Serum prostate-specific antigen in a community-based population of healthy men. Establishment of age-specific reference ranges.
Serum prostate-specific antigen in a community-based population of healthy men. Establishment of age-specific reference ranges.
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DOI：
10.1001/jama.1993.03510070082041
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发表时间：
1993-08
期刊：
影响因子：
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通讯作者：
J. E. Oesterling;S. Jacobsen;C. Chute;H. Guess;C. Girman;Laurei A. Panser;M. Lieber
中科院分区：
文献类型：
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作者：
J. E. Oesterling;S. Jacobsen;C. Chute;H. Guess;C. Girman;Laurei A. Panser;M. Lieber
目的探讨无前列腺癌但有前列腺癌危险的健康男性血清前列腺特异性抗原（PSA）的特征。评估患者年龄和前列腺大小对血清PSA浓度的影响，以便更适当地使用PSA在早期、可能治愈的阶段检测具有临床意义的前列腺癌。设计：前瞻性、社区性研究。参与者1989年12月至1991年3月，2119名来自明尼苏达州奥姆斯特德县的40 - 79岁健康男性参加了一项前瞻性研究，以评估良性前列腺增生的自然史。其中，537例（25%）被随机选择参加详细的临床检查，包括血清PSA测定（Tandem-R PSA测定），直肠指检和经直肠超声检查。471例（88%）完成了前列腺评估，并且通过这三种诊断测试中的任何一种都没有前列腺癌的证据;这些男性形成了进行所有分析的研究人群。主要观察指标血清PSA浓度、前列腺体积和PSA密度（血清PSA水平/前列腺体积）作为患者年龄的函数。结果血清PSA浓度与患者年龄（r = .43; P < .0001）和前列腺体积（r = .55; P < .0001）相关。前列腺体积与患者年龄直接相关（r = 0.43; P <0.0001），而PSA密度值与患者年龄仅弱相关（r = 0.25; P <0.001）。对于没有前列腺癌证据的健康60岁男性，血清PSA浓度每年增加约3.2%（每年0.04 ng/mL）。40 - 49岁男性血清PSA（第95百分位数）的推荐参考范围为0.0 - 2.5 ng/mL; 50 - 59岁为0.0 - 3.5 ng/mL; 60 - 69岁为0.0 - 4.5 ng/mL; 70 - 79岁为0.0 - 6.5 ng/mL。结论血清PSA浓度与患者年龄和前列腺体积直接相关，前列腺体积也与年龄直接相关。因此，与其依赖所有年龄组男性的单一参考范围，不如制定特定年龄的参考范围。这些年龄特异性参考范围有可能使血清PSA成为一种更具鉴别力的肿瘤标志物，用于检测老年男性的临床显著癌症（提高特异性），并在年轻男性中发现更多潜在的可治愈癌症（提高灵敏度）。
OBJECTIVE To define the characteristics of serum prostate-specific antigen (PSA) in a population of healthy men without clinically evident prostate cancer, but who are at risk for developing the malignancy. The influence of patient age and prostatic size on the serum PSA concentration was assessed in order to use PSA more appropriately to detect clinically significant prostate cancer at an early, potentially curable stage. DESIGN Prospective, community-based study. PARTICIPANTS Between December 1989 and March 1991, 2119 healthy men aged 40 to 79 years from Olmsted County, Minnesota, were entered into a prospective study to assess the natural history of benign prostatic hyperplasia. Of these, 537 (25%) were randomly chosen to participate in a detailed clinical examination that included a serum PSA determination (Tandem-R PSA assay), digital rectal examination, and transrectal ultrasonography. Four hundred seventy-one (88%) completed the prostatic evaluation and had no evidence of prostate cancer by any of these three diagnostic tests; these men formed the study population on which all analyses were performed. MAIN OUTCOME MEASURE Serum PSA concentration, prostatic volume, and PSA density (serum PSA level/prostatic volume) as a function of patient age. RESULTS The serum PSA concentration is correlated with patient age (r = .43; P < .0001) and prostatic volume (r = .55; P < .0001). Prostatic volume, in turn, is directly correlated with patient age (r = .43; P < .0001), whereas the PSA density value is only weakly correlated with patient age (r = .25; P < .001). For a healthy 60-year-old man with no evidence of prostate cancer, the serum PSA concentration increases by approximately 3.2% per year (0.04 ng/mL per year). The recommended reference range for serum PSA (95th percentile) for men aged 40 to 49 years is 0.0 to 2.5 ng/mL; for 50 to 59 years, 0.0 to 3.5 ng/mL; 60 to 69 years, 0.0 to 4.5 ng/mL; and 70 to 79 years, 0.0 to 6.5 ng/mL. CONCLUSIONS The serum PSA concentration is directly correlated with patient age and prostatic volume, the latter of which also is directly related to age. Thus, rather than rely on a single reference range for men of all age groups, it is more appropriate to have age-specific reference ranges. These age-specific reference ranges have the potential to make serum PSA a more discriminating tumor marker for detecting clinically significant cancers in older men (increasing specificity) and to find more potentially curable cancers in younger men (increasing sensitivity).