Evaluation of PCR-ELISA for determination of telomerase activity in prostate needle biopsy and prostatic fluid specimens.

The conventional TRAP assay will determine telomerase activity in tissue or other specimens. However, methodological disadvantages limit its clinical use. We evaluated a modified TRAP assay, the telomerase PCR-ELISA, as a practical clinical system for measuring its activity in conjunction with prostate cancer (PCa). We examined telomerase activity by both TRAP and PCR-ELISA assays in 48 sextant needle biopsy (SNB) specimens from dye-marked areas of the prostate glands of 7 PCa patients. Each specimen was histologically confirmed as cancerous or cancer-free by examining a paired specimen taken from the same marked area. In addition, prostatic fluid (PF) specimens were analyzed from 18 patients, 9 of whom were diagnosed with PCa while 9 were diagnosed as cancer-free but mostly with BPH. The results on individual SNB specimens matched well for the two methods. The sensitivity (91%) and specificity (69%) for the PCR-ELISA measurements were consistent with those for the conventional TRAP assay, 88% and 81%, respectively. Quantitatively, with the PCR-ELISA assay, the mean telomerase activity (24.5+/-28.4 units) per needle core with PCa cells was significantly higher than that in needle cores without PCa cells (7.2+/-2.2 unit), as it was with the conventional TRAP assay, namely 25.6+/-27.8 units and 7.3+/-1.8 units, respectively. In PF specimens from PCa patients, which had a lower mean telomerase than was found in needle cores containing PCa cells (7.1+/-1.5 units in the PCR-ELISA, 7.2+/-1.8 units in the conventional TRAP assay), statistical analysis showed good matching between the results from the two assays, overall. In conclusion, the PCR-ELISA can be considered a reliable method to determine telomerase activity as an adjunct in the diagnosis and treatment of prostate cancer.