AroCell TK 210 ELISA may complement pro PSA and the prostate health index in differentiating non-cancerous from cancerous conditions in prostate disease


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Kiran Kumar Jagalamudi1,Staffan Eriksson2,Mojca Zupan3,Kristina Kumer4,Teja Fabjan4,Goran Hlebič5,Tomaž Smrkolj5,Joško Osredkar4
1AroCell AB. www.arocell.com,2Swedish Agricultural University,3Blood Transfusion Unit, Ljubljana,4Institute of Clinical Biochemistry, Ljubljana,5University Medical Centre, Ljubljana

Abstract

Background

The AroCell TK 210 ELISA kit is a novel method for determining the proliferation biomarker Thymidine Kinase 1 (TK1).

Pro PSA, free PSA and the prostate health index (PHI) have been proposed as more discriminating tests than PSA in distinguishing between benign and cancerous prostate changes. The purpose of this study was to compare the AroCell TK 210 ELISA with PSA, free PSA, pro PSA and PHI in men with non-cancerous conditions or confirmed prostate cancer.

Method

Serum samples from 94 subjects undergoing investigation for prostate cancer with PSA values in the range 2 to 10 µg/L were collected at the University Medical Centre, Ljubljana. 70% had non-cancerous conditions, while 30% had confirmed cancer (PCa). TK1 protein levels were determined using AroCell TK 210 ELISA. PSA, fPSA and pro PSA levels were analysed with commercial assays.

Results

17% of patients had serum TK1 protein levels above the estimated cut-off value for age-matched healthy men (0.45µg/L). 11% of the non-cancerous group had TK1 protein levels above the cut-off, compared with 31% in the prostate cancer group. TK1 protein values in the PCa group (mean=0.41µg/L) differed significantly from those with non-cancerous conditions (mean=0.31µg/L, P=0.01). Pro PSA and PHI also differentiated the prostate cancer group from those with non-cancerous conditions (P= 0.01 and P<0.001, respectively). fPSA and PSA did not. AroCell TK 210 ELISA showed significant correlation with PHI (r=0.32, P=0.0017) and pro PSA (r=0.21 P=0.044) but not with fPSA or PSA.

Conclusion

Serum TK1 assayed with the AroCell TK 210 ELISA kit can differentiate between non-cancerous and prostate cancer patients with a similar accuracy to that of pro PSA.

 

Further clinical studies will establish the capacity of the AroCell TK 210 ELISA kit to complement pro PSA and PHI in distinguishing between non-cancerous and prostate cancer, potentially providing another tool in prostate cancer management.