Effects of ASA on Prostate Tissue - Full Text View

Sponsors and Collaborators:	University of Washington Fred Hutchinson Cancer Research Center
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00234299

Purpose

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 Drug: Placebo

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Acetylsalicylic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	In Vivo Molecular Effects of Aspirin on Prostate Tissue

Further study details as provided by University of Washington:

Primary Outcome Measures:

Assess the effect of oral aspirin on in vivo prostate epithelial cells. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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. [ 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 ]

Estimated Enrollment:	60
Study Start Date:	December 2005
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Active Comparator Enteric coated aspirin 325mg, one tablet orally every day for six months prior to prostate biopsy.	Drug: Aspirin 325mg, one tablet orally, six months
Group B: Placebo Comparator Enteric coated placebo, one tablet orally every day for six months prior to prostate biopsy.	Drug: Placebo 325mg, one tablet orally every day, 6 months

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.

Eligibility

Ages Eligible for Study:	45 Years to 74 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234299

Contacts

Contact: Daniel W Lin, MD	206-764-2265	dlin@u.washington.edu
Contact: Crystal A Kimmie, BS	206-277-5598	crystal.kimmie@va.gov

Locations

United States, Washington
VA Puget Sound Health Care Service	Recruiting
Seattle, Washington, United States, 98108
Contact: Daniel W Lin, MD 206-764-2265 dlin@u.washington.edu
Contact: Crystal A Kimmie, BS 206-277-5598 crystal.kimmie@va.gov
Principal Investigator: Daniel W Lin, MD

Sponsors and Collaborators

University of Washington

Fred Hutchinson Cancer Research Center

Investigators

Principal Investigator:

Daniel W Lin, MD

Veteran's Administration Puget Sound Health Care Service

More Information

Responsible Party:	Fred Hutchinson Cancer Research Center / University of Washington / VA Puget Sound HCS ( Daniel W. Lin, MD / Principal Investigator )
Study ID Numbers:	05-7956-01
Study First Received:	October 4, 2005
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00234299
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

Cancer
Prostate
Preventive Therapy

Study placed in the following topic categories:

Aspirin
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents
Neoplasms

Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009