Prostate CancerNCT00234299
Effects of ASA on Prostate Tissue
A study testing Aspirin in people with Prostate Cancer, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 74 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care Service
Seattle, Washington, 98108
About this study
Official title: 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.
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.
- Conditions
- Prostate Cancer
- Being tested
- Aspirin, Placebo
- Keywords
- Cancer, Prostate, Preventive Therapy
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
325mg, one tablet orally, six months
PlaceboDrug
325mg, one tablet orally every day, 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Enteric coated aspirin 325mg, one tablet orally every day for six months prior to prostate biopsy. Receives: Drug: Aspirin |
| Group B | Placebo comparator | Enteric coated placebo, one tablet orally every day for six months prior to prostate biopsy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of oral aspirin on in vivo prostate epithelial cells.
Measured: 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.
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center
- Responsible party
- Principal investigator, Daniel Lin, University of Washington
- Investigators
- Daniel W Lin, MD, Principal investigator, Veteran's Administration Puget Sound Health Care Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234299
- Sponsor's protocol ID
- 01426-V
- Other IDs
- 05-7956-V 01, 28526-V
- Status last verified
- May 2016
- First submitted
- 4 Oct 2005
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Molecular Effects of Aspirin on Prostate Tissue
- ClinicalTrials.gov ID
- NCT00234299
- Acronym / sponsor ID
- 01426-V
- Conditions
- Prostate Cancer
- Keywords
- Cancer, Prostate, Preventive Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center
- Study start
- Dec 2005
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: AspirinEnteric coated aspirin 325mg, one tablet orally every day for six months prior to prostate biopsy. |
| Group B | Placebo comparator | Drug: PlaceboEnteric coated placebo, one tablet orally every day for six months prior to prostate biopsy. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin325mg, one tablet orally, six months | Drug | Group A |
| Placebo325mg, one tablet orally every day, 6 months | Drug | Group B |
Primary outcome
Assess the effect of oral aspirin on in vivo prostate epithelial cells.
Time frame: 6 months
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel W Lin, MD principal investigator
Veteran's Administration Puget Sound Health Care Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin in people with Prostate Cancer, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effect of oral aspirin on in vivo prostate epithelial cells. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016.