Tissue-resonance interaction method for the noninvasive diagnosis of prostate cancer: analysis of a multicentre clinical evaluation.

OBJECTIVE: To determine, in a multicentre prospective study, the accuracy of the tissue-resonance interaction method (TRIMprob, new technology developed for the noninvasive analysis of electromagnetic anisotropy in biological tissues) in the diagnosis of prostate cancer. PATIENTS AND METHODS: Two hundred patients (mean age 67.4 years) scheduled to have prostatic biopsies (because of a prostate-specific, PSA, antigen level of >/=4 ng/mL or a suspicious digital rectal examination, DRE) were preliminarily examined while unaware of their clinical details using TRIMprob in five different centres. The final diagnosis obtained with TRIMprob was compared with the final histological diagnosis after extended biopsies. RESULTS: Of the 188 evaluable patients (mean PSA level 9.3 ng/mL, sd 8.8; mean prostate volume 62.0 mL, sd 32.4), 61 (32.4%) had a positive biopsy for adenocarcinoma of the prostate. The overall sensitivity, specificity, positive predictive value, negative predictive value (NPV) and accuracy of TRIMprob were 80%, 51%, 44%, 84% and 60%, respectively. The prostate cancer detection rate after biopsy was significantly higher in patients with a positive examination (49/111, 44%) than in patients with a negative TRIMprob (12/77, 15%; P < 0.001). When TRIMprob results were combined with DRE findings the sensitivity and NPV both increased to 92%. CONCLUSION: TRIMprob seems to be a useful tool in the diagnosis of prostate cancer and can increase the accuracy of PSA or DRE results. The high NPV suggests that this new technology might be useful to reduce the indications for prostatic biopsy or repeated series of biopsies in patients suspected of having prostate cancer.