Effects of ASA on Prostate Tissue
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|ClinicalTrials.gov Identifier: NCT00234299|
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : May 25, 2016
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Aspirin Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||In Vivo Molecular Effects of Aspirin on Prostate Tissue|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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
- Assess the effect of oral aspirin on in vivo prostate epithelial cells. [ Time Frame: 6 months ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234299
|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|