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Completed

NCT Number: NCT04782713

Smart Prostate Specific Antigen (PSA) Screening Study

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?

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Key information

Conditions

PsA Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mile Square Health Center

Chicago, Illinois, 60612, United States

About this study

Primary care providers (PCP) hold the key to implementing effective early detection of Prostate Cancer (PCa), but uncertainty about how to use PSA for screening without causing undue overtreatment of indolent cancer, has greatly inhibited implementation, even in high-risk communities. This is a single-arm intervention study to test implementation of the Smart PSA strategy plus system-level patient navigation/ care coordination in the Mile Square Health Center(MSHC), in order to: a) identify barriers and facilitators to inform implementation of care, b) evaluate the impact on provider confidence regarding prostate cancer screening, and, c) measure its effect on observed PSA levels, biopsy referral rates, and biopsy outcomes.

100 PCPs employed by MSHC who provide care for male adults will be asked to participate in surveys at baseline, (prior to an in-service training) and at 3,6, 9 and 12 months. The surveys will use 5-point Likert scales to assess the respondent's self-report of their knowledge regarding PSA screening, attitudes, behavior; and confidence in presenting the issue, discussing it with patients, interpreting results and making recommendations based on them; and to elicit comments on how to improve implementation.

Historical data of 4500 patients covering a one year period prior to the intervention will be used to measure the impact of the intervention on measurable outcomes

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for PCP:

  • PCP employed by MSHC who provides care for male adult patients

Exclusion criteria

for PCP:

  • Not a PCP employed by MSHC who provides care for male adult patients

Inclusion criteria

for Patient navigator/care coordinator:

  • Male
  • Age 40-75
  • Clinic visit at a MSHC site
  • Elevated PSA (>4.0 ng/ml)

Exclusion criteria

for Patient navigator/care coordinator:

  • Not meeting the inclusion criteria

Inclusion criteria

for chart and database review:

  • Male
  • Age 40-75
  • Clinic visit at a MSHC site from date of study start through 12 months (comparison of 12-month intervention period to periods before and after intervention implementation)

Exclusion criteria

for chart and database review:

  • Not meeting the inclusion criteria

Treatment and study plan

completing surveys

Other

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

Primary outcomes

  1. Number of PSA tests ordered per number of clinical encounters 12 months prior to the intervention

    Time frame: Monthly for 12 months prior to intervention

    Review Pathology Laboratory Services, Ambulatory Services Administration, UI Health for PSA orders

  2. Number of PSA tests ordered per number of clinical encounters during the intervention

    Time frame: Monthly for 12 months during intervention

    Review Pathology Laboratory Services, Ambulatory Services Administration, UI Health for PSA orders

  3. Number of PSA levels categorized as <4.0, 4.0-10.0 and >10.0 12 month prior to the intervention

    Time frame: Monthly for 12 months prior to intervention

    Review Pathology Laboratory Services, UI Health PSA results

  4. PSA levels categorized as <4.0, 4.0-10.0 and >10.0 during the intervention

    Time frame: Monthly for 12 months during intervention

    Review Pathology Laboratory Services, UI Health PSA results

  5. Number of Urology referrals 12 months prior to the intervention

    Time frame: 12 months prior to intervention

    Review electronic medical records for urology referrals

  6. Number of Urology referrals during the intervention

    Time frame: 12 months after intervention

    Review electronic medical records for urology referrals

  7. Number of prostate biopsies performed using the risk levels of the National Comprehensive Cancer Network (NCCN) of very low, Favorable intermittent, Unfavorable intermittent, High, very high 12 months prior to the intervention

    Time frame: 12 months prior to the intervention

    Review electronic medical records for biopsies performed

  8. Number of prostate biopsies performed using the risk levels of the National Comprehensive Cancer Network (NCCN) of very low, Favorable intermittent, Unfavorable intermittent, High, very high during the intervention

