Question 1 · Hard
A 64-year-old man had a radical prostatectomy for prostate cancer 3 years ago. His PSA results on the same ultrasensitive assay (limit of quantitation 0.01 µg/L) are below 0.01 µg/L at 3 months after surgery, then, at 6-monthly intervals, 0.03, 0.06, 0.12, 0.24 and 0.29 µg/L. He has no symptoms. His urology team defines biochemical recurrence as a PSA of 0.2 µg/L (ng/mL) or more, confirmed on a second sample. A clinician asks whether the values can be ignored because all are far below 4.0 µg/L. What is the best interpretation?
- AConfirmed biochemical recurrence
- BNormal, as all values are below 4.0 µg/L
- CPSA from regrowing benign prostate
- DAssay noise near the detection limit
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Answer: A · Confirmed biochemical recurrence
After radical prostatectomy the source of PSA has been removed, so PSA should stay undetectable and age-related cut-offs such as 4.0 µg/L do not apply. A steady rise from below 0.01 to 0.24 and then 0.29 µg/L on the same assay is far above its limit of quantitation and is not random noise. Two consecutive values of 0.2 µg/L or more meet the team's definition of biochemical recurrence. The PSA doubled about every 6 months, and this doubling time helps the clinician judge how aggressive the recurrence is. A change of PSA method during follow-up should be avoided or clearly flagged, because results are not interchangeable between assays.
- B: The 4.0 µg/L cut-off applies to men with a prostate; after prostatectomy PSA should be undetectable.
- C: Residual benign tissue gives a low, stable PSA, not one that doubles every 6 months.
- D: The values rise steadily and are far above the 0.01 µg/L limit of quantitation, so they are not noise.