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
2 other identifiers
observational
1,410
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Shorter than P25 for all trials
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
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 28, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJune 13, 2019
June 1, 2019
8 months
May 28, 2019
June 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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).
6 months
Interventions
Prostate-Specific Antigen (PSA) test as opportunistic screening or in the presence of symptoms
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). We have not established maximum age limit.
You may qualify if:
- 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).
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 (1)
Bray 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: 22752881BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- 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
May 30, 2019
Study Start
January 1, 2019
Primary Completion
September 1, 2019
Study Completion
December 1, 2019
Last Updated
June 13, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share