Smart PSA Screening for Prostate Cancer

Overseen By Patrice King-Lee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Not male, Age outside 40-75, others

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

Compensation: Varies

Number of Visits: 3

49 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Smart PSA Screening treatment for prostate cancer?

Research suggests that PSA screening can lead to earlier detection of prostate cancer, which may improve survival rates. However, there is controversy about its overall effectiveness due to risks of overdiagnosis and overtreatment. ^{1 2 3 4 5}

Is Smart PSA Screening for Prostate Cancer safe for humans?

PSA screening for prostate cancer is generally considered safe, but it can lead to overdiagnosis and overtreatment, which may cause anxiety and unnecessary medical procedures. Some treatments following a positive PSA test, like surgery or radiation, can have side effects such as erectile dysfunction and urinary issues. ^{5 6 7 8 9}

How is the Smart PSA Screening Study treatment different from other prostate cancer treatments?

The Smart PSA Screening Study is unique because it focuses on optimizing prostate cancer screening to reduce overdetection and overtreatment, which can negatively impact quality of life. Unlike traditional methods, it aims to improve cancer detection accuracy and incorporate minimally invasive treatments and active surveillance strategies. ^{3 10 11 12 13}

What is the purpose of this trial?

This intervention includes the introduction of the Prostate Cancer Working Group (PCWG )Smart PSA Screening Guidelines and implementation of patient navigation/ care coordination for men with elevated PSA (\>4.0 ng/mL). The guidelines include: 1. What age to start? 2. How often to repeat screening? 3. What age to stop? 4. What PSA threshold should trigger a biopsy referral?

Research Team

Peter Gann, MD, ScD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This clinical trial is for male adult patients under the care of primary care physicians (PCPs) employed by MSHC. It's focused on those who might need prostate cancer screening, specifically using PSA levels as an indicator.

Inclusion Criteria

I am a primary care provider at MSHC for adult men.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of Smart PSA Screening Guidelines and patient navigation/care coordination

12 months

Surveys at baseline, 3, 6, 9, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

Treatment Details

Interventions

• Smart PSA Screening Study

Trial Overview The study is testing new guidelines for PSA screening to detect prostate cancer. This includes determining the best age to start and stop screenings, how often they should be done, and what PSA level should prompt a biopsy.

Participant Groups

Group I: PCP Evaluation of Smart PSA Screening Guidelines Experimental Treatment 1 Intervention

Completing surveys at baseline, 3, 6, 9 and 12 months

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of disease burden on cryoablation prostate-specific antigen outcomes. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Improving survival for patients with prostate cancer diagnosed in the prostate-specific antigen ERA. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Implications of stage-specific survival rates in assessing recent declines in prostate cancer mortality rates. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Twenty-year Risk of Prostate Cancer Death by Midlife Prostate-specific Antigen and a Panel of Four Kallikrein Markers in a Large Population-based Cohort of Healthy Men. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Towards personalized prostate cancer screening. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Prostate cancer prevention: do the 5-ARIs make the grade? [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Longitudinal screening for prostate cancer with prostate-specific antigen. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Prostate Cancer Screening. [2017]

9. England pubmed.ncbi.nlm.nih.gov

To be screened or not to be screened? Modeling the consequences of PSA screening for the individual. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

4-year prostate specific antigen progression and diagnosis of prostate cancer in the European Randomized Study of Screening for Prostate Cancer, section Rotterdam. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

[Screening for prostate cancer: clinical significance and future perspectives]. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Rationale for randomised trials of prostate cancer screening. The International Prostate Screening Trial Evaluation Group. [2019]

13. China pubmed.ncbi.nlm.nih.gov

What we have learned from randomized trials of prostate cancer screening. [2021]