Effects of ASA on Prostate Tissue

In Vivo Molecular Effects of Aspirin 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 Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Aspirin; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess the effect of oral aspirin on in vivo prostate epithelial cells.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	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).	6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Daniel W Lin, MD, Veteran's Administration Puget Sound Health Care Service

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 4, 2005
• First Submitted That Met QC Criteria: October 4, 2005
• First Posted (Estimate): October 6, 2005

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: May 24, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Cancer; Prostate; Preventive Therapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 01426-V; 05-7956-V 01 (Other Identifier: University of Washington HSD); 28526-V (Other Identifier: University of Washington HSD)