Prostate CancerNCT07109427
Impact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Integrated Health System
A study testing Annual PSA Health Maintenance Reminder in people with Prostate Cancer and Cancer of the Prostate, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators propose a clinical trial to evaluate the impact of annual shared decision making for PSA screening, supported by system-level enhancements to promote evidence-based care: Defined referral thresholds within the health maintenance reminder, aligned with clinical risk stratification per NCCN guidelines. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Cancer of the Prostate
- What is being tested?
- Annual PSA Health Maintenance Reminder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to 31 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Eligibility Criteria:
- Receive care within the BJC Health System
- Have had at least one primary care physician appointment in the calendar year of PSA screening (primary care)
- Be male
- Not have a history of prostate cancer
- Meet one of the following risk criteria:
- High Risk for Prostate Cancer
- African American, between the ages of 40 and 75 (inclusive), or
- Family history of prostate, breast, ovarian, and/or pancreatic cancer, or
- Known familial germline mutation OR
- Average Risk for Prostate Cancer
- Between the ages of 50 and 75 (inclusive)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Lannis Hall, M.D., MPH, 636-916-9947, lannishall@wustl.edu
Lannis Hall, M.D., MPH
About this study
- The investigators propose a clinical trial to evaluate the impact of annual shared decision making for PSA screening, supported by system-level enhancements to promote evidence-based care:
- Defined referral thresholds within the health maintenance reminder, aligned with clinical risk stratification per NCCN guidelines.
- Enhanced clinical decision support (CDS) tools to reduce provider variation and ensure guideline-concordant screening and referral practices.
- The goal is to reduce late-stage presentation without increasing overdiagnosis-ensuring that prostate cancer screening is both accessible and clinically effective.
- Conditions
- Prostate Cancer, Cancer of the Prostate
- Being tested
- Annual PSA Health Maintenance Reminder
- Keywords
- PSA Screening, Clinically Significant Prostate Cancer, African American men, Electronic Health Record
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annual PSA Health Maintenance ReminderOther
The annual health maintenance reminder does not mandate PSA screening for eligible patients. Instead, it recommends that primary care providers (PCPs) initiate a shared decision-making discussion with their patients. As part of this conversation, patients will be informed of their individual risk factors-including race, family history, and germline mutations-and can then make an informed choice about whether to proceed with PSA screening.
| Study group | Role | What they receive |
|---|---|---|
| Annual PSA Health Maintenance Reminder | Experimental | An annual health maintenance reminder will be implemented for all men who meet the American Cancer Society guidelines for average- and high-risk eligibility criteria. The goal is to encourage their primary care provider (PCP) to engage in a shared decision-making discussion with the patient about the benefits and risks of prostate cancer screening.
This alert will appear in the health maintenance reminder section of the electronic health record (EHR).
Although all providers with access to EPIC can view the alert, it is typically the PCPs who review and take action on alerts in the health maintenance reminder section. Receives: Other: Annual PSA Health Maintenance Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PSA screening completion rates in the BJC East Health System
The overall PSA screening rate will be calculated as the number of PSA screening tests that are ordered by PCPs who will receive the alert and completed by patients within a year of the ordering date, divided by the total number of eligible patients.
Measured: Through 5 years
Secondary outcomes (13)
Proportion of men diagnosed with clinically significant prostate cancer (Gleason score ≥ 7)
Measured: Through 5 years
Incidence of advanced and metastatic disease at diagnosis of prostate cancer
Measured: Through 5 years
Incidence of early-stage prostate cancer
Measured: Through 5 years
Stage distribution of prostate cancer diagnoses
Measured: Through 5 years
Biopsy rates
Measured: Through 5 years
Percent of PSA screening ordered but not completed
Measured: Through 5 years
Median PSA at time of diagnosis
Measured: Through 5 years
Evaluate the agreement between 3T MRI and biomarker test results
The 3T MRI and biomarker tests are used to help determine whether a biopsy is necessary. The investigators will categorize the results as positive versus negative and the agreement will be gauged based on Kappa coefficient.
