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Effects of ASA on Prostate Tissue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234299
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : May 25, 2016
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
Daniel Lin, University of Washington

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Aspirin Drug: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Group A
Enteric coated aspirin 325mg, one tablet orally every day for six months prior to prostate biopsy.
Drug: Aspirin
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.
Drug: Placebo
325mg, one tablet orally every day, 6 months

Primary Outcome Measures :
  1. Assess the effect of oral aspirin on in vivo prostate epithelial cells. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00234299

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United States, Washington
VA Puget Sound Health Care Service
Seattle, Washington, United States, 98108
Sponsors and Collaborators
University of Washington
Fred Hutchinson Cancer Research Center
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Principal Investigator: Daniel W Lin, MD Veteran's Administration Puget Sound Health Care Service
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Responsible Party: Daniel Lin, Chief of Uro-Oncology, University of Washington Identifier: NCT00234299    
Other Study ID Numbers: 01426-V
05-7956-V 01 ( Other Identifier: University of Washington HSD )
28526-V ( Other Identifier: University of Washington HSD )
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016
Keywords provided by Daniel Lin, University of Washington:
Preventive Therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors