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
2 other identifiers
observational
2,527
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2018
CompletedFirst Submitted
Initial submission to the registry
May 28, 2019
CompletedFirst Posted
Study publicly available on registry
June 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJune 11, 2019
June 1, 2019
2 years
May 28, 2019
June 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Proportion of patients with a false-positive result in the determination of serum PSA levels.
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.
2 years since PSA determination
Proportion of patients with a false-negative result in the determination of serum PSA levels
False negative result of the PSA determination defined as follows: If the serum PSA value is negative (meaning, serum total PSA level is under 10 ng/ml or serum total PSA between 4 and 10 ng/ml if the value of the free PSA/total PSA fraction is over 25%) and the patient is diagnosed with prostate cancer in the subsequent follow-up.
2 years since PSA determination
Frequency of patients with appropriate diagnostic interventions performed in those with a positive serum PSA value according to "EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer".
Appropriateness of diagnostic interventions is defined as strategies that satisfies or not satisfies EAU recommendations with regard to the following issues: * Recommendations for clinical diagnosis of prostate cancer. * Recommendations for repeat-biopsy imaging.
2 years since PSA determination
Frequency of prostate cancer patients with an appropriate treatment protocol according to "EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer".
Appropriate treatment protocol is defined according to the EAU recommendations with regard to the number and type of therapeutic interventions carried out after prostate cancer diagnosis. The following information will be considered: * Surgical treatments. * Radiotherapeutic treatments. * Active therapeutic options outside surgery and radiotherapy. Each patient will be classified as "Appropriate according to guideline", "more intensive than guideline" or "less intensive than guideline".
2 years since PSA determination
Study Arms (2)
Positive PSA result
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.
Negative PSA result
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%.
Interventions
Positive PSA test result as part of opportunistic screening or due to the presence of symptoms suggestive of disease.
Eligibility Criteria
Men over 18 from the Health Department 17 and 19, in the Valencian Community (these include General University Hospital of Sant Joan d'Alacant and General University Hospital of Alicante, respectively). These are referral hospitals for all individuals living in their catchment areas and belong to the National Health Care System (the majority of the population in Spain uses the National Health System (NHS) as the main medical service (the publicly funded insurance scheme covers 98.5% of the Spanish population). The investigators have not established maximum age limit.
You may qualify if:
- Patients with a PSA determination result in a routine health examination from the Health Department 17 and 19, in the Valencian Community (Spain)
You may not qualify if:
- Patients who have been previously diagnosed with prostate cancer.
- Patients who are being followed for previous high PSA values.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
San Juan de Alicante Hospital
Sant Joan d'Alacant, Alicante, 03550, Spain
FISABIO
Alicante, 03658, Spain
Related Publications (4)
Wolf 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: 20200110BACKGROUNDChun 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: 20884114BACKGROUNDMottet 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: 27568654BACKGROUNDBernal-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: 31577771DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Preventive Medicine and Public Health
Study Record Dates
First Submitted
May 28, 2019
First Posted
June 7, 2019
Study Start
July 18, 2018
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
June 11, 2019
Record last verified: 2019-06