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
试验速览
- 阶段
- 不适用
- 入组人数
- 2,527
- 试验地点
- 2
- 主要终点
- Proportion of patients with a false-positive result in the determination of serum PSA levels.
研究概览
简要总结
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:
- 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.
- 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.
详细描述
Sample size and recruitment procedure:
The investigators will select a cohort of patients with positive PSA results and a cohort of patients with negative results in each centre, to be followed for two years.
According to a review by the American Cancer Society, a value of PSA of 4 ng/ml had an estimated sensitivity of 21% to detect any type of prostate cancer and a specificity of 91%. The investigators estimate a prevalence of prostate cancer in this population not lower than 5% (given that the investigators include asymptomatic and symptomatic patients), with a 95% margin of error and 2% precision, the investigators will need to include 457 patients with a negative PSA result and 865 PSA-positive patients. Taking into account a 20% possible loss during follow-up, the investigators will increase to 572 patients with a negative PSA result (286 per centre) and 1,081 patients with a positive PSA result (541 per centre) who will be selected consecutively from among those included in the cross-sectional study until the investigators reach the proposed sample size. The investigators will use the initial randomized list (which included determinations during the first 6 months of 2018) to select patients who meet both negative and positive PSA criteria and if it is necessary, the investigators will continue to review analyses until the sample size is achieved.
Data collection procedure:
The investigators will follow both cohorts (positive and negative PSA results) for two years by reviewing their medical records (every 3 months for patients with a positive PSA result and annually for patients with a negative result). The following variables will be recorded: sociodemographic and clinical characteristics (patient who has the PSA determination as part of opportunistic screening or due to the presence of symptoms suggestive of disease), other comorbidities, toxic habits, previous history of cancer, family history, present pharmacological treatment and setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with a PSA determination result in a routine health examination from the Health Department 17 and 19, in the Valencian Community (Spain)
排除标准
- •Patients who have been previously diagnosed with prostate cancer.
- •Patients who are being followed for previous high PSA values.
结局指标
主要结局
Proportion of patients with a false-positive result in the determination of serum PSA levels.
时间窗: 2 years since PSA determination
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.
Frequency of prostate cancer patients with an appropriate treatment protocol according to "EAU - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer".
时间窗: 2 years since PSA determination
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".
Proportion of patients with a false-negative result in the determination of serum PSA levels
时间窗: 2 years since PSA determination
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.
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".
时间窗: 2 years since PSA determination
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.
次要结局
未报告次要终点
研究者
Blanca Juana Lumbreras Lacarra
Professor of Preventive Medicine and Public Health
Universidad Miguel Hernandez de Elche