PSA Standardization
Elevated PSA Result on Screening
October 2009
Over the past two decades the incidence of prostate cancer has increased dramatically. Prostate cancer is the most common cancer diagnosed in North American males, excluding skin cancers. It is the second leading cause of cancer death in males, second only to lung cancer.
Use of serum prostate specific antigen (or PSA) for prostate cancer screening is largely responsible for the increases, and epidemiological data suggests it is not only a higher frequency of cancer diagnosis but mortality has decreased because the cancer is being diagnosed at an earlier stage, allowing for earlier treatment. An elevated PSA result obtained upon screening can signify several things. An increased PSA could signal prostate cancer, with adenocarcinoma the most frequent type.
Other types of prostate cancer include small cell undifferentiated carcinoma, which is a rare, life-threatening form; transitional cell carcinomas, sarcomas of stromal origin, or can originate as metastases from other organs. It is important to recognize that the differential diagnosis of the type of prostate cancer cannot be made with PSA alone. An elevated PSA can also be due to benign prostatic hyperplasia, or BPH, which is thought of as more of a quality of life disease. BPH is relatively common, with an estimated incidence of approximately one quarter of males over the age of 40 and up to 80% of men 80 years or older.
There are other reasons a PSA is elevated and include prostatitis, a condition which lacks clear diagnostic criteria, or there could be analytical issues. The challenge for physicians is to distinguish between these various conditions and determine the cause of an elevated PSA. In addition, the decision to perform a prostate biopsy is often made based upon the PSA screening result.
Elevated PSA Result |
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?


