First Posted
April 9, 2007
Last Updated
July 11, 2018
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00458549
Brief Title
Polyunsaturated Fatty Acids in Treating Patients With Prostate Cancer Undergoing Prostate Biopsy and/or Surgery
Official Title
Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
May 27, 2003 (Actual)
Primary Completion Date
May 14, 2009 (Actual)
Study Completion Date
May 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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. (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
omega-3 fatty acids
Arm Type
Experimental
Arm Description
omega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery
Arm Title
Corn Oil
Arm Type
Placebo Comparator
Arm Description
Oral 8g once a day for 21 days prior to (biopsy) surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3 fatty acids
Other Intervention Name(s)
OmegaRx
Intervention Description
omega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery
Intervention Type
Procedure
Intervention Name(s)
biopsy
Primary Outcome Measure Information:
Title
Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1)
Time Frame
21 Days
Title
Change in phosphorylation level of eIF2α before and after n-3 polyunsaturated fatty acid supplementation (Part 2)
Time Frame
21 Days
Secondary Outcome Measure Information:
Title
Relapse-free survival (Part 2)
Description
detectable (> 0.1ng/m1) values following an undetectable level
Time Frame
Time between surgery and the time of PSA failure 6 months and 9 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose A. Halperin, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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