Recruiting

Prostate Cancer Screening

Sponsor:

Washington University School of Medicine

Code:

NCT07109427

Conditions

Prostate Cancer

Cancer of the Prostate

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Annual PSA Health Maintenance Reminder

Study Details

Brief 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.
  • 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

Study ID

NCT07109427

Start date

Aug 11, 2025

Status verified date

Aug, 2026

Completion date

Aug 31, 2031

Anticipated

Primary completion date

Aug 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

40000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Annual PSA Health Maintenance Reminder

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.

Interventions

Annual PSA Health Maintenance Reminder

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.

Primary outcome measure

  • Change in PSA screening completion rates in the BJC East Health System [ Time Frame: Through 5 years ]

Central Contacts and Locations

Central contacts

Lannis Hall, M.D., MPH

636-916-9947lannishall@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Lannis Hall, M.D., MPH

636-916-9947lannishall@wustl.edu

Principal Investigator:

Lannis Hall, M.D., MPH

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • PSA Screening
  • Clinically Significant Prostate Cancer
  • African American men
  • Electronic Health Record

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-19.