Assay Standardization Bias: Different Prostate Cancer Detection Rates and Clinical Outcomes Resulting from Different Assays for Free and Total Prostate-Specific Antigen

Sotelo, René; Mora, Katherine; Pérez, Leopoldo; Novoa, John; Carmona, Oswaldo; Andrade, Robert De; Borges, Rafael E.; Parada, David; Loeb, Stacy; Catàlona, William J.

doi:10.1016/j.urology.2007.02.006

Cited by 16 publications

(7 citation statements)

References 12 publications

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“…20 Although measurement of PSA is subject to some variability by assay 21 and day-to-day variation, 22 and assignment of Gleason score is marked by a degree of interobserver variation among pathologists, 23 these measurements are likely more reproducible than determination of clinical stage and, thus, serve as more objective markers of disease severity.…”

Section: Discussionmentioning

confidence: 99%

Minimal Impact of Clinical Stage on Prostate Cancer Prognosis Among Contemporary Patients With Clinically Localized Disease

2010

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Abbreviations and Acronyms AICPurpose: Clinical staging criteria for prostate cancer were established before the advent of widespread prostate specific antigen screening and extended biopsy templates. However, clinical stage remains commonly used in the modern era to predict prostate cancer outcomes. We hypothesize that in the context of data available from a contemporary biopsy, clinical stage no longer offers meaningful independent prognostic information for clinically localized prostate cancer. Materials and Methods:We performed an analysis of men in the CaPSURE™ database with localized (clinical stage T1 or T2) prostate cancer who underwent radical prostatectomy. The usefulness of clinical stage and other clinical parameters (prostate specific antigen, biopsy Gleason score, percent of positive biopsy cores) to predict pathological outcomes and biochemical recurrence after radical prostatectomy was assessed using univariate and multivariable analyses. Results: Of the 4,899 men in the study cohort 51.9% were classified as having T1 disease and 48.1% T2 disease. On univariate analysis clinical stages T2b and T2c were associated with pathological outcomes but only stage T2b was associated with biochemical recurrence. In contrast prostate specific antigen, biopsy Gleason score and percent of positive biopsy cores were strongly associated with recurrence and adverse pathological outcomes. On multivariable analysis clinical stage was of no use in determining pathological or biochemical outcomes. Conclusions: In a multivariable model, including serum prostate specific antigen, biopsy Gleason score and percent of positive biopsy cores, clinical stage offered no independent information in predicting biochemical recurrence. The results of this study call into question the usefulness of clinical staging criteria in risk stratifying cases of localized prostate cancer treated with radical prostatectomy.

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Section: Discussionmentioning

confidence: 99%

Minimal Impact of Clinical Stage on Prostate Cancer Prognosis Among Contemporary Patients With Clinically Localized Disease

2010

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“…Kort et al recently concluded that the results of other assays also deviate from expected tPSA values if the WHO 96/670 reference preparation is applied (regression slopes between 0.99 and 1.08), showing that further efforts are needed to improve the interchangeability of tPSA assays (17,18,21 ). In addition, we emphasize that although use of a biopsy cutoff of 3.0 or 4.0 g/L is com- (4,13,29,30 ). This study and others, however, evaluated the effects of different tPSA assays, which have different performance characteristics.…”

Section: Discussionmentioning

confidence: 74%

Clinical Impact of New Prostate-Specific Antigen WHO Standardization on Biopsy Rates and Cancer Detection

Jansen¹,

Roobol²,

Bangma³

et al. 2008

Clinical Chemistry

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“…Moreover, comparability of the values depends strongly on whether the assay was standardized to the WHO calibrator or to the older Hybritech calibrator, which yield values differing by about 20% [3••,28•,29,30]. For these reasons, caution is required when comparing results from different commercial tPSA assays and from the same commercial assay standardized to different calibrators [2•,28•,29,30]. Different assays and different calibrators may explain some differences in reported PCa detection rates and clinical outcomes [28•,29–32].…”

Section: Challenges Of Prostate-specific Antigen Detectionmentioning

confidence: 99%

“…For these reasons, caution is required when comparing results from different commercial tPSA assays and from the same commercial assay standardized to different calibrators [2•,28•,29,30]. Different assays and different calibrators may explain some differences in reported PCa detection rates and clinical outcomes [28•,29–32]. …”

Section: Challenges Of Prostate-specific Antigen Detectionmentioning

confidence: 99%

Early prostate-specific antigen changes and the diagnosis and prognosis of prostate cancer

George

Matikainen

Lilja

2009

Current Opinion in Urology

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Purpose of review-To delineate how recent findings on prostate-specific antigen (PSA) can improve prediction of risk, detection, and prediction of clinical endpoints of prostate cancer (PCa).Recent findings-The widely used PSA cut-point of 4.0 ng/ml increasingly appears arbitrary, but no cut-point achieves both high sensitivity and high specificity. The accuracy of detecting PCa can be increased by additional predictive factors and combinations of markers. Evidence implies that a panel of kallikrein markers improves the specificity and reduces costs by eliminating unnecessary biopsies. Large, population-based studies have provided evidence that PSA can be used to predict PCa risk many years in advance, improve treatment selection and patient care, and predict the risk of complications and disease recurrence. However, definitive evidence is currently lacking as to whether PSA screening lowers PCa -specific mortality.Summary-PSA is still the main tool for early detection, risk stratification, and monitoring of PCa. However, PSA values are affected by many technical and biological factors. Instead of using a fixed PSA cut-point, using statistical prediction models and considering the integration additional markers may be able to improve and individualize PCa diagnostics. A single PSA measurement at early middle age can predict risk of advanced PCa decades in advance and stratify patients for intensity of subsequent screening.

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Assay Standardization Bias: Different Prostate Cancer Detection Rates and Clinical Outcomes Resulting from Different Assays for Free and Total Prostate-Specific Antigen

Cited by 16 publications

References 12 publications

Minimal Impact of Clinical Stage on Prostate Cancer Prognosis Among Contemporary Patients With Clinically Localized Disease

Minimal Impact of Clinical Stage on Prostate Cancer Prognosis Among Contemporary Patients With Clinically Localized Disease

Clinical Impact of New Prostate-Specific Antigen WHO Standardization on Biopsy Rates and Cancer Detection

Early prostate-specific antigen changes and the diagnosis and prognosis of prostate cancer

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