PSANCT04782713
Smart Prostate Specific Antigen (PSA) Screening Study
A study testing Completing surveys in people with PSA and Prostate Cancer, run by University of Illinois at Chicago at 1 site in United States.
Trial 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. What age to start? 2. How often to repeat screening? 3. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PSA, Prostate Cancer
- What is being tested?
- Completing surveys
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2021to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Not a PCP employed by MSHC who provides care for male adult patients
- Not meeting the inclusion criteria
- Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smart 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:
- What age to start?
- How often to repeat screening?
- What age to stop?
- What PSA threshold should trigger a biopsy referral?
Read the detailed description
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
- Conditions
- PSA, Prostate Cancer
- Being tested
- Completing surveys
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completing surveysOther
Completing surveys at baseline, 3, 6, 9, and 12 months
| Study group | Role | What they receive |
|---|---|---|
| PCP Evaluation of Smart PSA Screening Guidelines | Other | Completing surveys at baseline, 3, 6, 9 and 12 months Receives: Other: Completing surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Monthly for 12 months during intervention
Number of Urology referrals 12 months prior to the intervention
Review electronic medical records for urology referrals
Measured: 12 months prior to intervention
Number of Urology referrals during the intervention
Review electronic medical records for urology referrals
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start17 Dec 2021
- Primary completion28 Feb 2022
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Gann, University of Illinois at Chicago
- Investigators
- Peter Gann, MD, ScD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782713
- Sponsor's protocol ID
- 2020-1251
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2021
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41761486
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart PSA Screening Study
- ClinicalTrials.gov ID
- NCT04782713
- Acronym / sponsor ID
- 2020-1251
- Conditions
- PSA, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What age to start?
- How often to repeat screening?
- What age to stop?
- What PSA threshold should trigger a biopsy referral?
Detailed description
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| PCP Evaluation of Smart PSA Screening Guidelines | Other | Other: Completing surveysCompleting surveys at baseline, 3, 6, 9 and 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (3 listed)
- Not a PCP employed by MSHC who provides care for male adult patients
- Not meeting the inclusion criteria
- Not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Completing surveysCompleting surveys at baseline, 3, 6, 9, and 12 months | Other | PCP Evaluation of Smart PSA Screening Guidelines |
Primary outcome
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
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
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
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
Number of Urology referrals 12 months prior to the intervention
Time frame: 12 months prior to intervention
Review electronic medical records for urology referrals
Number of Urology referrals during the intervention
Time frame: 12 months after intervention
Review electronic medical records for urology referrals
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
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
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
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
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
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
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
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
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.
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 41761486Gann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Gann, MD, ScD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Completing surveys in people with PSA and Prostate Cancer, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04782713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.