Prostate Cancer Diagnostic Gap

There is a diagnostic gap today in the detection of prostate cancer. The initial examination involves the PSA test, a measurement of the concentration of the prostate-specific antigen in the patient's blood, and a digital rectal examination (DRE) which checks on prostate gland abnormalities. 
 
Since the PSA test is organ, and not tumor specific, it has a low positive predictive value of only 30% , meaning only 30% of men who tested with an elevated PSA score > 4 ng/ml are found to have prostate cancer. [1]
 
An incorrect or false positive PSA test for prostate cancer can be triggered by factors that include prostatitis, benign prostatic hyperplasia (BPH), sexual activity, medications, obesity, and exercise.  To address this diagnostic gap, ancillary tests are required, including an image screening and a controlled, intrusive biopsy of the prostate gland (Bx). Still, a False positive PSA test and ancillary tests can over-diagnosis prostate cancer and lead to a harmful over-treatment of the condition. 
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​Small improvements have raised the PSA test's diagnostic accuracy, while new tests help stratify the risk of a clinically significant cancer. However, these tests still do not deliver the required detection and risk stratification accuracy or precision due to the heterogeneous nature of prostate cancer. 
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Prostac™ helps address the present unmet diagnostic gap with a single, precise test for the early detection and risk stratification analysis of prostate cancer.   ​​
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[1] Tokudome S, Ando R, Koda Y. Discoveries and application of prostate specific antigen, and some proposals to optimize prostate cancer screening. Cancer Manag Res; 2016, 8: 45 - 47