Effects of ASA on Prostate Tissue

NCT00234299 | Completed DMC

• 3 other identifiers: 01426-V05-7956-V 0128526-V
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Cancer; Prostate; Preventive Therapy

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: Aspirin

Group B

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Aspirin DRUG

325mg, one tablet orally, six months

Group A

Placebo DRUG

325mg, one tablet orally every day, 6 months

Group B

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Fred Hutchinson Cancer Center: collaborator

Study Sites (1)

VA Puget Sound Health Care Service

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Daniel W Lin, MD

  Veteran's Administration Puget Sound Health Care Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Uro-Oncology

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 6, 2005
• Study Start: December 1, 2005
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

US (1)