Effects of ASA on Prostate Tissue
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||In Vivo Molecular Effects of Aspirin on Prostate Tissue|
- Assess the effect of oral aspirin on in vivo prostate epithelial cells. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Group A
Enteric coated aspirin 325mg, one tablet orally every day for six months prior to prostate biopsy.
325mg, one tablet orally, six months
Placebo Comparator: Group B
Enteric coated placebo, one tablet orally every day for six months prior to prostate biopsy.
325mg, one tablet orally every day, 6 months
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.
|United States, Washington|
|VA Puget Sound Health Care Service|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Daniel W Lin, MD||Veteran's Administration Puget Sound Health Care Service|