PSA Standardization

Recommendations for Screening

October 2009

Several clinical groups have advocated the benefits of screening for prostate cancer.  These groups include the American Urological Association, who recommend screening men beginning at age 50 and have a life expectancy of at least 10 years, and even earlier in African-American men or those who have a family history of prostate cancer.

The American Cancer Society has similar guidelines to the American Urological Association, although include a digital rectal exam with the PSA.  The National Comprehensive Cancer Network recommends using a PSA cutoff of 2.5 ng/mL, which is lower than the 4.0 ng/mL cutoff traditionally used.  Endorsement of prostate cancer screening also comes from the National Academy of Clinical Biochemistry, and all groups recommend that a positive PSA be repeated prior to prostate biopsy.

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Recommendations for Screening

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Jump to section:

• Introduction
• Elevated PSA Result on Screening
• Reasons for Ordering PSA¹
• PSA Screening in the News
• Recommendations for Screening
• Arguments for Screening for Prostate Cancer
• Recommendations for Not Screening
• Arguments Against Screening for Prostate Cancer
• PSA Sensitivity and Specificity
• High-Grade Prostate Cancer is Not Rare When PSA =4.0 ng/mL⁶
• Increase Specificity Using PSA Velocity⁸
• Optimizing Clinical Sensitivity and Specificity: Age/Ethnic Reference Intervals^9,10
• Utilization of Free/Total PSA Ratio¹¹
• Why Aren't PSA Results Interchangeable?
• Development of PSA Standards
• Development of PSA Standards
• Effect of Analytical Bias on Classification Based on Fixed Criteria
• Analytical Difference: Results per 1000 Patients Tested¹³
• Hybritech vs. WHO Standardized Assays^12,14
• Analytical Differences¹⁵
• CAP Proficiency Testing
• WHO 96/670 Total PSA Preparations¹⁶
• WHO Calibration/Concordance at 3.1 ng/mL Cutoff⁵
• WHO Calibration/Concordance at 3.1 ng/mL Cutoff⁵
• WHO Calibration/Concordance at 4.0 ng/mL Cutoff⁵
• Clinical Differences in PSA Screening¹⁴
• The Clinical Difference
• Fixed Thresholds Produce Problems for Biopsy Recommendations
• Effect on "Watchful Waiting"
• Effect on "Watchful Waiting"
• Adding Biological Variability into the Mix
• Futures in Prostate Cancer Testing?
• PSA Testing at Mayo
• Conclusions
• References
• References
• Questions?