Ellis W J, Vessella R L, Noteboom J L, Lange P H, Wolfert R L, Rittenhouse H G
Department of Urology, University of Washington, Seattle VA Medical Center, 98195, USA.
Urology. 1997 Oct;50(4):573-9. doi: 10.1016/S0090-4295(97)00251-3.
Treatment failure after radical prostatectomy is most commonly heralded by an increase in serum prostate-specific antigen (PSA) to detectable levels. We evaluated the clinical utility of an ultrasensitive chemiluminescent PSA assay.
We evaluated the assay in banked sera obtained from 170 men after radical prostatectomy. Controls consisted of 142 females, 29 men who had undergone cystoprostatectomy without evidence of prostate cancer, and 25 men without evidence of recurrent disease at least 5 years after prostatectomy for organ-confined disease. Lead time to diagnosis of recurrence was based on comparisons with the IMx or Tandem E assays using a cutoff of 0.1 ng/mL (100 pg/mL).
The biologic level of detection of this assay is 8 pg/mL. Serum PSA levels were undetectable in 82.4% of females, 86.2% of the cystoprostatectomy patients, and 96% of the radical prostatectomy controls. After radical prostatectomy, PSA levels were undetectable at last check in 104 of 168 (61.9%) men. In the 24 men with prostate cancer recurrence, the enhanced sensitivity of 8 pg/mL provided a mean lead time based on conservative calculations of 12.7 to 22.5 months over conventional assays. Thirty-four of the 41 men with detectable PSA levels and no evidence of disease recurrence had PSA levels of 30 pg/mL or less.
PSA levels are undetectable in most men who do not have recurrence of disease after radical prostatectomy. Low but detectable serum PSA levels less than or equal to 30 pg/mL can be produced by nonmalignant sources of PSA. PSA assays with enhanced sensitivity can detect recurrent prostate cancer with significant lead time over conventional assays.
根治性前列腺切除术后治疗失败最常见的表现是血清前列腺特异性抗原（PSA）升高至可检测水平。我们评估了一种超灵敏化学发光PSA检测法的临床实用性。
我们对170例根治性前列腺切除术后男性的储存血清进行了该检测法评估。对照组包括142名女性、29名接受了膀胱前列腺切除术但无前列腺癌证据的男性以及25名因局限性疾病行前列腺切除术后至少5年无疾病复发证据的男性。复发诊断的提前期是基于与IMx或Tandem E检测法进行比较得出的，临界值为0.1 ng/mL（100 pg/mL）。
该检测法的生物学检测水平为8 pg/mL。82.4%的女性、86.2%的膀胱前列腺切除术患者以及96%的根治性前列腺切除术对照组的血清PSA水平检测不到。根治性前列腺切除术后，168名男性中的104名（61.9%）在最后一次检查时PSA水平检测不到。在24例前列腺癌复发的男性中，8 pg/mL的增强灵敏度基于保守计算比传统检测法平均提前12.7至22.5个月。41名PSA水平可检测但无疾病复发证据的男性中，有34名的PSA水平为30 pg/mL或更低。
大多数根治性前列腺切除术后未复发疾病的男性PSA水平检测不到。非恶性来源的PSA可产生低于或等于30 pg/mL的低但可检测的血清PSA水平。灵敏度增强的PSA检测法比传统检测法能提前很长时间检测到复发性前列腺癌。
