Adequacy of Prostate-Specific Antigen (PSA) Requests

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1410 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Factors Associated With PSA False Negative and False Positive Results and the Impact on Patient's Health.

NCT03978299

Prostate-Specific Antigen /Blood

UNKNOWN

Test Semiquantitative Prostate Specific Antigen (PSA)

NCT00853710

Prostate Cancer Prostatic Neoplasms Prostatic Diseases

COMPLETED NA

Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer

NCT03957252

Prostate Cancer

ACTIVE_NOT_RECRUITING

PSMA PET/CT for Biochemical Recurrence Detection in Patients With Prostate Cancer

NCT04983459

Prostatic Neoplasms Recurrence

COMPLETED

Impact on Quality of Life 3 Years After Diagnosis of Prostate Cancer

NCT02854982

Prostatic Neoplasms Quality of Life

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate-Specific Antigen

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prostate-Specific Antigen test

Prostate-Specific Antigen (PSA) test as opportunistic screening or in the presence of symptoms

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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).