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.

Condition	Intervention
Prostate Cancer	Drug: Aspirin 325mg daily  Drug: Placebo

Further study details as provided by University of Washington:

Primary Outcomes: To assess the effect of oral aspirin on in vivo prostate epithelial cells.
Secondary Outcomes: 1. To measure changes in COX-2 and COX-2 related gene expression in prostate biopsy tissue before and after a six-month intervention with 325mg/day enteric-coated aspirin; 2. To determine the effects of 325 mg/day enteric coated aspirin on measures of apoptosis and cell cycle.; 3. To examine effects of enteric coated aspirin (325 mg/day) on global prostate gene expression.
Expected Total Enrollment:  60

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.

Ages Eligible for Study:  45 Years   -   74 Years,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• No histologically documented prostate adenocarcinoma, prostatic intraepithelial neoplasia (PIN), or atypical small acinar proliferation (ASAP) on prostate 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00234299

Daniel W Lin, MD      206-764-2265    dlin@u.washington.edu
Judith A Stenstrom, LPN,BA      206-277-4368    judy.stenstrom@med.va.gov

Washington
      VA Puget Sound Health Care Service, Seattle,  Washington,  98108,  United States

Study chairs or principal investigators

Daniel W Lin, MD,  Principal Investigator,  Veteran''''s Administration Puget Sound Health Care Service   

Study ID Numbers:  05-7956-01
Last Updated:  December 8, 2005
Record first received:  October 4, 2005
ClinicalTrials.gov Identifier:  NCT00234299
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10