    Time frame: 12 months after the intervention

    Review electronic medical records for biopsies performed

  9. Number of prostate biopsy complications 12 months prior to the intervention

    Time frame: 12 months prior to intervention

    Review electronic medical records and pharmacy database for biopsy complications using NCI Common Toxicity Criteria to rate complications from mild to life-threatening

  10. Number of prostate biopsy complications during the intervention

    Time frame: 12 months after intervention

    Review electronic medical records and pharmacy database for biopsy complications using NCI Common Toxicity Criteria to rate complications from mild to life-threatening

  11. Benefit and harm analysis 12 months prior to the intervention

    Time frame: 12 months prior to intervention

    Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient diagnosed per NCCN: Very Low, Low, Favorable intermediate, Unfavorable Intermediate, High, Very High. Subgroup analyses by age, race and previous screening history will be performed. Attention will be focused on relative changes in the number of clinically significant but treatable cases to the number of clinically insignificant cases. Clinically significant but treatable cases will be defined as NCCN Intermediate (thus all localized Gleason 7); clinically insignificant cases will be defined as NCCN Very Low (PSA<10, Gleason grade ≤ 6, T1c, < 3 positive cores, no core > 50% cancer, PSA density < 0.15

  12. Benefit and harm analysis 12 months prior to the intervention

    Time frame: 12 months prior to intervention

    Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient based on age and race

  13. Benefit and harm analysis 12 months prior to the intervention

    Time frame: 12 months prior to intervention

    Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient based on previous screening history

  14. Benefit and harm analysis 12 months prior to the intervention

    Time frame: 12 months prior to intervention

    Compare the number of clinically significant but treatable cases to the number of clinically insignificant cases. Clinically significant but treatable cases will be defined as NCCN Intermediate with localized Gleason grade 7, clinically insignificant cases will be defined as NCCN Very Low PSA<10, Gleason grade ≤ 6, T1c, < 3 positive cores, no core > 50% cancer, PSA density < 0.15

  15. Benefit and harm analysis during the intervention

    Time frame: 12 months after intervention

    Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient diagnosed per NCCN: Very Low, Low, Favorable intermediate, Unfavorable Intermediate, High, Very High.

  16. Benefit and harm analysis during the intervention

    Time frame: 12 months after intervention

    Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient based on age and race

  17. Benefit and harm analysis during the intervention

    Time frame: 12 months after intervention

    Assess the Cancer of the Prostate Risk Assessment (CAPRA) score and National Comprehensive Cancer Network (NCCN) risk levels for each patient based on previous screening history

  18. Benefit and harm analysis during the intervention

    Time frame: 12 months after intervention

    Compare the number of clinically significant but treatable cases to the number of clinically insignificant cases. Clinically significant but treatable cases will be defined as NCCN Intermediate with localized Gleason grade 7, clinically insignificant cases will be defined as NCCN Very Low PSA<10, Gleason grade ≤ 6, T1c, < 3 positive cores, no core > 50% cancer, PSA density < 0.15

  19. Number of PCPs that have confidence in discussing prostate issues 12 months prior to the intervention

    Time frame: 12 months prior to intervention

    Analyses of graphing mean trajectories in response to repeat surveys among PCPs at baseline, 3, 6, 9 and 12 months. Subgroup analyses will compare responses stratified by gender, years in practice, race and site

  20. Number of PCPs that have confidence in discussing prostate issues during the the intervention

    Time frame: 12 months after intervention

    Analyses of graphing mean trajectories in response to repeat surveys among PCPs at baseline, 3, 6, 9 and 12 months. Subgroup analyses will compare responses stratified by gender, years in practice, race and site

  21. Number of patients referred to specialty care 12 months prior to patient navigation/ care coordination

    Time frame: 12 months prior to intervention

    Review electronic medical records for referral to specialty care

  22. Number of patients referred to specialty care through patient navigation/ care coordination during the intervention

    Time frame: 12 months after intervention

    Review electronic medical records for referral to specialty care

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

Smart PSA Screening Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Mar 4, 2021
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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