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Performance of 4Kscore as a Reflex Test to Prostate-specific Antigen in the GÖTEBORG-2 Prostate Cancer Screening Trial

Josefsson, Andreas ; Månsson, Marianne ; Kohestani, Kimia ; Spyratou, Vasiliki ; Wallström, Jonas ; Hellström, Mikael ; Lilja, Hans LU orcid ; Vickers, Andrew ; Carlsson, Sigrid V. LU and Godtman, Rebecka , et al. (2024) In European Urology
Abstract

Background and objective: We investigated whether adding 4Kscore as a reflex test to prostate-specific antigen (PSA) could improve the screening algorithm for prostate cancer (PC). Methods: In the GÖTEBORG-2 PC screening trial, 38 000men (50–60 yr) were invited to PSA testing and, if elevated, followed by magnetic resonance imaging (MRI). For 571 men with PSA ≥3.0 ng/ml and evaluable outcomes, 4Kscore was calculated. The performance using a prespecified 4Kscore cutoff of 7.5% was evaluated. Key findings and limitations: The area under the curve for 4Kscore to identify intermediate- and high-risk PC was 0.84 (95% confidence interval 0.79–0.89), and the positive predictive value, and negative predictive value were 15% (0.12–0.20) and 99%... (More)

Background and objective: We investigated whether adding 4Kscore as a reflex test to prostate-specific antigen (PSA) could improve the screening algorithm for prostate cancer (PC). Methods: In the GÖTEBORG-2 PC screening trial, 38 000men (50–60 yr) were invited to PSA testing and, if elevated, followed by magnetic resonance imaging (MRI). For 571 men with PSA ≥3.0 ng/ml and evaluable outcomes, 4Kscore was calculated. The performance using a prespecified 4Kscore cutoff of 7.5% was evaluated. Key findings and limitations: The area under the curve for 4Kscore to identify intermediate- and high-risk PC was 0.84 (95% confidence interval 0.79–0.89), and the positive predictive value, and negative predictive value were 15% (0.12–0.20) and 99% (97–100%), respectively. Of the 54 men diagnosed with intermediate- or high-grade PC, two had a 4Kscore cutoff below 7.5%, both with organ-confined intermediate-risk PC. Per 1000 men with elevated PSA, adding 4Kscore would have resulted in avoidance of MRI for 408 (41%) men, biopsies for 95 (28% reduction) men, and diagnosis of 23 low-grade cancers (23% reduction) while delaying the diagnosis of four men with intermediate-grade cancers (4%). Conclusions and clinical implications: Including 4Kscore as a reflex test for men with elevated PSA reduces the need for MRI and biopsy markedly, and results in less overdiagnosis of low-grade PC at the cost of delaying the diagnosis of intermediate-grade PC in a few men. These results add further evidence for including new blood-based biomarkers in addition to PSA to improve the harm and benefit ratio of PC screening and reduce the need for resource-demanding MRI and biopsies. Patient summary: In this study, 4Kscore, a blood-based biomarker, as a reflex test for men with elevated prostate-specific antigen (PSA), reduces the need for magnetic resonance imaging and biopsy. These results support the inclusion of new blood-based biomarkers in addition to PSA.

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organization
publishing date
type
Contribution to journal
publication status
epub
subject
keywords
4Kscore, GOTEBORG-2 study, Magnetic resonance imaging, Prostate cancer, Prostate-specific antigen, Screening
in
European Urology
publisher
Elsevier
external identifiers
  • pmid:38772787
  • scopus:85193619279
ISSN
0302-2838
DOI
10.1016/j.eururo.2024.04.037
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2024 The Author(s)
id
323a66e7-f6de-4a45-967e-e34378a9f3b1
date added to LUP
2024-05-27 08:32:58
date last changed
2024-06-24 11:23:34
@article{323a66e7-f6de-4a45-967e-e34378a9f3b1,
  abstract     = {{<p>Background and objective: We investigated whether adding 4Kscore as a reflex test to prostate-specific antigen (PSA) could improve the screening algorithm for prostate cancer (PC). Methods: In the GÖTEBORG-2 PC screening trial, 38 000men (50–60 yr) were invited to PSA testing and, if elevated, followed by magnetic resonance imaging (MRI). For 571 men with PSA ≥3.0 ng/ml and evaluable outcomes, 4Kscore was calculated. The performance using a prespecified 4Kscore cutoff of 7.5% was evaluated. Key findings and limitations: The area under the curve for 4Kscore to identify intermediate- and high-risk PC was 0.84 (95% confidence interval 0.79–0.89), and the positive predictive value, and negative predictive value were 15% (0.12–0.20) and 99% (97–100%), respectively. Of the 54 men diagnosed with intermediate- or high-grade PC, two had a 4Kscore cutoff below 7.5%, both with organ-confined intermediate-risk PC. Per 1000 men with elevated PSA, adding 4Kscore would have resulted in avoidance of MRI for 408 (41%) men, biopsies for 95 (28% reduction) men, and diagnosis of 23 low-grade cancers (23% reduction) while delaying the diagnosis of four men with intermediate-grade cancers (4%). Conclusions and clinical implications: Including 4Kscore as a reflex test for men with elevated PSA reduces the need for MRI and biopsy markedly, and results in less overdiagnosis of low-grade PC at the cost of delaying the diagnosis of intermediate-grade PC in a few men. These results add further evidence for including new blood-based biomarkers in addition to PSA to improve the harm and benefit ratio of PC screening and reduce the need for resource-demanding MRI and biopsies. Patient summary: In this study, 4Kscore, a blood-based biomarker, as a reflex test for men with elevated prostate-specific antigen (PSA), reduces the need for magnetic resonance imaging and biopsy. These results support the inclusion of new blood-based biomarkers in addition to PSA.</p>}},
  author       = {{Josefsson, Andreas and Månsson, Marianne and Kohestani, Kimia and Spyratou, Vasiliki and Wallström, Jonas and Hellström, Mikael and Lilja, Hans and Vickers, Andrew and Carlsson, Sigrid V. and Godtman, Rebecka and Hugosson, Jonas}},
  issn         = {{0302-2838}},
  keywords     = {{4Kscore; GOTEBORG-2 study; Magnetic resonance imaging; Prostate cancer; Prostate-specific antigen; Screening}},
  language     = {{eng}},
  publisher    = {{Elsevier}},
  series       = {{European Urology}},
  title        = {{Performance of 4Kscore as a Reflex Test to Prostate-specific Antigen in the GÖTEBORG-2 Prostate Cancer Screening Trial}},
  url          = {{http://dx.doi.org/10.1016/j.eururo.2024.04.037}},
  doi          = {{10.1016/j.eururo.2024.04.037}},
  year         = {{2024}},
}