Abstract
BackgroundA pre-specified model based on four kallikrein markers in blood, commercially available as 4Kscore, predicts Gleason Grade (GG) 3 + 4 or higher prostate cancer on biopsy. However, sampling error and variation in pathology reporting may miss aggressive disease.MethodsThe 4Kscore was measured in cryopreserved blood from 2330 men obtained before prostatectomy at a single institution between 2002 and 2010. Adverse surgical pathology and biochemical recurrence (BCR) were pre-specified to be assessed in all men, biopsy GG 3 + 3, and 3 + 4.ResultsAdjusted for established clinical predictors, the 4Kscore was significantly associated with adverse pathology (OR 1.49; 95% CI 1.32, 1.67; p < 0.0001). Adding 4Kscore increased discrimination from (AUC) 0.672 to 0.718 and 0.644 to 0.659 within biopsy GG 3 + 3 and 3 + 4, respectively. Higher 4Kscore was associated with higher risk of BCR (HR 1.16, 95% CI 1.06, 1.26; p = 0.001). Adding 4Kscore improved the prediction of BCR (C-index 0.630–0.660) within GG 3 + 3, but not GG 3 + 4.ConclusionsThe 4Kscore can help guide the clinical decision whether additional risk assessment—such as confirmatory biopsy—is needed to decide between active surveillance versus curative therapy. Evidence that the panel could influence management in biopsy GG 3 + 4 is less strong and requires further investigation.
Highlights
A pre-specified model based on four kallikrein markers in blood, commercially available as 4Kscore, predicts Gleason Grade (GG) 3 + 4 or higher prostate cancer on biopsy
Our objective was to assess the ability of the 4Kscore to predict adverse pathology at prostatectomy—the gold standard for accurate histological diagnosis—and biochemical recurrence (BCR), with a focus on men diagnosed with Gleason 3 + 3 or 3 + 4 prostate cancer at biopsy
4Kscore was significantly associated with adverse pathology, after adjusting for clinical variables
Summary
A pre-specified model based on four kallikrein markers in blood, commercially available as 4Kscore, predicts Gleason Grade (GG) 3 + 4 or higher prostate cancer on biopsy. Adverse surgical pathology and biochemical recurrence (BCR) were pre-specified to be assessed in all men, biopsy GG 3 + 3, and 3 + 4. CONCLUSIONS: The 4Kscore can help guide the clinical decision whether additional risk assessment—such as confirmatory biopsy —is needed to decide between active surveillance versus curative therapy. With its low specificity, most men with moderately elevated PSA do not have aggressive prostate cancer.[1] Prostate biopsy is an invasive and uncomfortable diagnostic procedure associated with non-trivial risks of complications, including rectal haemorrhage, urinary tract infection, sepsis and hospitalisation.[2,3] the use of liberal criteria for biopsy are associated with the risk of identifying low-grade prostate cancer, which leads to the expense, inconvenience and anxiety of active surveillance, but often leads to overtreatment. If low-to-intermediate-risk cancer (Gleason 3 + 3 and 3 + 4) is found on biopsy, the urologist faces challenging clinical decisions: (i) for those with Gleason 3 + 3, whether or not to perform a confirmatory biopsy or other risk assessment before recommending active surveillance,[4,5] and (ii) for those with Gleason 3 + 4, whether or not to recommend curative treatment—surgery or radiation
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
