title: The 4Kscore® Test Reduces Prostate Biopsy Rates in Community and Academic Urology Practices.
abstract: There is significant concern regarding prostate cancer screening because of the potential for overdiagnosis and overtreatment of men who are discovered to have abnormal prostate specific antigen (PSA) levels and/or digital rectal examination (DRE) results. The 4Kscore® Test (OPKO Diagnostics, LLC) is a blood test that utilizes four kallikrein levels plus clinical information in an algorithm to calculate an individual's percentage risk (< 1% to > 95%) for aggressive prostate cancer (Gleason score ≥ 7) on prostate biopsy. The 4Kscore Test, as a follow-up test after abnormal PSA and/or DRE test results, has been shown to improve the specificity for predicting the risk of aggressive prostate cancer and reduce unnecessary prostate biopsies. A clinical utility study was conducted to assess the influence of the 4Kscore Test on the decision to perform prostate biopsies in men referred to urologists for abnormal PSA and/or DRE results. The study population included 611 patients seen by 35 academic and community urologists in the United States. Urologists ordered the 4Kscore Test as part of their assessment of men referred for abnormal PSA and/or DRE test results. Results for the patients were stratified into low risk (< 7.5%), intermediate risk (7.5%-19.9%), and high risk (≥ 20%) for aggressive prostate cancer. The 4Kscore Test results influenced biopsy decisions in 88.7% of the men. Performing the 4Kscore Test resulted in a 64.6% reduction in prostate biopsies in patients; the actual percentage of cases not proceeding to biopsy were 94.0%, 52.9%, and 19.0% for men who had low-, intermediate-, and high-risk 4Kscore Test results, respectively. A higher 4Kscore Test was associated with greater likelihood of having a prostate biopsy (P < 0.001). Among the 171 patients who had a biopsy, the 4Kscore risk category is strongly associated with biopsy pathology. The 4Kscore Test, as a follow-up test for an abnormal PSA and/or DRE results, significantly influenced the physician and patient shared decision in clinical practice, which led to a reduction in prostate biopsies while increasing the probability of detecting aggressive cancer.
authors.affiliation: Department of Urology, University of Minnesota, Minneapolis, MN.
authors.forename: Badrinath
authors.initials: B
authors.lastname: Konety
authors.affiliation: Department of Urology, Tufts University School of Medicine, Boston, MA.
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Zappala
authors.affiliation: Department of Urology, University of Miami Miller School of Medicine, Miami, FL.
authors.forename: Dipen J
authors.initials: DJ
authors.lastname: Parekh
authors.affiliation: Michigan Institute of Urology, St. Clair Shores, MI.
authors.forename: Danielle
authors.initials: D
authors.lastname: Osterhout
authors.affiliation: Michigan Institute of Urology, St. Clair Shores, MI.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Schock
authors.affiliation: Michigan Institute of Urology, St. Clair Shores, MI.
authors.forename: Randy M
authors.initials: RM
authors.lastname: Chudler
authors.affiliation: Michigan Institute of Urology, St. Clair Shores, MI.
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Oldford
authors.affiliation: Michigan Institute of Urology, St. Clair Shores, MI.
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Kernen
authors.affiliation: Michigan Institute of Urology, St. Clair Shores, MI.
authors.forename: Jason
authors.initials: J
authors.lastname: Hafron
keywords: 4Kscore Test; Biopsy rate; Digital rectal examination; Gleason score; Prostate cancer; Prostate cancer prognosis; Prostate-specific antigen
references.citation: J Natl Compr Canc Netw. 2015 Dec;13(12 ):1534-61
references.pmid: 26656522
references.citation: BMC Med. 2008 Jul 08;6:19
references.pmid: 18611265
references.citation: Cancer Causes Control. 2008 Mar;19(2):175-81
references.pmid: 18027095
references.citation: Cancer. 2010 Jun 1;116(11):2612-20
references.pmid: 20336781
references.citation: J Clin Oncol. 2012 Feb 10;30(5):513-8
references.pmid: 22215756
references.citation: Eur Urol. 2012 Dec;62(6):976-83
references.pmid: 22698574
references.citation: Br J Cancer. 2010 Aug 24;103(5):708-14
references.pmid: 20664589
references.citation: BJU Int. 2016 Jun;117(6B):E10-9
references.pmid: 25818406
references.citation: J Clin Oncol. 2010 May 20;28(15):2493-8
references.pmid: 20421547
references.citation: N Engl J Med. 2013 Jan 31;368(5):436-45
references.pmid: 23363497
references.citation: BMC Cancer. 2010 Nov 22;10:635
references.pmid: 21092177
references.citation: JAMA. 2015 Nov 17;314(19):2031-3
references.pmid: 26575059
references.citation: Ann Intern Med. 2012 Jul 17;157(2):120-34
references.pmid: 22801674
references.citation: J Urol. 2013 Jan;189(1 Suppl):S12-7; discussion S17-8
references.pmid: 23234616
references.citation: J Natl Cancer Inst. 2015 Apr 11;107(7):null
references.pmid: 25863334
references.citation: Eur Urol. 2015 Sep;68(3):464-70
references.pmid: 25454615
references.citation: J Urol. 2015 May;193(5):1519-24
references.pmid: 25481037
references.citation: JAMA. 2015 Nov 17;314(19):2054-61
references.pmid: 26575061
references.citation: N Engl J Med. 2013 Apr 25;368(17):1654
references.pmid: 23614595
references.citation: Clin Cancer Res. 2010 Jun 15;16(12):3232-9
references.pmid: 20400522
references.citation: J Natl Cancer Inst. 2012 Jan 18;104(2):125-32
references.pmid: 22228146
references.citation: J Urol. 2015 Sep;194(3):626-34
references.pmid: 25849602
references.citation: CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29
references.pmid: 24399786
references.citation: Curr Opin Urol. 2013 Jul;23(4):331-6
references.pmid: 23619582
references.citation: N Engl J Med. 2009 Mar 26;360(13):1320-8
references.pmid: 19297566
references.citation: Eur Urol. 2015 Oct;68(4):600-8
references.pmid: 25242555
references.citation: Eur Urol. 2015 Aug;68(2):207-13
references.pmid: 25682340
references.citation: Eur Urol. 2015 Mar;67(3):451-7
references.pmid: 24746973