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Japanese Journal of Clinical Oncology 2007 37(6):446-451; doi:10.1093/jjco/hym043
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© 2007 Foundation for Promotion of Cancer Research

Efficiency of Ultrasensitive Prostate-specific Antigen Assay in Diagnosing Biochemical Failure After Radical Prostatectomy

Fumitaka Shimizu1,, Shiro Tanaka2, Yutaka Matsuyama2, Takashi Tominaga3, Yasuo Ohashi2 and Makoto Fujime1

1 Department of Urology, Juntendo University, Tokyo
2 Department of Biostatistics/Epidemiology and Preventive Health Sciences, University of Tokyo, Tokyo
3 Department of Urology, Mitsui Memorial Hospital, Tokyo, Japan

For reprints and all correspondence: Fumitaka Shimizu, Department of Urology, Juntendo University, 3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan. E-mail: fshimizu-jua{at}umin.ac.jp

Received August 9, 2006; accepted February 1, 2007

Background: Ultrasensitive prostate-specific antigen (PSA) is a significant serum biomarker for identifying the PSA nadir and early biochemical failure after radical prostatectomy (RP). We assessed the efficiency of ultrasensitive PSA assay in the follow-up after RP.

Methods: We generated longitudinal ultrasensitive PSA data using a computer program assuming that patients experienced biochemical failure after RP. The simulation experiments, based on several different scenarios, were performed to assess the sensitivity and specificity in the diagnosis of biochemical failure using ultrasensitive PSA values and to estimate the lead time, which is the time advantage of detecting positivity for biochemical failure using the ultrasensitive PSA values compared with conventional PSA assay. We validated the sensitivity, specificity and lead time using actual follow-up data of 182 patients receiving RP.

Results: It was suggested that the sensitivity obtained from the actual data was more similar to that obtained using ultrasensitive PSA with an exponential increase than with a linear increase in the simulation experiments. Diagnosing biochemical failure based on two consecutive increases in the ultrasensitive PSA values was not recommended. Of non-biochemical failure patients, 9.4% showed four consecutive increases in their ultrasensitive PSA values. Average lead time in the actual data was 11.2 months (SD: 10.1).

Conclusions: For an accurate diagnosis of biochemical failure, our findings suggest the importance of a certain duration of follow-up and exclusion of false-positive results afterwards.

Key Words: prostatic neoplasms • prostatectomy • recurrence • prostate-specific antigen • computer simulation


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