Clinical trial · Observational
Factors Associated With PSA False Negative and False Positive Results and the Impact on Patient's Health.
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 outcomes 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: 1. To analyse the clinical and analytical factors associated with the presence of false positive and false negative results in PSA determinations in patients within the setting of opportunistic screening and in those with symptoms. 2. To evaluate the patient's clinical outcome, diagnostic and/or clinical and/or therapeutic interventions implemented in each patient according to the PSA value and the patient's clinical variables during the two years of follow-up. Furthermore, the investigadors will study whether this management is appropriate to the recommendations of the European Society of Urology.
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 /Blood | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Positive Prostate-Specific Antigen test result | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Positive PSA result
- description
- Men with a positive PSA test defined as: * Serum total PSA concentration is over 10 ng/ml. * Serum total PSA between 4 and 10 ng/ml if the value of the free PSA/total PSA fraction is under 25%, in at least in two determinations.
- interventionNames
- Diagnostic Test: Positive Prostate-Specific Antigen test result
- label
- Negative PSA result
- description
- Men with a negative PSA test defined as: * Serum total PSA concentration is under 10 ng/ml. * Serum total PSA between 4 and 10 ng/ml if the value of the free PSA/total PSA fraction is over 25%.
Primary outcomes (4)
- measure
- Proportion of patients with a false-positive result in the determination of serum PSA levels.
- timeFrame
- 2 years since PSA determination
- description
- False positive result of the PSA determination defined as follows: If the PSA test is positive (meaning, serum total PSA level is over 10 ng/ml or serum total PSA level between 4 and 10 ng/ml if the value of the free PSA/total PSA fraction is under 25%, in at least in two determinations) and the result of digital rectal examination and/or subsequent biopsy is negative.
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 result in a routine health examination 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 (4)
- BACKGROUNDWolf AM, Wender RC, Etzioni RB, Thompson IM, D'Amico AV, Volk RJ, Brooks DD, Dash C, Guessous I, Andrews K, DeSantis C, Smith RA; American Cancer Society Prostate Cancer Advisory Committee. American Cancer Society guideline for the early detection of prostate cancer: update 2010. CA Cancer J Clin. 2010 Mar-Apr;60(2):70-98. doi: 10.3322/caac.20066. Epub 2010 Mar 3. PMID 20200110
- BACKGROUNDChun FK, Epstein JI, Ficarra V, Freedland SJ, Montironi R, Montorsi F, Shariat SF, Schroder FH, Scattoni V. Optimizing performance and interpretation of prostate biopsy: a critical analysis of the literature. Eur Urol. 2010 Dec;58(6):851-64. doi: 10.1016/j.eururo.2010.08.041. Epub 2010 Sep 4. PMID 20884114
- BACKGROUNDMottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25. PMID 27568654
- DERIVEDBernal-Soriano MC, Parker LA, Lopez-Garrigos M, Hernandez-Aguado I, Caballero-Romeu JP, Gomez-Perez L, Alfayate-Guerra R, Pastor-Valero M, Garcia N, Lumbreras B. Factors associated with false negative and false positive results of prostate-specific antigen (PSA) and the impact on patient health: Cohort study protocol. Medicine (Baltimore). 2019 Oct;98(40):e17451. doi: 10.1097/MD.0000000000017451. PMID 31577771