Clinical trial · Interventional
Smart Prostate Specific Antigen (PSA) Screening Study
Smart PSA Screening Study
NCT04782713CI-TRIAL-00101413completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| PSA | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Completing surveys | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- PCP Evaluation of Smart PSA Screening Guidelines
- description
- Completing surveys at baseline, 3, 6, 9 and 12 months
- interventionNames
- Other: Completing surveys
Primary outcomes (22)
- measure
- Number of PSA tests ordered per number of clinical encounters 12 months prior to the intervention
- timeFrame
- Monthly for 12 months prior to intervention
- description
- Review Pathology Laboratory Services, Ambulatory Services Administration, UI Health for PSA orders
- measure
- Number of PSA tests ordered per number of clinical encounters during the intervention
- timeFrame
- Monthly for 12 months during intervention
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGann 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