Clinical trial · Observational
Adequacy of Prostate-Specific Antigen (PSA) Requests
Study of the Adequacy of the Requests of Prostate-Specific Antigen (PSA), Factors Associated With the False Negative and Positive Results and the Impact on Patient's Health
- 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)
Objectives. The primary aim of this study is to evaluate the characteristics of the determination of PSA for the early detection of prostate cancer or in the presence of symptoms, in general practice in two health departments of the Valencian Community (Spain). Specific objectives: * To describe the PSA determinations that are performed in clinical practice, with the exception of patients with prostate cancer or who are being followed for previous high PSA values. * To study the adequacy of PSA requests according to the available recommendations, considering sociodemographic and clinical aspects of the patient, such as the time interval since the last PSA test. The investigators will randomly select patients from the Health Departments 17 and 19, in the Valencian Community (Spain) with a PSA request from Primary health centres.
Conditions
Conditions (1)
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-Specific Antigen | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate-Specific Antigen test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Appropriateness of PSA determinations according to the criteria established by the clinical practice guidelines of the EAU, and the May 2018 update of the USPSTF
- timeFrame
- 6 months
- description
- We define appropriateness of the PSA determination as follows: 1. Presence of symptoms suggestive of prostate pathology (difficulty starting to urinate; weak or interrupted urine flow; frequent urination, especially at night; difficulty emptying the bladder completely; pain or burning when urinating; blood in the urine or semen; persistent pain in the back, hips, or pelvis; pain when ejaculating, and erectile dysfunction); 2. Patients in opportunistic screening defined by satisfaction of the criteria of at least one of the two guidelines: 1. Age 55-69 years (USPSTF) or older than 50 years and a life expectancy of at least 10 years, provided that have not had a PSA determination in the last 24 months (EAU). 2. Patients under 55 years of age (USPSTF) or patients from 45 to 50 years old with a family history of first degree and/or African American race, provided that have not had a PSA determination in the last 24 months (EAU).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a PSA determination requested in a routine health examination from primary health centers from the Health Department 17 and 19, in the Valencian Community (Spain). Exclusion Criteria: * Patients who have been previously diagnosed with prostate cancer. * Patients who are being followed for previous high PSA values.
References
Publications (1)
- BACKGROUNDBray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26. PMID 22752881