Objectives
To compare both the concordance between the 4Kscore and SelectMDx for informing decision
to perform prostate biopsy (PB) and the performance of these tests for detecting clinically
significant prostate cancer (csPCa). Several biomarkers were developed to inform decisions
whether to perform a PB based on the probability of detecting csPCa. There is a paucity
of studies directly comparing them
Methods
Between 11/2018 and 4/2019, all new referrals with the diagnosis of elevated PSA were
advised to undergo 4Kscore and SelectMDx in order to guide the selection of candidates
for PB. Men were advised to undergo PB if the reported biomarker risk for detecting
csPCA was ≥7.5%, or if they presented a Prostate Image Reporting and Data System ≥1
MRI. Cohen's Kappa was used to assess the concordance between the binary 4Kscore and
SelectMDx results using externally validated cutoffs of 7.5% and 12%. Receiver operating
characteristics curve and area under the curve (AUC) assessed the performance of each
biomarker for distinguishing csPCa.
Results
Of 128 consecutive patients referred, 114 (89.1%) underwent 4Kscore and SelectMDx.
The kappa coefficient between the biomarkers using the 7.5% cutoff was 0.184 (poor
concordance) and 0.22 using the 12% cutoff. The two biomarkers yielded discordant
guidance whether to proceed with PB in 46% and 38% of cases, respectively. csPCa was
found in 22 of the 50 patients who underwent PB (44%). The AUC for 4Kscore and SelectMDx
was 0.830 (95% confidence interval [CI]: 0.710 - 0.949) and 0.672 (95%CI: 0.517 -
0.828; P = .036) for csPCa, respectively.
Conclusion
The discordance observed between the 4Kscore and SelectMDx is disconcerting. The 4Kscore
when combined with magnetic resonance imaging was superior to the SelectMDx for detecting
csPCa. Prospective comparative studies must be performed to optimize implementation
of biomarkers for selecting candidates for PB.
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Article info
Publication history
Published online: April 12, 2020
Accepted:
February 23,
2020
Received:
November 24,
2019
Footnotes
Declaration of interests: Dr Loeb is supported by the Prostate Cancer Foundation and The Edward Blank and Sharon Cosloy-Blank Family Foundation, and declares reimbursed travel from Sanofi, and equity in Gilead.
Identification
Copyright
© 2020 Elsevier Inc. All rights reserved.
