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Tracking Information | |||||||||
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First Received Date † | October 4, 2005 | ||||||||
Last Updated Date | November 13, 2008 | ||||||||
Start Date † | December 2005 | ||||||||
Current Primary Outcome Measures † |
Assess the effect of oral aspirin on in vivo prostate epithelial cells. [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † |
To assess the effect of oral aspirin on in vivo prostate epithelial cells. | ||||||||
Change History | Complete list of historical versions of study NCT00234299 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||||||
Brief Title † | Effects of ASA on Prostate Tissue | ||||||||
Official Title † | In Vivo Molecular Effects of Aspirin on Prostate Tissue | ||||||||
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. |
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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. |
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Study Phase | |||||||||
Study Type † | Interventional | ||||||||
Study Design † | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study | ||||||||
Condition † | Prostate Cancer | ||||||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 60 | ||||||||
Estimated Completion Date | September 2009 | ||||||||
Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||||||
Ages | 45 Years to 74 Years | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00234299 | ||||||||
Responsible Party | Daniel W. Lin, MD / Principal Investigator, Fred Hutchinson Cancer Research Center / University of Washington / VA Puget Sound HCS | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | University of Washington | ||||||||
Collaborators †† | Fred Hutchinson Cancer Research Center | ||||||||
Investigators † |
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Information Provided By | University of Washington | ||||||||
Verification Date | November 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |