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
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · MINECO-FEDER
observational
1,410
1 country
2
Study Start
January 1, 2019
Actual (reported)Primary Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)May 28, 2019
Actual (reported)May 30, 2019
Actual (reported)September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Prostate-Specific Antigen (PSA) test as opportunistic screening or in the presence of symptoms
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
San Juan de Alicante Hospital
Sant Joan d'Alacant, Alicante, 03550, Spain
FISABIO
Alicante, 03658, Spain
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.
First Submitted
May 28, 2019
First Posted
May 30, 2019
Study Start
January 1, 2019
Actual (reported)Primary Completion
September 2019
Estimated (date passed)Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 13, 2019
Record last verified: 2019-06
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Source: ClinicalTrials.gov.
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