Catalona William J, Hudson M'liss A, Scardino Peter T, Richie Jerome P, Ahmann Frederick R, Flanigan Robert C, DeKernion Jean B, Ratliff Timothy L, Kavoussi Louis R, Dalkin Bruce L, Waters W Bedford, MacFarlane Michael T, Southwick Paula C
Division of Urologic Surgery, Washington University School of Medicine, St. Louis, Missouri.
J Urol. 1994 Dec;152(6 Pt 1):2037-42. doi: 10.1016/s0022-5347(17)32300-5.
A prospective clinical trial of prostate cancer screening was conducted at 6 university centers including 6,630 men 50 years old or older who underwent a serum prostate specific antigen (PSA) determination and digital rectal examination. Biopsies were performed if the PSA level was greater than 4.0 ng./ml. (Hybritech Tandem assay) or digital rectal examination was suspicious for cancer. We evaluated the effect on biopsy rate and cancer detection if the cutoff value was shifted from 4.0 to age-specific reference ranges recommended in the literature. In men 50 to 59 years old with normal digital rectal examination findings a decrease from 4.0 to 3.5 ng./ml. would have resulted in a 45% increase in the number of biopsies (39 of 87) and a projected 15% increase in cancer detection. An increase from 4.0 to 4.5 ng./ml. in men 60 to 69 years old would result in 15% fewer biopsies (35 of 238) and would miss 8% of the organ confined tumors (2 of 25). Increasing the cutoff to 6.5 ng./ml. in men 70 years old or older would result in 44% fewer biopsies (70 of 159) and would miss 47% of the organ confined cancers (7 of 15). The number of biopsies performed for each cancer detected with a PSA level of greater than 4.0 ng./ml. remains constant across age groupings, which suggests that the cutoff of 4.0 ng./ml. does not need to be altered in the older men, since it is apparently unaffected by the simultaneously increasing prevalence of benign prostatic hyperplasia and cancer with age. We conclude that a serum PSA concentration of 4.0 ng./ml. should be used as a general guideline for biopsy in all age groups.
一项前列腺癌筛查的前瞻性临床试验在6所大学中心开展，共有6630名50岁及以上男性参与，他们均接受了血清前列腺特异性抗原（PSA）检测和直肠指检。如果PSA水平大于4.0 ng/ml（Hybritech Tandem检测法）或直肠指检怀疑有癌症，则进行活检。我们评估了若将临界值从4.0改为文献中推荐的年龄特异性参考范围，对活检率和癌症检测的影响。在直肠指检结果正常的50至59岁男性中，将临界值从4.0降至3.5 ng/ml会使活检数量增加45%（87例中的39例），预计癌症检测增加15%。在60至69岁男性中，将临界值从4.0增至4.5 ng/ml会使活检数量减少15%（238例中的35例），并会漏诊8%的局限性肿瘤（25例中的2例）。在70岁及以上男性中，将临界值增至6.5 ng/ml会使活检数量减少44%（159例中的70例），并会漏诊47%的局限性癌症（15例中的7例）。PSA水平大于4.0 ng/ml时，每个检测出的癌症所进行的活检数量在各年龄组中保持不变，这表明4.0 ng/ml的临界值在老年男性中无需改变，因为它显然不受随年龄增长同时出现的良性前列腺增生和癌症患病率增加的影响。我们得出结论，血清PSA浓度4.0 ng/ml应作为所有年龄组活检的通用指南。
