Performance of 4Kscore as a reflex test to prostate-specific antigen in the GÖTEBORG-2 prostate cancer screening trial Journal Article
| Authors: | Josefsson, A.; Månsson, M.; Kohestani, K.; Spyratou, V.; Wallström, J.; Hellström, M.; Lilja, H.; Vickers, A.; Carlsson, S. V.; Godtman, R.; Hugosson, J. |
| Article Title: | Performance of 4Kscore as a reflex test to prostate-specific antigen in the GÖTEBORG-2 prostate cancer screening trial |
| 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% (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. © 2024 The Author(s) |
| Keywords: | adult; controlled study; human tissue; aged; middle aged; major clinical study; nuclear magnetic resonance imaging; magnetic resonance imaging; cancer diagnosis; cancer grading; sensitivity and specificity; prostate specific antigen; cancer screening; algorithms; high risk patient; risk assessment; prostate cancer; prostate-specific antigen; prostatic neoplasms; blood; algorithm; screening; prostate tumor; diagnosis; prostate biopsy; kallikrein; predictive value of tests; delayed diagnosis; informed consent; early detection of cancer; kallikreins; predictive value; avoidance behavior; diagnostic test accuracy study; procedures; neoplasm grading; humans; human; male; article; 4kscore; early cancer diagnosis; prostate imaging reporting and data system; goteborg-2 study |
| Journal Title: | European Urology |
| Volume: | 86 |
| Issue: | 3 |
| ISSN: | 0302-2838 |
| Publisher: | Elsevier Science, Inc. |
| Date Published: | 2024-09-01 |
| Start Page: | 223 |
| End Page: | 229 |
| Language: | English |
| DOI: | 10.1016/j.eururo.2024.04.037 |
| PUBMED: | 38772787 |
| PROVIDER: | scopus |
| PMCID: | PMC11747930 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PubMed record and PDF -- Source: Scopus |
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