Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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

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

Completing surveys

Peter Gann, MD, ScD

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?

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

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

Smart Prostate Specific Antigen (PSA) Screening Study

Smart PSA Screening Study

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

Review Pathology Laboratory Services, UI Health PSA results

Review electronic medical records for urology referrals

Review electronic medical records for biopsies performed

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

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

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

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

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

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.

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

Review electronic medical records for referral to specialty care

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Smart Prostate Specific Antigen (PSA) Screening Study	NCT04782713	PSA Prostate Cancer	Completing surv...	18 Years -	University of Illinois at Chicago
Smart Prostate Specific Antigen (PSA) Screening Study	NCT04782713	PSA Prostate Cancer	Completing surv...	18 Years -	University of Illinois at Chicago

Spots Global Cancer Trial Database for completing surveys