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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors screen for prostate cancer in men with higher PSA levels (a protein produced by the prostate). Researchers seek to determine when to start screening, how often to conduct it, and when a biopsy (a small tissue test) is necessary. Males aged 40 to 75 who have visited a clinic and have a PSA level over 4.0 ng/mL might be suitable candidates. The study, called the Smart PSA Screening Study, examines how new guidelines can help doctors and patients better navigate prostate cancer screenings. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could refine prostate cancer screening practices for future patients.

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 prior data suggests that the Smart PSA Screening Guidelines are safe?

Research shows that PSA (prostate-specific antigen) screening is generally safe. Studies have found that regular PSA testing can reduce the risk of dying from prostate cancer by up to 31%. A European study reported a 13% reduction in prostate cancer deaths after 23 years of regular PSA screening. This suggests that PSA screening can help detect prostate cancer early, when treatment is more manageable.

However, some studies highlight concerns about overdiagnosis, which involves identifying cancers that might not cause any problems. This can lead to unnecessary treatments, which may have side effects.

In summary, while PSA screening is generally safe and can save lives, it is important to consider both the benefits and risks. Discuss with a doctor whether PSA screening is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smart PSA Screening for prostate cancer because it aims to refine and enhance the way prostate cancer is detected. Unlike the traditional PSA tests, which can sometimes lead to over-diagnosis or unnecessary biopsies, this new approach uses advanced guidelines to better interpret PSA levels. The goal is to improve accuracy and reduce false positives, making screening less invasive and more precise. This could lead to more tailored and efficient care for patients, minimizing the stress and potential side effects of unnecessary procedures.

What evidence suggests that the Smart PSA Screening Guidelines are effective for prostate cancer screening?

Research has shown that PSA (Prostate-Specific Antigen) screening can significantly reduce deaths from prostate cancer. Studies have found that PSA screening lowers prostate cancer deaths by 13% to 31% by catching the disease early, improving survival chances. This trial will evaluate the Smart PSA Screening guidelines, which may incorporate newer tests like the 4Kscore® and the prostate health index (PHI). These advanced tests often outperform PSA alone in identifying serious cases, helping to detect the most critical cancers and potentially saving more lives. ^{1 4 6 7 8}

Who Is on the Research Team?

Peter Gann, MD, ScD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/2152?only_active=0&only_eligible=0&only_recruiting=0&per_page=100

Smart Prostate Specific Antigen (PSA) Screening Study - C... This is a single-arm intervention study to test implementation of the Smart PSA strategy plus system-level patient navigation/ care coordination ...

2. mdpi.com mdpi.com/2227-9032/13/12/1381

The Effectiveness and Harms of PSA-Based Prostate ... PSA screening reduced prostate-cancer-specific mortality by 20–31%, as reported in multiple randomized controlled trials, such as ERSPC and ProScreen, among men ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30859272/

Smarter screening for prostate cancer Results: Novel serum-based models like 4Kscore® and prostate health index (PHI) are generally better than PSA alone in detecting clinically significant cancer.

4. ecancer.org ecancer.org/en/news/27208-long-term-european-study-confirms-psa-screening-saves-lives-deaths-from-prostate-cancer-13-lower-after-23-years

Long-term European study confirms PSA screening saves ... Long-term European study confirms PSA screening saves lives, deaths from prostate cancer 13% lower after 23 years · 13% lower prostate cancer ...

5. withpower.com withpower.com/trial/phase-prostatic-neoplasms-10-2020-abfdf

Smart PSA Screening 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 ...

6. news-medical.net news-medical.net/news/20251030/Study-confirms-PSA-screening-improves-survival-and-safety.aspx

Study confirms PSA screening improves survival and safety The 23-year ERSPC trial reveals that sustained, protocolized PSA testing lowers prostate cancer deaths and improves the benefit-to-harm ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39321360/

Results after Four Years of Screening for Prostate Cancer ... In this trial, omitting biopsy in patients with negative MRI results eliminated more than half of diagnoses of clinically insignificant prostate cancer.

8. bmjopenquality.bmj.com bmjopenquality.bmj.com/content/14/4/e003423

PSAzing up patient care: a quality improvement project for ... Prostate cancer screening using prostate-specific antigen (PSA) testing is controversial due to risks of overdiagnosis and overtreatment.