Dataset Information

A systematic review of the diagnostic accuracy of prostate specific antigen.

ABSTRACT:

Background

Prostate cancer is the fourth commonest cancer in the UK, and the incidence is rising. The reference standard for diagnosing this condition is prostate biopsy, an invasive procedure. This study systematically reviews recent literature on tPSA accuracy. The time period was restricted to ensure that the estimates referred to contemporary tPSA tests and prostate cancer reference standards. The focus of this review was restricted to European populations as tPSA levels are known to vary by population group.

Methods

Medline was searched (from 01/1998 to 01/2008) and Embase (from 01/1998 to 01/2008), which returned 3087 citations. These were assessed by 6 reviewers, who shortlisted 54 of possible relevance. 2 reviewers assessed each using the following inclusion criteria: data collection between 1998-2008; tPSA measurements for all participants; histological confirmation of the diagnosis; samples from a European population and sufficient data to calculate 2 x 2 tables. The final set of 10 included studies represented 5373 participants. Quality of the included studies was assessed in duplicate using criteria suggested by the Cochrane Collaboration. Review Manager 5.0 software was used to analyse the data, including plotting a series of summary receiver operator curve spaces (SROC).

Results

tPSA sensitivities ranged from 0.78 to 1.00 and specificities from 0.06 to 0.66. Positive likelihood ratios ranged from 0.83 to 2.90 and negative likelihood ratios ranged from 0.00 to 3.75

Conclusion

tPSA has a role to play as one of several indicators for prostate biopsy along with abnormal digital rectal examination and urinary symptoms. However, tPSA test has a high false positive and significant false negative rate. It is important that clinicians understand these limitations.

SUBMITTER: Harvey P

PROVIDER: S-EPMC2753579 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature

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Publications

A systematic review of the diagnostic accuracy of prostate specific antigen.

Harvey Philip P Basuita Amman A Endersby Deborah D Curtis Ben B Iacovidou Aphrodite A Walker Mary M

BMC urology 20090910

<h4>Background</h4>Prostate cancer is the fourth commonest cancer in the UK, and the incidence is rising. The reference standard for diagnosing this condition is prostate biopsy, an invasive procedure. This study systematically reviews recent literature on tPSA accuracy. The time period was restricted to ensure that the estimates referred to contemporary tPSA tests and prostate cancer reference standards. The focus of this review was restricted to European populations as tPSA levels are known to ...[more]

PMID: 19744336

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Project description:BackgroundProstate-specific antigen (PSA) is a commonly used test to detect prostate cancer. Attention has mostly focused on the use of PSA in screening asymptomatic patients, but the diagnostic accuracy of PSA for prostate cancer in patients with symptoms is less well understood.MethodsA systematic database search was conducted of Medline, EMBASE, Web of Science, and the Cochrane library. Studies reporting the diagnostic accuracy of PSA for prostate cancer in patients with symptoms were included. Two investigators independently assessed the titles and abstracts of all database search hits and full texts of potentially relevant studies against the inclusion criteria, and data extracted into a proforma. Study quality was assessed using the QUADAS-2 tool by two investigators independently. Summary estimates of diagnostic accuracy were calculated with meta-analysis using bivariate mixed effects regression.ResultsFive hundred sixty-three search hits were assessed by title and abstract after de-duplication, with 75 full text papers reviewed. Nineteen studies met the inclusion criteria, 18 of which were conducted in secondary care settings with one from a screening study cohort. All studies used histology obtained by transrectal ultrasound-guided biopsy (TRUS) as a reference test; usually only for patients with elevated PSA or abnormal prostate examination. Pooled data from 14,489 patients found estimated sensitivity of PSA for prostate cancer was 0.93 (95% CI 0.88, 0.96) and specificity was 0.20 (95% CI 0.12, 0.33). The area under the hierarchical summary receiver operator characteristic curve was 0.72 (95% CI 0.68, 0.76). All studies were assessed as having a high risk of bias in at least one QUADAS-2 domain.ConclusionsCurrently available evidence suggests PSA is highly sensitive but poorly specific for prostate cancer detection in symptomatic patients. However, significant limitations in study design and reference test reduces the certainty of this estimate. There is very limited evidence for the performance of PSA in primary care, the healthcare setting where most PSA testing is performed.

