PSA Screening Reminders for Prostate Cancer

Overseen By Lannis Hall, M.D., MPH

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Prostate cancer history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve prostate cancer screening by using annual PSA (Prostate-Specific Antigen) Health Maintenance Reminders and decision-making tools for doctors. The goal is to catch cancer early without diagnosing too many non-threatening cases. Men who receive care within the BJC Health System, have seen a primary care doctor this year, and don't have a history of prostate cancer are good candidates. Those at high risk, such as African American men or those with a family history of certain cancers, are especially encouraged to consider joining.

As an unphased trial, this study offers participants the chance to contribute to innovative screening methods that could enhance early detection and decision-making in prostate cancer care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for PSA screening?

Research has shown that using a yearly PSA (prostate-specific antigen) reminder for health check-ups is generally safe. Related studies indicate that this method is well-received, as it primarily involves reminders and discussions between patients and their doctors. Reports of serious side effects are absent since it doesn't involve new medications or invasive procedures. Instead, it encourages conversations about the pros and cons of prostate cancer screening. This approach helps ensure screenings occur at the right time, reducing the risk of missing a diagnosis without causing unnecessary stress or tests. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the annual PSA Health Maintenance Reminder because it leverages technology to enhance prostate cancer screening practices. Unlike traditional methods where patients might not receive timely advice or reminders, this digital alert in the electronic health record prompts primary care providers to discuss the pros and cons of prostate cancer screening with their patients. This proactive approach is designed to facilitate shared decision-making, ensuring that patients are more informed about their health choices. By integrating directly into the existing healthcare workflow, it aims to improve screening rates and potentially catch prostate cancer earlier in high-risk individuals.

What evidence suggests that the annual PSA health maintenance reminder is effective for prostate cancer screening?

Research has shown that reminders in electronic health records can guide prostate cancer screening. In this trial, participants will receive an annual PSA health maintenance reminder to encourage more discussions between patients and doctors about the pros and cons of PSA screening. This method seeks to detect prostate cancer early while avoiding unnecessary treatments. Studies suggest that when patients and doctors decide on screening together, it can lead to better outcomes. Ultimately, these reminders ensure that PSA testing is done carefully and appropriately. ^{6 7 8 9 10}

Who Is on the Research Team?

Lannis Hall, M.D., MPH

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for men who are part of a 10-hospital system, potentially at risk for prostate cancer. It's designed to see if annual reminders about PSA screening can help catch cancer early without overdiagnosing. Specific eligibility details aren't provided, but typically participants would need to be within the recommended age range for screening and not have prior prostate cancer diagnosis.

Inclusion Criteria

I am male.

I am a man aged between 50 and 75.

I am at high risk for prostate cancer due to my age, race, family history, or a known genetic mutation.

Exclusion Criteria

I have never had prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of an annual health maintenance reminder for PSA screening, encouraging shared decision-making between PCPs and patients

5 years

Annual visits (in-person or virtual)

Follow-up

Participants are monitored for changes in PSA screening completion rates and agreement between 3T MRI and biomarker test results

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Annual PSA Health Maintenance Reminder

Trial Overview The trial is testing whether an electronic reminder for yearly PSA tests improves screening rates and helps with early detection of prostate cancer. The reminder includes referral thresholds based on clinical risk and decision support tools to follow guidelines more closely.

How Is the Trial Designed?

Group I: Annual PSA Health Maintenance Reminder Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07109427

Impact of an Electronic Health Record Maintenance Alert ... ... prostate cancer screening is both ... The annual health maintenance reminder does not mandate PSA screening for eligible patients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1558767324001496

National Trends in PSA Cancer Screening With Parallel ... The Centers for Disease Control Behavioral Risk Factor Surveillance System is a national database of surveys on health-related behaviors and preventive medical ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7858708/

Implementation and Impact of a Risk-Stratified Prostate ... Conduct a preliminary analysis of the implementation of a risk-stratified prostate cancer screening algorithm in a single health care system.

4. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/prostate-cancer-screening

Recommendation: Prostate Cancer: Screening For men aged 55 to 69 years, the decision to undergo periodic prostate-specific antigen (PSA)-based screening for prostate cancer should be an ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/411986

Delivery of Cancer Screening: How Important Is ... Among managed care enrollees eligible for cancer screening, PHE receipt is associated with completion of colorectal, breast, and prostate cancer testing.

6. patlynk.com patlynk.com/trial/NCT07109427

Electronic Health Record Alert on PSA Screening Rates An annual health maintenance reminder will be implemented for all men who meet the American Cancer Society guidelines for average- and high-risk eligibility ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12519675/

PSAzing up patient care: a quality improvement project for ... The American Cancer Society estimates that in 2025, 313 780 individuals will be diagnosed with prostate cancer, and there will be approximately ...

8. researchgate.net researchgate.net/publication/344039703_Implementation_and_Impact_of_a_Risk-Stratified_Prostate_Cancer_Screening_Algorithm_as_a_Clinical_Decision_Support_Tool_in_a_Primary_Care_Network

Implementation and Impact of a Risk-Stratified Prostate ... The proportion of men who met screening algorithm criteria increased from 49.3% (pre-implementation) to 68.0% (post-implementation) (p < 0.001); this increase ...

9. mdpi.com mdpi.com/2227-9032/13/16/2041

Early Activation of a Multilevel Prostate Cancer Screening ... Results: By June 2025, 8558 men had enrolled (8.7% uptake), 6072 were eligible; 644 (10.6%) reported a positive FH. Among those tested, 58.4% had PSA < 1 ng/mL ...

10. facebook.com facebook.com/OHCancerInstitute/posts/prevention-is-power-men-should-start-psa-screenings-at-age-45-and-if-prostate-ca/797749919302807/

Prevention is power! Men should start PSA screenings at ... The PLCO trial only had 4.5% population considered a high risk group (black men), the Goteborg showed good results for men age 50 - 64, PLCO ...