Lange P H, Ercole C J, Lightner D J, Fraley E E, Vessella R
Department of Urologic Surgery, University of Minnesota Hospital and Clinic, Minneapolis.
J Urol. 1989 Apr;141(4):873-9. doi: 10.1016/s0022-5347(17)41037-8.
We evaluated serum prostate specific antigen before and after radical prostatectomy. In 100 consecutive patients who underwent radical prostatectomy, preoperative prostate specific antigen levels tended to increase with the increasing severity of pathological stage. However, even at levels of greater than 10 ng. per ml. the positive and negative predictive values (78 and 61 per cent, respectively) of prostate specific antigen to predict extracapsular disease were not sufficient to make this test useful alone for staging. In theory, after radical prostatectomy prostate specific antigen should be zero if no remaining prostatic tissue is present. Tests of precision and analytical sensitivity in our laboratory using a commercial prostate specific antigen assay revealed that a value of 0.4 ng. per ml. or more is different from zero at a greater than 95 per cent confidence level. With this guideline we evaluated the meaning of prostate specific antigen levels 3 to 6 months after radical prostatectomy in 59 men. Among men whose prostate specific antigen level was less than 0.4 ng. per ml. only 9 per cent demonstrated recurrence as evidenced by the development of positive bone scan or progressively elevated prostate specific antigen levels within 6 to 50 months. Alternatively, in men whose 3 to 6-month prostate specific antigen level was 0.4 ng per ml. or more there was evidence of recurrence in 100 per cent within 6 to 49 months (p less than 0.0001). Progressively elevated (more than 0.4 ng. per ml.) prostate specific antigen levels preceded recurrence from 12 to 43 months in all 6 patients who had positive bone scans, while increasing prostate specific antigen levels since radical prostatectomy have continued from 9 to 65 months in the 11 patients who have no radiological evidence of recurrent disease to date. Prostatic acid phosphatase serum values after radical prostatectomy were not useful to predict persistent disease. Prostate specific antigen values 3 to 6 months after radical prostatectomy are a sensitive indicator of persistent disease after radical prostatectomy and often precede other evidence of this occurrence by many years. This fact may alter concepts about surgical results, and possibly shorten and sharpen clinical studies involving adjuvant therapy after radical prostatectomy.
我们评估了根治性前列腺切除术前及术后的血清前列腺特异性抗原水平。在100例连续接受根治性前列腺切除术的患者中，术前前列腺特异性抗原水平往往随着病理分期严重程度的增加而升高。然而，即使前列腺特异性抗原水平高于10 ng/ml，其预测包膜外疾病的阳性和阴性预测值（分别为78%和61%）也不足以使该检测单独用于分期。理论上，如果没有残留前列腺组织，根治性前列腺切除术后前列腺特异性抗原应为零。我们实验室使用一种商业化的前列腺特异性抗原检测方法进行的精密度和分析灵敏度测试显示，0.4 ng/ml或更高的值在大于95%的置信水平下与零有差异。按照这一标准，我们评估了59名男性根治性前列腺切除术后3至6个月前列腺特异性抗原水平的意义。前列腺特异性抗原水平低于0.4 ng/ml的男性中，只有9%出现复发，表现为骨扫描阳性或在6至50个月内前列腺特异性抗原水平逐渐升高。相反，在3至6个月前列腺特异性抗原水平为0.4 ng/ml或更高的男性中，100%在6至49个月内出现复发证据（p<0.0001）。在所有6例骨扫描阳性的患者中，前列腺特异性抗原水平逐渐升高（高于0.4 ng/ml）在复发前12至43个月出现，而在11例迄今无复发疾病影像学证据的患者中，自根治性前列腺切除术后前列腺特异性抗原水平升高持续了9至65个月。根治性前列腺切除术后前列腺酸性磷酸酶血清值对预测持续性疾病无用。根治性前列腺切除术后3至6个月的前列腺特异性抗原值是根治性前列腺切除术后持续性疾病的敏感指标，且通常比该情况的其他证据早很多年出现。这一事实可能会改变关于手术结果的观念，并可能缩短和细化涉及根治性前列腺切除术后辅助治疗的临床研究。
