Potential usefulness of CTC detection in follow up of prostate cancer patients. A preliminary report obtained by using Adnagene platform

Objective: Prostate cancer (PCa) represents one of the most important medical problems for males, being the second major cause of cancer death. Routinely, PCa patients are followed up with both periodic evaluation of serum PSA levels and imaging. Recently, alternative laboratory methods were proposed for PCa patients' monitoring, with contrasting results. Aim of the present study was to evaluate the usefulness of a new commercially CE-IVD kit for detection of prostate circulating tumour cells. Our intention was to verify the Adnagene platform usefulness to identify patients with disease progression, whatever treatment ongoing, in order to modify the therapeutic process even before treatment failure is evident with imaging methods. Materials and Methods: Twenty-one patients were enrolled and subdivided into three groups: n = 10 high risk tumor PCa patients; n = 6 low risk PCa patients; n = 5 sbjects without any signs of PCa. AdnaTest Prostate Cancer kit was used for enrichment and molecular characterization of prostate circulating tumour cells. Results: Healthy subjects (with BPH) and patients without metastases resulted as negative, while 3 out of 10 high risk PCa patients were positive at least for one molecular marker like PSA, while only two showed positivity for PSMA mRNA. Our results indicate that the test specificity is 100% and the sensitivity is 100%; of course the sample is too small to give it statistical validity. In detail we verified that only the "not responder" patients resulted positive for AdnaTest. Conclusions: The present preliminary report provides evidence that isolation and detection of circulating tumour cells (CTCs) is feasible and it may be useful in the follow-up of patients with advanced prostate cancer. If the results of this preliminary study would be confirmed by a large prospective cohort study, it could be demonstrated that this test is a rapid diagnostic method, based on the analysis of a blood sample and useful to the clinician to decide when to change therapy for patients resistant to castration or able to confirm that, at that time, the therapy is effective.