van Iersel M P, Thomas C M, Segers M F, Witjes W P, Debruyne F M, Oosterhof G O
Department of Urology, University Hospital of Nijmegen St. Radboud, The Netherlands.
Br J Urol. 1996 Mar;77(3):418-22. doi: 10.1046/j.1464-410x.1996.91017.x.
To determine the gain in lead time obtained when using ultrasensitive prostate-specific antigen (PSA) assays in the diagnosis of biochemical progression after radical prostatectomy.
The post-operative PSA serum concentrations of 137 patients who had undergone radical prostatectomy were evaluated retrospectively. From these patients, 12 were selected who showed biochemical recurrence, as measured by the Hybritech Tandem-E Singlepoint PSA assay. Samples of the serum frozen at the time of the initial analysis were thawed and PSA values were remeasured by the Abbott IMx PSA assay and the Tandem-E Multipoint PSA assay. Analytical thresholds (zero-dose + 3 SD) for the Tandem-E Singlepoint, IMx and Tandem-E Multipoint assay were 1.0, 0.04 and 0.04 ng/mL, respectively. The lead time to the detection of a recurrence obtained when using the IMx and the Tandem-E Multipoint PSA assay was compared with that attained using the Tandem-E Singlepoint PSA assay. As a control, PSA values were determined in 58 serum specimens of nine patients having no evidence of recurrence after radical prostatectomy.
All 58 control specimens had PSA levels below the analytical thresholds of the three assays, except one which had a PSA serum concentration of 0.08 ng/mL, estimated by the IMx assay. When compared with the lead time obtained with the Tandem-E Singlepoint assay, the 12 patients with a biochemical recurrence had a median gain in lead time of 327 days (range 60-627) with the IMx assay and of 369 days (range 60-639) with the Tandem-E Multipoint assay.
A PSA value > 0.04 ng/mL after radical prostatectomy heralds further biochemical progression. The use of the ultrasensitive IMx and the Tandem-E Multipoint assays provided more lead time, but there is no clear evidence that this gain is necessarily of benefit to the patient.
确定在根治性前列腺切除术后使用超敏前列腺特异性抗原（PSA）检测法诊断生化进展时所获得的提前期增益。
对137例行根治性前列腺切除术患者的术后PSA血清浓度进行回顾性评估。从这些患者中，选取12例经Hybritech Tandem-E单点PSA检测法测定显示生化复发的患者。将初次分析时冻存的血清样本解冻，用雅培IMx PSA检测法和Tandem-E多点PSA检测法重新测定PSA值。Tandem-E单点、IMx和Tandem-E多点检测法的分析阈值（零剂量+3标准差）分别为1.0、0.04和0.04 ng/mL。将使用IMx和Tandem-E多点PSA检测法检测复发的提前期与使用Tandem-E单点PSA检测法所达到的提前期进行比较。作为对照，测定了9例根治性前列腺切除术后无复发证据患者的58份血清标本的PSA值。
所有58份对照标本的PSA水平均低于三种检测法的分析阈值，但有1份标本经IMx检测法测定的PSA血清浓度为0.08 ng/mL。与Tandem-E单点检测法获得的提前期相比，12例生化复发患者使用IMx检测法的提前期中位数增益为327天（范围60 - 627天），使用Tandem-E多点检测法的提前期中位数增益为369天（范围60 - 639天）。
根治性前列腺切除术后PSA值>0.04 ng/mL预示着进一步的生化进展。使用超敏IMx和Tandem-E多点检测法可提供更多的提前期，但尚无明确证据表明这种增益必然对患者有益。