Project description:Background As the novel serum biomarkers, it has not been clearly clarified that the diagnostic accuracy of prostate health index (PHI) and prostate health index density (PHID) are superior to that of percentage free prostate-specific antigen (%fPSA) in detection of clinically significant prostate cancer (csPCa), especially in the gray zone. Therefore, this study aimed to compare the diagnostic value of PHI, PHID, and %fPSA for csPCa in the patients with prostate-specific antigen (PSA) >4 ng/mL and those with PSA within 4–10 ng/mL. Methods In this study, the serum samples and clinicopathological features were prospectively obtained from the patients who underwent prostate biopsy between September 2019 and December 2020. According to the inclusion criteria, the patients with total PSA (tPSA) >4 ng/mL, prostate magnetic resonance imaging or ultrasound clearly suggesting an occupying lesion were enrolled in this study. The patients with Gleason score ≥7 indicated csPCa. The receiver operating characteristic curves and the area under the curve (AUC) values were used to assess the diagnostic performance. Results Among the 296 patients (mean age 67.5 years, median tPSA 7.94 ng/mL) included in this study, there were 54 in the csPCa group (mean age 70.4 years, median tPSA 11.0 ng/mL) and 242 in the non-csPCa group (mean age 66.8 years, median tPSA 7.67 ng/mL). Based on the PSA level, there were 198 patients with PSA within the gray zone, which included 40 patients in the csPCa group and 158 in the non-csPCa group. In all patients, the sensitivity of PHID for detecting csPCa was 96.30%, and the specificity was 33.06% with the cut-off value of 0.51. Moreover, both PHID and PHI did better in the diagnosis of csPCa (AUC: 0.880 and 0.867, respectively) compared with other PSA derivative markers. Similarly, in the patients with PSA level in the gray zone, the diagnostic accuracy of PHID and PHI in predicting csPCa (AUC: 0.788 and 0.777, respectively) were better than other PSA derivative markers. Conclusions PHID presented the better diagnostic accuracy in predicting csPCa in patients with PSA in the gray zone than other PSA derivative markers, which could be a promising biomarker for making the biopsy strategy.

Project description:BackgroundThe lack of interchangeability among prostate-specific antigen (PSA) assays causes difficulties in clinical interpretation. The currently available mainstream assays for PSA were based on Western populations, but it is not clear whether these assays yield different results in prostate cancer (PCa) screening in Chinese populations.MethodsA total of 163 men with a total PSA (tPSA) level of 2-10 µg/L scheduled for prostate biopsy were enrolled in this study. The levels of the tPSA and free PSA (fPSA) were detected by the Beckman (using the Hybritech calibration), Roche, Abbott, and Mindray (using the World Health Organization's calibration). Methodological comparison were performed according to EP9-A3 of the Clinical and Laboratory Standards Institute, USA. With pathological diagnosis as the gold standard, the predictive accuracy of the biomarkers was quantified as the area under the receiver operating characteristic curve (AUC) for each of the four methods.ResultsA total of 32 PCa patients and 131 patients with benign prostate disease were included in this study. The tPSA levels detected by the Roche, Abbott, and Mindray showed good consistency with Beckman but not of the fPSA levels. Compared to the Beckman tPSA values, the measured values were 1.1% higher for Roche, 2.1% higher for Abbott, and 6.7% higher for Mindray. The fPSA levels measured by Roche, Abbott, and Mindray were 5.4% lower, 22.1% higher, and 4.6% higher than Beckman, respectively. When the tPSA was 4 ng/mL, the diagnostic performance (sensitivity, specificity, positive predictive value, negative predictive value, and missed diagnosis rate) was similar among these 4 assays. When the %fPSA was 16%, Abbott had the highest missed diagnosis rate (37.50%), while Mindray had a sensitivity of 81.25%, the highest negative predictive value (93.88%), and the lowest missed diagnosis rate (18.75%).ConclusionsWhen the tPSA level is 2-10 ng/mL, the Mindray, like the Roche and Abbott, has good consistency with the Beckman in detecting tPSA, which makes it possible to relieve the pressure of clinical interpretation. However, 4 assays using the same %fPSA cut-off may lead to diverse missed diagnosis rates for PCa screening in China.

