Evaluation of the diagnostic value of three YiDiXie tests in prostate cancer: an observational prospective single-center study

Prostate-Specific Antigen (PSA) and Magnetic Resonance Imaging (MRI) are widely used in the diagnosis of prostate cancer (PCa), but relatively inaccurate results may affect diagnosis and treatment. There is an urgent need to find convenient, economical and non-invasive diagnostic methods to reduce the false positive and false negative rates of PSA or MRI. The purpose of this study was to evaluate the diagnostic value of YiDiXie-30, YiDiXie-32, and YiDiXie-48 in prostate cancer. This study ultimately included 562 participants (malignant group, n = 357; benign group, n = 205). Residual serum samples from the participants were collected and tested using the YiDiXie all-cancer detection kit to assess the sensitivity, specificity, positive likelihood ratio(PLR) and negative likelihood ratio(NLR) of YiDiXie-30, YiDiXie-32 and YiDiXie-48, respectively. Receiver-operating characteristic (ROC) curves’ analyses were included in this study. The sensitivity of YiDiXie-30 was 81.2%, with a specificity of 93.2%, positive likelihood ratio (PLR) of 11.9, and negative likelihood ratio (NLR) of 0.20. Corresponding values for YiDiXie-32 were 93.6%, 85.4%, 6.4, and 0.08, while those for YiDiXie-48 were 99.4%, 61.5%, 2.6, and 0.01, respectively. Further studies found that YiDiXie-30, YiDiXie-32, and YiDiXie-48 yielded similar results in patients with positive or negative PSA or MRI. The results of the single-center study showed that the YiDiXie tests were highly effective in diagnosing prostate cancer, with clearly different levels of sensitivity and specificity. The YiDiXie tests show strong diagnostic utility for prostate cancer within the particular clinical and population context of this study cohort, especially the YiDiXie-30 (extremely high PLR) and YiDiXie-48 ((extremely low NLR). This method has the potential to significantly reduce needless biopsies brought on by false-positive PSA or MRI results. The two main issues of “excessively high false-positive rates” and “excessively high false-negative rates” in PSA or MRI are anticipated to be addressed. Clinical Research Registry Number: ChiCTR2200066840.