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CompletedNCT00234299Updated May 25, 2016

Effects of ASA on Prostate Tissue

An interventional study of Aspirin and Placebo in Prostate Cancer, sponsored by University of Washington. Completed at 1 site in United States. Open to male participants aged 45 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-25.

Sponsored by University of Washington · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
45 Years to 74 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Cancer
  • Prostate
  • Preventive Therapy
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 60 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 74 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Group A

    Enteric coated aspirin 325mg, one tablet orally every day for six months prior to prostate biopsy.

    Drug: Aspirin

  • Placebo comparator
    Group B

    Enteric coated placebo, one tablet orally every day for six months prior to prostate biopsy.

    Drug: Placebo

Interventions

  • DrugAspirin

    325mg, one tablet orally, six months

  • DrugPlacebo

    325mg, one tablet orally every day, 6 months

06

What researchers measure

Primary outcomes

  1. Assess the effect of oral aspirin on in vivo prostate epithelial cells.

    Time frame: 6 months

Secondary outcomes

  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

07

Study locations

1 site
  • VA Puget Sound Health Care Service
    Seattle, Washington 98108, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00234299
Lead sponsor
University of Washington
Collaborators
Fred Hutchinson Cancer Center
Responsible party
Daniel Lin (Chief of Uro-Oncology, University of Washington) — Principal investigator
First posted
Oct 6, 2005
Start date
Dec 2005
Primary completion
Dec 2015
Completion
Dec 2015
Last update
May 25, 2016

Study contacts

Daniel W Lin, MD
principal investigator · Veteran's Administration Puget Sound Health Care Service

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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