Abstract
PurposeTo develop a magneto-nanosensor (MNS) based multiplex assay to measure protein and autoantibody biomarkers from human serum for prostate cancer (CaP) diagnosis.Materials and methodsA 4-panel MNS autoantibody assay and a MNS protein assay were developed and optimized in our labs. Using these assays, serum concentration of six biomarkers including prostate-specific antigen (PSA) protein, free/total PSA ratio, as well as four autoantibodies against Parkinson disease 7 (PARK7), TAR DNA-binding protein 43 (TARDBP), Talin 1 (TLN1), and Caldesmon 1 (CALD1) and were analyzed. Human serum samples from 99 patients (50 with non-cancer and 49 with clinically localized CaP) were evaluated.ResultsThe MNS assay showed excellent performance characteristics and no cross-reactivity. All autoantibody assays showed a statistically significant difference between CaP and non-cancer samples except for PARK7. The most significant difference was the combination of the four autoantibodies as a panel in addition to the free/total PSA ratio. This combination had the highest area under the curve (AUC)– 0.916 in ROC analysis.ConclusionsOur results suggest that this autoantibody panel along with PSA and free PSA have potential to segregate patients without cancer from those with prostate cancer with higher sensitivity and specificity than PSA alone.
Highlights
Prostate cancer (CaP) constitutes a major health burden in men
This combination had the highest area under the curve (AUC)– 0.916 in Receiver operating characteristic (ROC) analysis
Our results suggest that this autoantibody panel along with Prostate Specific Antigen (PSA) and free PSA have potential to segregate patients without cancer from those with prostate cancer with higher sensitivity and specificity than PSA alone
Summary
Prostate cancer (CaP) constitutes a major health burden in men. In 2017, it is estimated that over 160,000 men were diagnosed with CaP, and it remains the second leading cause of cancer-related deaths in men [1]. Because of its prolonged natural history and potential curability while localized, CaP has been regarded as the optimal cancer for screening approaches as a means of reducing mortality. Starting in the late 1980s, serum Prostate Specific Antigen (PSA) testing began to be used for CaP screening and became widespread in the U.S over the decade. While the European Randomized Study of Screening for Prostate Cancer (ERSPC) showed small but significant improvements in CaP mortality with PSA screening, the Prostate Lung Colon Ovarian (PLCO) screening study showed PSA testing led to many unnecessary biopsies that caused significant morbidities including pain, sepsis, bleeding, and overdiagnosis. While the European Randomized Study of Screening for Prostate Cancer (ERSPC) showed small but significant improvements in CaP mortality with PSA screening, the Prostate Lung Colon Ovarian (PLCO) screening study showed PSA testing led to many unnecessary biopsies that caused significant morbidities including pain, sepsis, bleeding, and overdiagnosis. [2,3,4]
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