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Effects of ASA on Prostate Tissue

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Placebo
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring Cancer, Prostate, Preventive Therapy

Eligibility Criteria

45 Years - 74 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: May be on watchful waiting for low grade prostate cancer who are scheduled for biopsy to monitor disease. Have a previous diagnosis of prostatic intraepithelial neoplasia (PIN)or atypical small acinar proliferation (ASAP) before either second biopsy or even is second biopsy still has PIN or ASAP and they are to undergo a third biopsy. Extended-sector (at least 10 cores) prostate biopsy performed within three months of enrollment. Prostate tissue frozen at time of prostate biopsy (UW #04-3963-V 01) PSA less than 15. Performance status 0 or 1 by the ECOG scale. Ability to understand and willingness to sign an informed consent document. Willingness to take 325mg enteric coated aspirin daily and abstain from any other NSAID, aspirin product, or COX-2 inhibitor during the study. Willingness to abstain from any hormonal or herbal preparation indicated to affect hormone levels during the study. Exclusion Criteria: Any prior or concurrent hormonal therapy, chemotherapy, or investigational agents. Use of Finasteride, Dutasteride, saw palmetto, or any herbal/nutritional preparation indicated to affect hormone levels. Use of 325mg aspirin three or more times a week. Use of NSAIDS three or more times a week. Use of NSAIDs, Cox-2 inhibitors and/or aspirin for 6 weeks prior to study enrollment and during the 3-month intervention. Known bleeding disorder. History of gastrointestinal bleeding. History of peptic or duodenal ulcer disease. History of stroke. History of serious bleeding, including but not limited to hemorrhagic stroke, epistaxis, hematuria, hematochezia, hemorrhoidal bleeding requiring cauterization. Uncontrolled hypertension. Aspirin sensitivity or allergy. Liver disease with known ascites, varices, clotting disorder, or liver function test >1.5 normal. Anemia, thrombocytopenia, prolonged INR. Elective surgery scheduled during 3-month intervention. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, CHD presently requiring a revascularization procedure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sites / Locations

  • VA Puget Sound Health Care Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

Enteric coated aspirin 325mg, one tablet orally every day for six months prior to prostate biopsy.

Enteric coated placebo, one tablet orally every day for six months prior to prostate biopsy.

Outcomes

Primary Outcome Measures

Assess the effect of oral aspirin on in vivo prostate epithelial cells.

Secondary Outcome Measures

Changes in COX-2 and COX-2 related gene expression in prostate biopsy tissue before and after the intervention; effects of the intervention on measures of apoptosis and cell cycle; effects of the intervention on global prostate gene expression.
To measure changes in COX-2 and COX-2 related gene expression in prostate biopsy tissue before and after a 6 month intervention with enteric coated aspirin (325mg/day).

Full Information

First Posted
October 4, 2005
Last Updated
May 24, 2016
Sponsor
University of Washington
Collaborators
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00234299
Brief Title
Effects of ASA on Prostate Tissue
Official Title
In Vivo Molecular Effects of Aspirin on Prostate Tissue
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Fred Hutchinson Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aspirin affects many physiological processes through its anti-inflammatory actions. Various cancers, including prostate cancer, appear to utilize inflammatory signals to facilitate their growth and progression. We hypothesize that oral aspirin acts directly on prostate epithelial cells to alter COX-2-related metabolism and inhibit prostate cell growth.
Detailed Description
Prostate cancer is the most common non-cutaneous malignancy in men and is the second leading cause of cancer death among U.S. men. 221,000 new cases and 29,000 deaths are expected in 2003. The incidence of prostate cancer diagnosis is increasing at 3% per year. Prostate specific antigen (PSA) screening has resulted in improvements in early diagnosis of prostate cancer. However, available treatments all may have a significant negative effect on quality of life. Studies have implicated a beneficial association between ASA use and a lower risk of other types of malignancies, including stomach, esophageal, breast, ovarian, and prostate cancer. There is significant evidence to suggest that aspirin has a protective effect against prostate cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Cancer, Prostate, Preventive Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Enteric coated aspirin 325mg, one tablet orally every day for six months prior to prostate biopsy.
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Enteric coated placebo, one tablet orally every day for six months prior to prostate biopsy.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
325mg, one tablet orally, six months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
325mg, one tablet orally every day, 6 months
Primary Outcome Measure Information:
Title
Assess the effect of oral aspirin on in vivo prostate epithelial cells.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in COX-2 and COX-2 related gene expression in prostate biopsy tissue before and after the intervention; effects of the intervention on measures of apoptosis and cell cycle; effects of the intervention on global prostate gene expression.
Time Frame
6 months
Title
To measure changes in COX-2 and COX-2 related gene expression in prostate biopsy tissue before and after a 6 month intervention with enteric coated aspirin (325mg/day).
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: May be on watchful waiting for low grade prostate cancer who are scheduled for biopsy to monitor disease. Have a previous diagnosis of prostatic intraepithelial neoplasia (PIN)or atypical small acinar proliferation (ASAP) before either second biopsy or even is second biopsy still has PIN or ASAP and they are to undergo a third biopsy. Extended-sector (at least 10 cores) prostate biopsy performed within three months of enrollment. Prostate tissue frozen at time of prostate biopsy (UW #04-3963-V 01) PSA less than 15. Performance status 0 or 1 by the ECOG scale. Ability to understand and willingness to sign an informed consent document. Willingness to take 325mg enteric coated aspirin daily and abstain from any other NSAID, aspirin product, or COX-2 inhibitor during the study. Willingness to abstain from any hormonal or herbal preparation indicated to affect hormone levels during the study. Exclusion Criteria: Any prior or concurrent hormonal therapy, chemotherapy, or investigational agents. Use of Finasteride, Dutasteride, saw palmetto, or any herbal/nutritional preparation indicated to affect hormone levels. Use of 325mg aspirin three or more times a week. Use of NSAIDS three or more times a week. Use of NSAIDs, Cox-2 inhibitors and/or aspirin for 6 weeks prior to study enrollment and during the 3-month intervention. Known bleeding disorder. History of gastrointestinal bleeding. History of peptic or duodenal ulcer disease. History of stroke. History of serious bleeding, including but not limited to hemorrhagic stroke, epistaxis, hematuria, hematochezia, hemorrhoidal bleeding requiring cauterization. Uncontrolled hypertension. Aspirin sensitivity or allergy. Liver disease with known ascites, varices, clotting disorder, or liver function test >1.5 normal. Anemia, thrombocytopenia, prolonged INR. Elective surgery scheduled during 3-month intervention. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, CHD presently requiring a revascularization procedure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel W Lin, MD
Organizational Affiliation
Veteran's Administration Puget Sound Health Care Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care Service
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

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Effects of ASA on Prostate Tissue

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