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PSA Standardization

PSA Sensitivity and Specificity

Slide 9

October 2009

The well known total PSA cutoff of 4.0 ng/mL was first proposed in 1986 from a study conducted by the company Hybritech, who evaluated a small population of 472 men without a history of prostate cancer. 
A further screening study performed at Washington University involved 6630 men aged 50-74 years, and led to the approval of PSA by the US Food and Drug Administration for prostate cancer screening.  This study clearly demonstrated the efficacy of the 4.0 ng/mL cutoff, which at the time, was considered an aggressive stance.  A cutoff of 10.0 ng/mL was used commonly for triggering prostate biopsies in the early 1990’s.

Consequently, 4.0 ng/mL became well recognized as “the” biopsy cutoff, even though it was well known that men could have cancer with PSA values less than 4.0 ng/mL, and that values greater than 4 produced a 6/2% false-positive rate and detected only 20% of cases.

PSA Sensitivity and Specificity


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