The electromagnetic detection of prostatic cancer: evaluation of diagnostic accuracy.

OBJECTIVES

To evaluate the accuracy of the TRIMprob in the diagnosis of prostate neoplasm.

METHODS

Consecutive patients referred for prostate biopsy were prospectively enrolled. Patients had history taken, physical examination by digital rectal examination (DRE) of the prostate, assessment of total and free serum prostate-specific antigen (PSA) levels, prostate transrectal ultrasonography (TRUS), and TRIMprob test. Indications for prostate biopsy included one or more of the following conditions: total serum PSA levels of 4.0 ng/mL or more, free/total serum PSA ratio of 0.18 or less, positive results on DRE, and suspicious findings on TRUS. Twelve-core, TRUS-guided biopsies were performed with local anesthesia. A blinded investigator performed the TRIMprob test; the lowest value of the signal at 465 MHz was looked for and recorded, although data of the electromagnetic signal at 930 and 1295 MHz were also recorded.

RESULTS

One hundred eleven patients (aged 64.9 +/- 8.1 years, mean +/- standard deviation), enrolled between November 2004 and August 2005, were analyzed. Total serum PSA level was 8.4 +/- 3.6 ng/mL, and free/total serum PSA ratio was 0.15 +/- 0.7. TRIMprob sensitivity for the diagnosis of prostate cancer was 0.86%; specificity and positive and negative predictive values were 0.60 and 0.88; accuracy was 72%. TRIMprob accuracy outperformed any other diagnostic parameter considered, including the rule of chance. The association of TRIMprob and DRE offered a sensitivity and a negative predictive value of 0.86% or greater.

CONCLUSIONS

TRIMprob had the highest accuracy rate, among all other tests, for the diagnosis of prostate cancer. Electromagnetic detection with the TRIMprob test seems to be a promising technology and a useful additional tool for the early detection of prostate cancer.