Eastham James A, Riedel Elyn, Scardino Peter T, Shike Moshe, Fleisher Martin, Schatzkin Arthur, Lanza Elaine, Latkany Lianne, Begg Colin B
Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
JAMA. 2003 May 28;289(20):2695-700. doi: 10.1001/jama.289.20.2695.
Serum prostate-specific antigen (PSA) testing is frequently used in early detection programs for prostate cancer. While PSA testing has resulted in an increase in prostate cancer detection, its routine use has been questioned because of a lack of specificity.
To determine whether year-to-year fluctuations in PSA levels are due to natural variation and render a single PSA test result unreliable.
DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of an unscreened population of 972 men (median age, 62 years) participating in the Polyp Prevention Trial (1991-1998). Five consecutive blood samples were obtained during a 4-year period and were assessed for total and free PSA levels.
Abnormal PSA test result based on a PSA level higher than 4 ng/mL; a PSA level higher than 2.5 ng/mL; a PSA level above the age-specific cutoff; a PSA level in the range of 4 to 10 ng/mL and a free-to-total ratio of less than 0.25 ng/mL; or a PSA velocity higher than 0.75 ng/mL per year.
Prostate biopsy would have been recommended in 207 participants (21%) with a PSA level higher than 4 ng/mL; in 358 (37%) with a level higher than 2.5 ng/mL; in 172 (18%) with a level above the age-specific cutoff; in 190 (20%) with a level between 4 and 10 ng/mL and a free-to-total ratio of less than 0.25 ng/mL; and in 145 (15%) with a velocity higher than 0.75 ng/mL per year. Among men with an abnormal PSA finding, a high proportion had a normal PSA finding at 1 or more subsequent visits during 4-year follow-up: 68 (44%) of 154 participants with a PSA level higher than 4 ng/mL; 116 (40%) of 291 had a level higher than 2.5 ng/mL; 64 (55%) of 117 had an elevated level above the age-specific cutoff; and 76 (53%) of 143 had a level between 4 and 10 ng/mL and a free-to-total ratio of less than 0.25 ng/mL.
An isolated elevation in PSA level should be confirmed several weeks later before proceeding with further testing, including prostate biopsy.
血清前列腺特异性抗原(PSA)检测常用于前列腺癌的早期检测项目。虽然PSA检测使前列腺癌的检出率有所提高,但其常规应用因缺乏特异性而受到质疑。
确定PSA水平的逐年波动是否是由于自然变异导致,从而使单次PSA检测结果不可靠。
设计、地点和参与者:对参与息肉预防试验(1991 - 1998年)的972名男性(中位年龄62岁)的未筛查人群进行回顾性分析。在4年期间采集了5份连续的血样,并对总PSA和游离PSA水平进行了评估。
基于PSA水平高于4 ng/mL、高于2.5 ng/mL、高于年龄特异性临界值、在4至10 ng/mL范围内且游离与总PSA比值低于0.25 ng/mL,或每年PSA速度高于0.75 ng/mL的异常PSA检测结果。
对于PSA水平高于4 ng/mL的207名参与者(21%)、高于2.5 ng/mL的358名(37%)、高于年龄特异性临界值的172名(18%)、在4至10 ng/mL之间且游离与总PSA比值低于0.25 ng/mL的190名(20%)以及每年PSA速度高于0.75 ng/mL的145名(15%),建议进行前列腺活检。在PSA检测结果异常的男性中,很大一部分在4年随访期间的1次或更多次后续就诊时PSA检测结果正常:在PSA水平高于4 ng/mL的154名参与者中有68名(44%);在PSA水平高于2.5 ng/mL的291名中有116名(40%);在PSA水平高于年龄特异性临界值的117名中有64名(55%);在PSA水平在4至10 ng/mL之间且游离与总PSA比值低于0.25 ng/mL的143名中有76名(53%)。
在进行包括前列腺活检在内的进一步检测之前,应在几周后确认PSA水平的孤立升高情况。