Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 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

Dipen J Parekh  1 , Sanoj Punnen  2 , Daniel D Sjoberg  3 , Scott W Asroff  4 , James L Bailen  5 , James S Cochran  6 , Raoul Concepcion  7 , Richard D David  8 , Kenneth B Deck  9 , Igor Dumbadze  10 , Michael Gambla  11 , Michael S Grable  12 , Ralph J Henderson  13 , Lawrence Karsh  14 , Evan B Krisch  15 , Timothy D Langford  16 , Daniel W Lin  17 , Shawn M McGee  18 , John J Munoz  19 , Christopher M Pieczonka  20 , Kimberley Rieger-Christ  21 , Daniel R Saltzstein  22 , John W Scott  23 , Neal D Shore  24 , Paul R Sieber  25 , Todd M Waldmann  26 , Fredrick N Wolk  27 , Stephen M Zappala  28
Affiliations
Multicenter Study

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

Dipen J Parekh et al. Eur Urol. 2015 Sep.

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.

PubMed Disclaimer

Publication types