Smart Prostate Specific Antigen (PSA) Screening Study

NCT04782713 | Completed

• 1 other identifier: 2020-1251
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.What age to start?
2. 2.How often to repeat screening?
3. 3.What age to stop?
4. 4.What PSA threshold should trigger a biopsy referral?

Conditions

PSA; Prostate Cancer

Outcome Measures

Primary Outcomes (22)

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

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

  Monthly for 12 months prior to intervention

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

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

  Monthly for 12 months during intervention

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

  Review Pathology Laboratory Services, UI Health PSA results

  Monthly for 12 months prior to intervention

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

  Review Pathology Laboratory Services, UI Health PSA results

  Monthly for 12 months during intervention

• Number of Urology referrals 12 months prior to the intervention

  Review electronic medical records for urology referrals

  12 months prior to intervention

• Number of Urology referrals during the intervention

  Review electronic medical records for urology referrals

  12 months after intervention

• 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

  Review electronic medical records for biopsies performed

  12 months prior to the intervention

• 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

  Review electronic medical records for biopsies performed

  12 months after the intervention

• Number of prostate biopsy complications 12 months prior to the intervention

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

  12 months prior to intervention

• Number of prostate biopsy complications during the intervention

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

  12 months after intervention

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

• Benefit and harm analysis 12 months prior to the 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

  12 months prior to intervention

• Benefit and harm analysis 12 months prior to the 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

  12 months prior to intervention

• Benefit and harm analysis 12 months prior to the 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

  12 months prior to intervention

• Benefit and harm analysis during the 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.

  12 months after intervention

• Benefit and harm analysis during the 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

  12 months after intervention

• Benefit and harm analysis during the 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

  12 months after intervention

• Benefit and harm analysis during the 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

  12 months after intervention

• Number of PCPs that have confidence in discussing prostate issues 12 months prior to the 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

  12 months prior to intervention

• Number of PCPs that have confidence in discussing prostate issues during the the 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

  12 months after intervention

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

  Review electronic medical records for referral to specialty care

  12 months prior to intervention

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

  Review electronic medical records for referral to specialty care

  12 months after intervention

Study Arms (1)

PCP Evaluation of Smart PSA Screening Guidelines

OTHER

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

Other: Completing surveys

Interventions

Completing surveys OTHER

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

PCP Evaluation of Smart PSA Screening Guidelines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not a PCP employed by MSHC who provides care for male adult patients
• Male
• Age 40-75
• Clinic visit at a MSHC site
• Elevated PSA (\>4.0 ng/ml)
• 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)

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

Mile Square Health Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Gann PH, Stackhouse N, Gastala N, Ma W, Wright ME, Watson K, Stepping C, King-Lee P, Xu Z, Patel T, Abern MR. A trial of risk-adapted prostate cancer screening in a federally supported health center network serving a high-risk population. Cancer. 2026 Mar 1;132(5):e70340. doi: 10.1002/cncr.70340.

  PMID: 41761486 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Peter Gann, MD, ScD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-arm intervention with historical control trial where the direct recipients of the intervention are PCPs. There are three components to the project with corresponding data collection activities - I) PCP Evaluation of the Smart PSA Screening Guidelines

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: March 4, 2021
• Study Start: December 17, 2021
• Primary Completion: February 28, 2022
• Study Completion: November 15, 2024
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (1)