Journal
EUROPEAN UROLOGY
Volume 68, Issue 1, Pages 139-146Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.eururo.2014.08.010
Keywords
Prostatic neoplasms; Biomarkers; Prostate-specific antigen; Kallikrein-related peptidases
Categories
Funding
- Strategic Research Programme on Cancer (StratCan), Karolinska Institutet
- Linne Centre for Breast and Prostate Cancer (CRISP), Karolinska Institutet [70867901]
- Swedish Research Council [K2010-70X-20430-04-3]
- Swedish Cancer Society [11-0287, 11-0624]
- Stiftelsen Johanna Hagstrand och Sigfrid Linners minne
- Swedish Council for Working Life and Social Research (FAS) [2012-0073]
- National Cancer Institute [R33CA127768-03, R01CA160816, P50-CA92629]
- Sidney Kimmel Center for Prostate and Urologic Cancers
- David H. Koch through the Prostate Cancer Foundation
- National Institute for Health Research (NIHR) Oxford Biomedical Research Centre Program
- Fundacion Federico SA
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Background: The four-kallikrein panel and the Prostate Health Index (PHI) have been shown to improve prediction of prostate cancer (PCa) compared with prostate-specific antigen (PSA). No comparison of the four-kallikrein panel and PHI has been presented. Objective: To compare the four-kallikrein panel and PHI for predicting PCa in an independent cohort. Design, setting, and participants: Participants were from a population-based cohort of PSA-tested men in Stockholm County. We included 531 men with PSA levels between 3 and 15 ng/ml undergoing first-time prostate biopsy during 2010-2012. Outcome measurements and statistical analysis: Models were fitted to case status. We computed calibration curves, the area under the receiver-operating characteristics curve (AUC), decision curves, and percentage of saved biopsies. Results and limitations: The four-kallikrein panel showed AUCs of 69.0 when predicting any-grade PCa and 71.8 when predicting high-grade cancer (Gleason score >= 7). Similar values were found for PHI: 70.4 and 71.1, respectively. Both models had higher AUCs than a base model with PSA value and age (p < 0.0001 for both); differences between models were not significant. Sensitivity analyses including men with any PSA level or a previous biopsy did not materially affect our findings. Using 10% predicted risk of high-grade PCa by the four-kallikrein panel or PHI of 39 as cut-off for biopsy saved 29% of performed biopsies at a cost of delayed diagnosis for 10% of the men with high-grade cancers. Both models showed limited net benefit in decision analysis. The main study limitation was lack of digital rectal examination data and biopsy decision being based on PSA information. Conclusions: The four-kallikrein panel and PHI similarly improved discrimination when predicting PCa and high-grade PCa. Both are simple blood tests that can reduce the number of unnecessary biopsies compared with screening with total PSA, representing an important new option to reduce harm. Patient summary: Prostate-specific antigen screening is controversial due to limitations of the test. We found that two blood tests, the Prostate Health Index and the four-kallikrein panel, performed similarly and could both aid in decision making among Swedish men undergoing a prostate biopsy. (C) 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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