Measured: Through 5 years
PSA screening rate by age group
Age groups will include 40-49, 50-70, and 70-75
Measured: Through 5 years
PSA screening rate by race
Measured: Through 5 years
PSA screening rate by comorbidity burden
Measured: Through 5 years
PSA screening rate by insurance coverage
Measured: Through 5 years
PSA screening rate by provider
Measured: Through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start11 Aug 2025
- Primary completion31 Aug 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
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 Washington University School of MedicineThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lannis Hall, M.D., MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109427
- Sponsor's protocol ID
- 202507064
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Integrated Health System
- ClinicalTrials.gov ID
- NCT07109427
- Acronym / sponsor ID
- 202507064
- Conditions
- Prostate Cancer, Cancer of the Prostate
- Keywords
- PSA Screening, Clinically Significant Prostate Cancer, African American men, Electronic Health Record
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 31 Aug 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 7 Aug 2025 (actual)
- 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.
- The investigators propose a clinical trial to evaluate the impact of annual shared decision making for PSA screening, supported by system-level enhancements to promote evidence-based care:
- Defined referral thresholds within the health maintenance reminder, aligned with clinical risk stratification per NCCN guidelines.
- Enhanced clinical decision support (CDS) tools to reduce provider variation and ensure guideline-concordant screening and referral practices.
- The goal is to reduce late-stage presentation without increasing overdiagnosis-ensuring that prostate cancer screening is both accessible and clinically effective.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Annual PSA Health Maintenance Reminder | Experimental | Other: Annual PSA Health Maintenance ReminderAn annual health maintenance reminder will be implemented for all men who meet the American Cancer Society guidelines for average- and high-risk eligibility criteria. The goal is to encourage their primary care provider (PCP) to engage in a shared decision-making discussion with the patient about the benefits and risks of prostate cancer screening. This alert will appear in the health maintenance reminder section of the electronic health record (EHR). Although all providers with access to EPIC can view the alert, it is typically the PCPs who review and take action on alerts in the health maintenance reminder section. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Annual PSA Health Maintenance ReminderThe annual health maintenance reminder does not mandate PSA screening for eligible patients. Instead, it recommends that primary care providers (PCPs) initiate a shared decision-making discussion with their patients. As part of this conversation, patients will be informed of their individual risk factors-including race, family history, and germline mutations-and can then make an informed choice about whether to proceed with PSA screening. | Other | Annual PSA Health Maintenance Reminder |
Primary outcome
Change in PSA screening completion rates in the BJC East Health System
Time frame: Through 5 years
The overall PSA screening rate will be calculated as the number of PSA screening tests that are ordered by PCPs who will receive the alert and completed by patients within a year of the ordering date, divided by the total number of eligible patients.
13 secondary outcomes
Proportion of men diagnosed with clinically significant prostate cancer (Gleason score ≥ 7)
Time frame: Through 5 years
Incidence of advanced and metastatic disease at diagnosis of prostate cancer
Time frame: Through 5 years
Incidence of early-stage prostate cancer
Time frame: Through 5 years
Stage distribution of prostate cancer diagnoses
Time frame: Through 5 years
Biopsy rates
Time frame: Through 5 years
Percent of PSA screening ordered but not completed
Time frame: Through 5 years
Median PSA at time of diagnosis
Time frame: Through 5 years
Evaluate the agreement between 3T MRI and biomarker test results
Time frame: Through 5 years
PSA screening rate by age group
Time frame: Through 5 years
PSA screening rate by race
Time frame: Through 5 years
PSA screening rate by comorbidity burden
Time frame: Through 5 years
PSA screening rate by insurance coverage
Time frame: Through 5 years
PSA screening rate by provider
Time frame: Through 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lannis Hall, M.D., MPH principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Annual PSA Health Maintenance Reminder in people with Prostate Cancer and Cancer of the Prostate, run by Washington University School of Medicine 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?
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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lannis Hall, M.D., MPH (636-916-9947, lannishall@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PSA screening completion rates in the BJC East Health System (time frame: Through 5 years). 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 19 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.