Startseite Individual risk prediction of high grade prostate cancer based on the combination between total prostate-specific antigen (PSA) and free to total PSA ratio
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Individual risk prediction of high grade prostate cancer based on the combination between total prostate-specific antigen (PSA) and free to total PSA ratio

  • Simona Ferraro EMAIL logo , Davide Biganzoli , Roberta Simona Rossi , Franco Palmisano , Marco Bussetti , Enrica Verzotti , Andrea Gregori , Filippo Bianchi , Marco Maggioni , Ferruccio Ceriotti ORCID logo , Cristina Cereda , Gianvincenzo Zuccotti , Peter Kavsak , Mario Plebani ORCID logo , Giuseppe Marano und Elia Mario Biganzoli EMAIL logo
Veröffentlicht/Copyright: 27. Januar 2023
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 61 Heft 7

Abstract

Objectives

Clinical practice guidelines endorse the stratification of prostate cancer (PCa) risk according to individual total prostate-specific antigen (tPSA) values and age to enhance the individual risk-benefit ratio. We defined two nomograms to predict the individual risk of high and low grade PCa by combining the assay of tPSA and %free/tPSA (%f/tPSA) in patients with a pre-biopsy tPSA between 2 and 10 μg/L.

Methods

The study cohort consisted of 662 patients that had fPSA, tPSA, and a biopsy performed (41.3% with a final diagnosis of PCa). Logistic regression including age, tPSA and %f/tPSA was used to model the probability of having high or low grade cancer by defining 3 outcome levels: no PCa, low grade (International Society of Urological Pathology grade, ISUP<3) and high grade PCa (ISUP≥3).

Results

The nomogram identifying patients with: (a) high vs. those with low grade PCa and without the disease showed a good discriminating capability (∼80%), but the calibration showed a risk of underestimation for predictive probabilities >30% (a considerable critical threshold of risk), (b) ISUP<3 vs. those without the disease showed a discriminating capability of 63% and overestimates predictive probabilities >50%. In ISUP 5 a possible loss of PSA immunoreactivity has been observed.

Conclusions

The estimated risk of high or low grade PCa by the nomograms may be of aid in the decision-making process, in particular in the case of critical comorbidities and when the digital rectal examinations are inconclusive. The improved characterization of the risk of ISUP≥3 might enhance the use for magnetic resonance imaging in this setting.

Keywords: high grade; nomogram; risk; risk-benefit ratio; rule-in
Corresponding author: Simona Ferraro, Center of Functional Genomics and Rare Diseases, Department of Pediatrics, Buzzi Children’s Hospital, 20154 Milan, Italy, E-mail: ; and Elia Mario Biganzoli, Medical Statistics Unit, Department of Biomedical and Clinical Sciences L. Sacco, “Luigi Sacco” University Hospital, University of Milan, Milan, Italy, E-mail:
Simona Ferraro and Davide Biganzoli contributed equally to this work. Giuseppe Marano and Elia Mario Biganzoli contributed equally to this work as senior authors.

  1. Research funding: None declared.

  2. Author contributions: All authors confirmed they have contributed to the intellectual content of this paper and have met the following 4 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; (c) final approval of the published article; and (d) agreement to be accountable for all aspects of the article thus ensuring that questions related to the accuracy or integrity of any part of the article are appropriately investigated and resolved. SF and DB, were involved in the provision of study material and conceptualization; MB, EV, FP, RR, FC, FB, MM, GM, AG were involved in the provision of study material; EB, MP, PK, CC, GZ revised and corrected the final draft. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: The Review Board of our institution approved the study, carried out according to the Helsinki Declaration of 1975, as revised in 1996.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2023-0008).

