Evaluation of the diagnostic value of YiDiXie™-SS in PSA-positive patients

BackgroundProstate cancer is one of the most common malignant tumors and poses a substantial threat to human health. PSA or enhanced MRI is widely used in prostate cancer screening or diagnosis. However, false-positive results of PSA or enhanced MRI will lead to unnecessary puncture biopsy, and patients will have to bear the adverse consequences of mental pain, expensive examination costs, and examination injuries; whereas false-negative results of PSA or enhanced MRI will lead to delayed treatment, and patients will have to bear the adverse consequences of poor prognosis, expensive treatment costs, poor quality of life, and short survival period. There is an urgent need to find convenient, economical and non-invasive diagnostic methods to reduce the PSA or enhanced MRI false-negative and false-positive rates. The aim of this study was to evaluate the diagnostic value of YiDiXie-SS and YiDiXie-HS in prostate cancer. Patients and methodsThe study finally included 464 subjects with positive PSA test (prostate cancer group, n=292; BPH group, n=172). Remaining serum samples from the subjects were collected and tested with YiDiXie all-cancer detection kit. The sensitivity and specificity of YiDiXie-SS and YiDiXie-HS were evaluated respectively. ResultsThe sensitivity of YiDiXie-SS was 100% (95% CI: 98.7% - 100%; 292/292) and its specificity was 60.5% (95% CI: 53.0% - 67.5%; 104/172). As shown in Table 3, the sensitivity of YiDiXie-HS was 93.8% (95% CI: 90.5% - 96.1%; 274/292) and its specificity was 86.0% (95% CI: 80.1% - 90.4%; 148/172). The sensitivity of YiDiXie-SS in PSA-positive patients was 100% (95% CI: 98.6% - 100%; 279/279), and the specificity was 58.0% (95% CI: 49.8% - 65.2%; 90/ 156). This means that the application of YiDiXie-SS reduces the PSA false-positive rate by 58.0% (95% CI: 49.8% - 65.2%; 90/156) with essentially no increase in malignancy leakage. The sensitivity of YiDiXie-HS in PSA-negative patients was 92.3% (95% CI: 66.7% - 99.6%; 12/13), and the specificity was 81.3% (95% CI: 57.0% - 93.4%; 13/ 16). This means that the application of YiDiXie-HS reduced the PSA false negative rate by 92.3% (95% CI: 66.7% - 99.6%; 12/13). YiDiXie-SS had a sensitivity of 100% (95% CI: 97.6% - 100%; 159/159) and a specificity of 59.6% (95% CI: 49.5% - 68.9%; 56/94) in enhanced MRI-positive patients. This means that the application of YiDiXie-SS reduces the false-positive rate of enhanced MRI by 59.6% (95% CI: 49.5% - 68.9%; 56/94) with essentially no increase in malignancy leakage. the sensitivity of YiDiXie-HS in enhanced MRI-negative patients was 90.2% (95% CI: 79.0% - 95.7%; 46/51), and the specificity was 83.3% (95% CI: 55.2% - 97.0%; 10/12). This means that the application of YiDiXie-HS reduced the false negative rate of enhanced MRI by 90.2% (95% CI: 79.0% - 95.7%; 46/51). O_TBL View this table: org.highwire.dtl.DTLVardef@11a3a26org.highwire.dtl.DTLVardef@dfb213org.highwire.dtl.DTLVardef@24332forg.highwire.dtl.DTLVardef@9c6e6eorg.highwire.dtl.DTLVardef@15f918_HPS_FORMAT_FIGEXP M_TBL O_FLOATNOTable 3.C_FLOATNO O_TABLECAPTIONThe performance of YiDiXie-HS C_TABLECAPTION C_TBL ConclusionYiDiXie-SS significantly reduces the false-positive rate of PSA or enhanced MRI-positive patients without increasing the number of under-diagnosed malignant tumors. YiDiXie-HS significantly reduces the false-negative rate of PSA or enhanced MRI-negative patients. YiDiXie-SS and YiDiXie-HS can play an important role in prostate cancer, and are expected to solve the problem of "high false-positive rate of PSA or enhanced MRI" and "high false-negative rate of PSA or enhanced MRI". Clinical trial numberChiCTR2200066840.