Precise Test Need
The present test for prostate cancer involves the analysis of the Prostate-Specific Antigen (PSA) concentration in a blood sample and a digital rectal examination (DRE) to check on prostate gland abnormalities. Since the PSA test is organ, and not tumor specific, it has a low positive predictive value of only 30% [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. A more accurate diagnosis depends on an image screening and a controlled, intrusive biopsy of the prostate gland (Bx). A False positive PSA test can lead to the over-diagnosis and the often harmful, over-treatment of the condition.
Small improvements have raised PSA test 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.
Prostac®' addresses the unmet need for a single, precise test for the early detection and risk stratification analysis of prostate cancer.
[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
Prostate Cancer Diagnostic Issues
Diagnostic Test
PSA Test
DRE
Gleason
Score
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If positive PSA Test
Image
(CT Scan, MRI
Biopsy
Risk Stratification Test
Prostate-Specific Antigen (PSA) test is inconclusive:
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POSITIVE test doesn’t mean you have prostate cancer
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NEGATIVE test doesn’t mean you don’t have it.
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PSA is not a test for the early diagnosis of prostate cancer.
Image Screening and biopsy(s) are needed for a more accurate cancer diagnosis.
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Costly, intrusive and often harmful
Treatments
Radiation
Chemotherapy Medications
Hormones
Prostatectomy
Surveillance
Over Diagnosis and Overtreatment:
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Over diagnosing leads to potentially harmful overtreatments (radiation, chemotherapy, prostatectomy).
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Exposes a man to major health complications (urinary incontinence, erectile dysfunction, and mortality).