Prostate-Specific AntigenNCT03968692
Adequacy of Prostate-Specific Antigen (PSA) Requests
An observational study of Prostate-Specific Antigen, run by Universidad Miguel Hernandez de Elche at 2 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate-Specific Antigen
- What is being tested?
- Prostate-Specific Antigen test
- How many people
- 1,410 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2019to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- Patients who have been previously diagnosed with prostate cancer.
- Patients who are being followed for previous high PSA values.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
FISABIO
Alicante, 03658
Rocío Alfayate, PhD, 96591 ext. 9510, alfayate_roc@gva.es
- Recruiting
San Juan de Alicante Hospital
Sant Joan d'Alacant, Alicante, 03550
Maite López Garrigos, PhD, +34637848146, lopez_marter@gva.es
About this study
Official title: 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
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).
Read more
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.
Read the detailed description
Sample size and recruitment procedure:
During the last semester of 2016, 9,963 PSA determinations were carried out at Sant Joan d'Alacant Hospital and a similar number at Alicante General Hospital. Primary health centres requested most determinations. The prevalence of prostate cancer in 2012 was 527.3/100,000 men in Spain. Considering that there are about 120,000 men in each of the included Departments of Health, approximately 630 men will have the diagnosis of prostate cancer in each of them.
According to the established recommendations, a patient with prostate cancer had a PSA determination every 3-6 months. Consequently, 1,260 determinations per centre would correspond to prostate cancer patients each 6 months. Therefore, the investigators would have in each department approximately 8,740 determinations of patients without prostate cancer, and therefore, possible candidates to enter in our study.
According to a pilot study with 360 patients in which 35.6% of the requested PSA determinations do not follow the available recommendations with a 95% margin of error and 2% accuracy, the investigators will include a total of 1,410 determinations from the two centres. Hence, for the determination of specific objective 1, the investigators will select a random sample of 705 patients with a PSA determination in each centre.
From each clinical analysis laboratory, the investigators will randomly select 300 primary care analyses with PSA determination for each month from January to April 2018. The investigators will select the patients who satisfy the inclusion criteria consecutively from this list until 180 are included.
Data collection procedure:
The investigators will collect the following variables from the medical records for each patient: Demographic characteristics, setting (primary care or clinical service), PSA tests carried out in the last 12 months and PSA value, anthropometric measures and other comorbidities.
The investigators will analyze the 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. All the reviewers are trained in the use of these guidelines.
A pilot study of a sample of 30 determinations will be independently evaluated by the nine researchers the application of the determined criteria. If the agreement is high, the rest of the determinations will be evaluated separately by at least two researchers using a predesigned google form. In case of disagreement between two of the evaluators, the case will review by a third, or discussed in a joint meeting with the rest of the team.
Data analysis plan:
The analysis will be performed using the Stata IC 15 program. The investigators will estimate the frequency and 95% confidence interval of the adequacy of PSA determinations to established recommendations. The investigators will evaluate the inter-observer agreement in the determination of adequacy using the Kappa index. In order to assess the relationship with potential explanatory variables, and the magnitude of the association, the investigators will calculate prevalence ratios. If necessary, a log-binomial regression will be performed to get an adjusted analysis.
- Conditions
- Prostate-Specific Antigen
- Being tested
- Prostate-Specific Antigen test
- Keywords
- Prostatic Neoplasms, Practice Guideline, Early Detection of Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate-Specific Antigen testDiagnostic test
Prostate-Specific Antigen (PSA) test as opportunistic screening or in the presence of symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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);
- Patients in opportunistic screening defined by satisfaction of the criteria of at least one of the two guidelines:
- 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).
- 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Jan 2019
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate-Specific AntigenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario San Juan de Alicante, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Responsible party
- Principal investigator, Blanca Juana Lumbreras Lacarra, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968692
- Sponsor's protocol ID
- PI17/01883.1
- Other IDs
- PI17/01883
- Status last verified
- Jun 2019
- First submitted
- 28 May 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22752881
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03968692
- Acronym / sponsor ID
- PI17/01883.1
- Conditions
- Prostate-Specific Antigen
- Keywords
- Prostatic Neoplasms, Practice Guideline, Early Detection of Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,410 participants (estimated)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Hospital Universitario San Juan de Alicante, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sample size and recruitment procedure:
During the last semester of 2016, 9,963 PSA determinations were carried out at Sant Joan d'Alacant Hospital and a similar number at Alicante General Hospital. Primary health centres requested most determinations. The prevalence of prostate cancer in 2012 was 527.3/100,000 men in Spain. Considering that there are about 120,000 men in each of the included Departments of Health, approximately 630 men will have the diagnosis of prostate cancer in each of them.
According to the established recommendations, a patient with prostate cancer had a PSA determination every 3-6 months. Consequently, 1,260 determinations per centre would correspond to prostate cancer patients each 6 months. Therefore, the investigators would have in each department approximately 8,740 determinations of patients without prostate cancer, and therefore, possible candidates to enter in our study.
According to a pilot study with 360 patients in which 35.6% of the requested PSA determinations do not follow the available recommendations with a 95% margin of error and 2% accuracy, the investigators will include a total of 1,410 determinations from the two centres. Hence, for the determination of specific objective 1, the investigators will select a random sample of 705 patients with a PSA determination in each centre.
From each clinical analysis laboratory, the investigators will randomly select 300 primary care analyses with PSA determination for each month from January to April 2018. The investigators will select the patients who satisfy the inclusion criteria consecutively from this list until 180 are included.
Data collection procedure:
The investigators will collect the following variables from the medical records for each patient: Demographic characteristics, setting (primary care or clinical service), PSA tests carried out in the last 12 months and PSA value, anthropometric measures and other comorbidities.
The investigators will analyze the 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. All the reviewers are trained in the use of these guidelines.
A pilot study of a sample of 30 determinations will be independently evaluated by the nine researchers the application of the determined criteria. If the agreement is high, the rest of the determinations will be evaluated separately by at least two researchers using a predesigned google form. In case of disagreement between two of the evaluators, the case will review by a third, or discussed in a joint meeting with the rest of the team.
Data analysis plan:
The analysis will be performed using the Stata IC 15 program. The investigators will estimate the frequency and 95% confidence interval of the adequacy of PSA determinations to established recommendations. The investigators will evaluate the inter-observer agreement in the determination of adequacy using the Kappa index. In order to assess the relationship with potential explanatory variables, and the magnitude of the association, the investigators will calculate prevalence ratios. If necessary, a log-binomial regression will be performed to get an adjusted analysis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- Patients who have been previously diagnosed with prostate cancer.
- Patients who are being followed for previous high PSA values.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate-Specific Antigen testProstate-Specific Antigen (PSA) test as opportunistic screening or in the presence of symptoms | Diagnostic test | – |
Primary outcome
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
Time frame: 6 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Background: PubMed 22752881Bray 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate-Specific Antigen, run by Universidad Miguel Hernandez de Elche at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Blanca J Lumbreras, PhD (96591 ext. 9510, blumbreras@umh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.