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Eur Urol. 2015 Sep;68(3):464-70. doi: 10.1016/j.eururo.2014.10.021. Epub 2014 Oct 27.

A multi-institutional prospective trial in the USA confirms that the 4Kscore accurately identifies men with high-grade prostate cancer.

Author information

1
Department of Urology, University of Miami Miller School of Medicine and Sylvestor Comprehensive Cancer Center, Miami, FL, USA. Electronic address: parekhd@med.miami.edu.
2
Department of Urology, University of Miami Miller School of Medicine and Sylvestor Comprehensive Cancer Center, Miami, FL, USA.
3
Department of Urology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
4
Delaware Valley Urology, Mt Laurel, NJ, USA.
5
First Urology, Jeffersonville, IN, USA.
6
Urology Clinics of North Texas, Dallas, TX, USA.
7
Urology Associates, Nashville, TN, USA.
8
Skyline Urology, Sherman Oaks, CA, USA.
9
Alliance Research Centers, Laguna Hills, CA, USA.
10
The Urology Group, Cincinnati, OH, USA.
11
Central Ohio Urology Group, Columbus, OH, USA.
12
Atlantic Urological Associates, Daytona, FL, USA.
13
Regional Urology, Shreveport, LA, USA.
14
The Urology Center of Colorado, Denver, CO, USA.
15
Delaware Valley Urology, Voorhees, NJ, USA.
16
Arkansas Urology, Little Rock, AR, USA.
17
University of Washington, Seattle, WA, USA.
18
Adult and Pediatric Urology, Sarteli, MN, USA.
19
Manchester Urology, Manchester, NH, USA.
20
Associated Medical Professionals of NY, Syracuse, NY, USA.
21
Lahey Hospital and Medical Center, Burlington, MA, USA.
22
Urology San Antonio, San Antonio, TX, USA.
23
Urology of Indiana, Greenwood, IN, USA.
24
Atlantic Urology Clinics, Myrtle Beach, SC, USA.
25
Lancaster Urology, Lancaster, PA, USA.
26
Idaho Urologic Institute, Meridian, ID, USA.
27
Skyline Urology, Torrance, CA, USA.
28
Andover Urology, Andover, MA, USA.

Abstract

BACKGROUND:

The 4Kscore combines measurement of four kallikreins in blood with clinical information as a measure of the probability of significant (Gleason ≥7) prostate cancer (PCa) before prostate biopsy.

OBJECTIVE:

To perform the first prospective evaluation of the 4Kscore in predicting Gleason ≥7 PCa in the USA.

DESIGN, SETTING, AND PARTICIPANTS:

Prospective enrollment of 1012 men scheduled for prostate biopsy, regardless of prostate-specific antigen level or clinical findings, was conducted at 26 US urology centers between October 2013 and April 2014.

INTERVENTION:

The 4Kscore.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:

The primary outcome was Gleason ≥7 PCa on prostate biopsy. The area under the receiver operating characteristic curve, risk calibration, and decision curve analysis (DCA) were determined, along with comparisons of probability cutoffs for reducing the number of biopsies and their impact on delaying diagnosis.

RESULTS AND LIMITATIONS:

Gleason ≥7 PCa was found in 231 (23%) of the 1012 patients. The 4Kscore showed excellent calibration and demonstrated higher discrimination (AUC 0.82) and net benefit compared to a modified Prostate Cancer Prevention Trial Risk Calculator 2.0 model and standard of care (biopsy for all men) according to DCA. A possible reduction of 30-58% in the number biopsies was identified with delayed diagnosis in only 1.3-4.7% of Gleason ≥7 PCa cases, depending on the threshold used for biopsy. Pathological assessment was performed according to the standard of care at each site without centralized review.

CONCLUSION:

The 4Kscore showed excellent diagnostic performance in detecting significant PCa. It is a useful tool in selecting men who have significant disease and are most likely to benefit from a prostate biopsy from men with no cancer or indolent cancer.

PATIENT SUMMARY:

The 4Kscore provides each patient with an accurate and personalized measure of the risk of Gleason ≥7 cancer to aid in decision-making regarding the need for prostate biopsy.

KEYWORDS:

Biomarkers; Biopsy; Prostate cancer; Screening

PMID:
25454615
DOI:
10.1016/j.eururo.2014.10.021
[Indexed for MEDLINE]

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