Received: 2023-01-04
Accepted: 2023-01-19
Published Online: 2023-01-27
Published in Print: 2023-06-27

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2023-0008
Schlagwörter für diesen Artikel
high grade; nomogram; risk; risk-benefit ratio; rule-in

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. ChatGPT: Angel or Demond? Critical thinking is still needed
  4. Mini Review
  5. Diagnostic accuracy of Siemens SARS-CoV-2 Antigen (CoV2Ag) chemiluminescent immunoassay for diagnosing acute SARS-CoV-2 infection: a pooled analysis
  6. Opinion Papers
  7. Neurofilament light chain as neuronal injury marker – what is needed to facilitate implementation in clinical laboratory practice?
  8. Clinical evidence requirements according to the IVDR 2017/746: practical tools and references for underpinning clinical evidence of IVD-MDs
  9. EFLM Papers
  10. Potentials and pitfalls of ChatGPT and natural-language artificial intelligence models for the understanding of laboratory medicine test results. An assessment by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group on Artificial Intelligence (WG-AI)
  11. Detection of antinuclear antibodies: recommendations from EFLM, EASI and ICAP
  12. Analytical aspects of the antinuclear antibody test by HEp-2 indirect immunofluorescence: EFLM report on an international survey
  13. Guidelines and Recommendations
  14. Variability of cardiac troponin levels in normal subjects and in patients with cardiovascular diseases: analytical considerations and clinical relevance
  15. General Clinical Chemistry and Laboratory Medicine
  16. Pre-analytical long-term stability of neopterin and neurofilament light in stored cerebrospinal fluid samples
  17. Development of a candidate reference measurement procedure by ID-LC-MS/MS for total tau protein measurement in cerebrospinal fluid (CSF)
  18. Assessing the commutability of candidate reference materials for the harmonization of neurofilament light measurements in blood
  19. Surface plasmon resonance assays for the therapeutic drug monitoring of infliximab indicate clinical relevance of anti-infliximab antibody binding properties
  20. An antibody-free LC-MS/MS method for the quantification of sex hormone binding globulin in human serum and plasma
  21. Accurate stratification between VEXAS syndrome and differential diagnoses by deep learning analysis of peripheral blood smears
  22. Establishing quality indicators for point of care glucose testing: recommendations from the Canadian Society for Clinical Chemists Point of Care Testing and Quality Indicators Special Interest Groups
  23. Clinical implication by differential analytical performances of serum free light chain quantitation analysis using fully automated analyzers
  24. Simultaneous analysis of antihyperglycemic small molecule drugs and peptide drugs by means of dual liquid chromatography high-resolution mass spectrometry
  25. Reference Values and Biological Variations
  26. Reference intervals for thyroid biomarkers to enhance the assessment of thyroid status in childhood and adolescence
  27. Biological variation of CA 15-3, CA 125 and HE 4 on lithium heparinate plasma in apparently healthy Caucasian volunteers
  28. Cancer Diagnostics
  29. Individual risk prediction of high grade prostate cancer based on the combination between total prostate-specific antigen (PSA) and free to total PSA ratio
  30. Cardiovascular Diseases
  31. Using logistic regression models to investigate the effects of high-sensitivity cardiac troponin T confounders on ruling in acute myocardial infarction
  32. Infectious Diseases
  33. Assessment of humoral and cellular immunity after bivalent BNT162b2 vaccination and potential association with reactogenicity
  34. Three rounds of a national external quality assessment reveal a link between disharmonic anti-SARS-CoV-2 antibody quantifications and the infection stage
  35. Corrigendum
  36. Where is laboratory medicine headed in the next decade? Partnership model for efficient integration and adoption of artificial intelligence into medical laboratories
  37. Letters to the Editor
  38. Please do not call it Theranos
  39. Lot-to-lot bias for high-sensitivity cardiac troponin I concentrations ≥1000 ng/L
  40. Lot-to-lot reagent changes and commutability of quality testing materials for total bile acid measurements
  41. On the importance of sampling interval in studies of biological variation in thyroid function
  42. Stability of plasma renin concentration based on plasma freezing time, as an adjunct to the stability data reported in the paper by Hepburn and others
  43. Falsely low beta-hCG results in pregnant woman on Siemens Atellica: don’t forget the “hook effect”
  44. Proenkephalin A 119–159 (penKid) – a novel biomarker and its quantification on the Nexus IB10 POC system for assessing kidney function
  45. Investigating the polyuria-polydipsia syndrome: the “PP” Shiny app
  46. Evaluation of a novel, stand-alone system to measure interleukin-6
  47. Spurious low WBC count in the WNR channel of Sysmex XN-9000 hematology analyzer in a case with leukocyte aggregation
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