PSA Standardization
PSA Screening in the News
October 2009
There have been two large clinical trials published very recently in the New England Journal of Medicine that reported results from randomized trials which evaluated the effectiveness of PSA screening.
One of those trials was the American Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial, which recruited approximately 77,000 men between the ages of 55 and 74 years. Participants were placed in either a control group or a group which received a PSA test and digital rectal exam every year for six years. The group that had PSA screening had a 20% increase in the diagnosis rate of cancer; however, the stage and grade of cancer diagnosed was similar to that of the control group. There was no reduction in the rate of prostate cancer deaths due to screening, and there was study contamination due to the fact that about half of the men in the control group had already had a PSA test before or during the trial at some point.
The European Randomized Study of Screening for Prostate Cancer reported on approximately 162,000 men followed for an average of nine years. In this study there were 70% more cases of metastatic cancer and more than twice as many locally advanced cases in the control group compared to the group that underwent regular screening. There was a 20% reduction in death from prostate cancer in the screening group, however the reduction was minimal. The chance of dying from prostate cancer after nine years was reduced from 0.36% to 0.29%.
Furthermore a recent Dartmouth study suggests there have been an estimated 1 million excess diagnoses since 1986, yet the incidence of prostate cancer remains well above the levels that existed prior to widespread PSA screening.
Screening in the News |
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 Intervals9,10
- 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 Assays12,14
- 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?