Project description:ObjectiveTo investigate the efficacy and safety of prostate-specific antigen (PSA) testing to screen for prostate cancer.DesignSystematic review and meta-analysis.Data sourcesElectronic search of Cochrane Central Register of Controlled Trials, Web of Science, Embase, Scopus, OpenGrey, LILACS, and Medline, and search of scientific meeting abstracts and trial registers to April 2018.Eligibility criteria for selecting studiesRandomised controlled trials comparing PSA screening with usual care in men without a diagnosis of prostate cancer.Data extractionAt least two reviewers screened studies, extracted data, and assessed the quality of eligible studies. A parallel guideline committee (BMJ Rapid Recommendation) provided input on the design and interpretation of the systematic review, including selection of outcomes important to patients. We used a random effects model to obtain pooled incidence rate ratios (IRR) and, when feasible, conducted subgroup analyses (defined a priori) based on age, frequency of screening, family history, ethnicity, and socioeconomic level, as well as a sensitivity analysis based on the risk of bias. The quality of the evidence was assessed with the GRADE approach.ResultsFive randomised controlled trials, enrolling 721?718 men, were included. Studies varied with respect to screening frequency and intervals, PSA thresholds for biopsy, and risk of bias. When considering the whole body of evidence, screening probably has no effect on all-cause mortality (IRR 0.99, 95% CI 0.98 to 1.01; moderate certainty) and may have no effect on prostate-specific mortality (IRR 0.96, 0.85 to 1.08; low certainty). Sensitivity analysis of studies at lower risk of bias (n=1) also demonstrates that screening seems to have no effect on all-cause mortality (IRR 1.0, 0.98 to 1.02; moderate certainty) but may have a small effect on prostate-specific mortality (IRR 0.79, 0.69 to 0.91; moderate certainty). This corresponds to one less death from prostate cancer per 1000 men screened over 10 years. Direct comparative data on biopsy and treatment related complications from the included trials were limited. Using modelling, we estimated that for every 1000 men screened, approximately 1, 3, and 25 more men would be hospitalised for sepsis, require pads for urinary incontinence, and report erectile dysfunction, respectively.ConclusionsAt best, screening for prostate cancer leads to a small reduction in disease-specific mortality over 10 years but has does not affect overall mortality. Clinicians and patients considering PSA based screening need to weigh these benefits against the potential short and long term harms of screening, including complications from biopsies and subsequent treatment, as well as the risk of overdiagnosis and overtreatment.Systematic review registrationPROSPERO registration number CRD42016042347.

Project description:ObjectivesUltrasound (US) technology has recently made advances that have led to the development of modalities including elastography and contrast-enhanced ultrasound. The use of different US modalities in combination may increase the accuracy of PCa diagnosis. This study aims to assess the diagnostic accuracy of multiparametric ultrasound (mpUS) in the PCa diagnosis.MethodsThrough September 2023, we searched through Cochrane CENTRAL, PubMed, Embase, Scopus, Web of Science, ClinicalTrial.gov, and Google Scholar for relevant studies. We used standard methods recommended for meta-analyses of diagnostic evaluation. We plot the SROC curve, which stands for summary receiver operating characteristic. To determine how confounding factors affected the results, meta-regression analysis was used.ResultsFinally, 1004 patients from 8 studies that were included in this research were examined. The diagnostic odds ratio for PCa was 20 (95% confidence interval (CI), 8-49) and the pooled estimates of mpUS for diagnosis were as follows: sensitivity, 0.88 (95% CI, 0.81-0.93); specificity, 0.72 (95% CI, 0.59-0.83); positive predictive value, 0.75 (95% CI, 0.63-0.87); and negative predictive value, 0.82 (95% CI, 0.71-0.93). The area under the SROC curve was 0.89 (95% CI, 0.86-0.92). There was a significant heterogeneity among the studies (p < 0.01). According to meta-regression, both the sensitivity and specificity of mpUS in the diagnosis of clinically significant PCa (csPCa) were inferior to any PCa.ConclusionThe diagnostic accuracy of mpUS in the diagnosis of PCa is moderate, but the accuracy in the diagnosis of csPCa is significantly lower than any PCa. More relevant research is needed in the future.Critical relevance statementThis study provides urologists and sonographers with useful data by summarizing the accuracy of multiparametric ultrasound in the detection of prostate cancer.Key points• Recent studies focused on the role of multiparametric ultrasound in the diagnosis of prostate cancer. • This meta-analysis revealed that multiparametric ultrasound has moderate diagnostic accuracy for prostate cancer. • The diagnostic accuracy of multiparametric ultrasound in the diagnosis of clinically significant prostate cancer is significantly lower than any prostate cancer.

Dataset Information

A systematic review of the diagnostic accuracy of prostate specific antigen.

Background

Methods

Results

Conclusion

Publications

A systematic review of the diagnostic accuracy of prostate specific antigen.

Similar Datasets

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