Catalona William J, Richie Jerome P, Ahmann Frederick R, Hudson M'Liss A, Scardino Peter T, 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 May;151(5):1283-90. doi: 10.1016/s0022-5347(17)35233-3.
To compare the efficacy of digital rectal examination and serum prostate specific antigen (PSA) in the early detection of prostate cancer, we conducted a prospective clinical trial at 6 university centers of 6,630 male volunteers 50 years old or older who underwent PSA determination (Hybritech Tandem-E or Tandem-R assays) and digital rectal examination. Quadrant biopsies were performed if the PSA level was greater than 4 micrograms/l or digital rectal examination was suspicious, even if transrectal ultrasonography revealed no areas suspicious for cancer. The results showed that 15% of the men had a PSA level of greater than 4 micrograms/l, 15% had a suspicious digital rectal examination and 26% had suspicious findings on either or both tests. Of 1,167 biopsies performed cancer was detected in 264. PSA detected significantly more tumors (82%, 216 of 264 cancers) than digital rectal examination (55%, 146 of 264, p = 0.001). The cancer detection rate was 3.2% for digital rectal examination, 4.6% for PSA and 5.8% for the 2 methods combined. Positive predictive value was 32% for PSA and 21% for digital rectal examination. Of 160 patients who underwent radical prostatectomy and pathological staging 114 (71%) had organ confined cancer: PSA detected 85 (75%) and digital rectal examination detected 64 (56%, p = 0.003). Use of the 2 methods in combination increased detection of organ confined disease by 78% (50 of 64 cases) over digital rectal examination alone. If the performance of a biopsy would have required suspicious transrectal ultrasonography findings, nearly 40% of the tumors would have been missed. We conclude that the use of PSA in conjunction with digital rectal examination enhances early prostate cancer detection. Prostatic biopsy should be considered if either the PSA level is greater than 4 micrograms/l or digital rectal examination is suspicious for cancer, even in the absence of abnormal transrectal ultrasonography findings.
为比较直肠指检和血清前列腺特异性抗原（PSA）在前列腺癌早期检测中的效果，我们在6所大学中心对6630名50岁及以上的男性志愿者进行了一项前瞻性临床试验，这些志愿者均接受了PSA测定（Hybritech Tandem - E或Tandem - R检测法）和直肠指检。如果PSA水平大于4微克/升或直肠指检可疑，即使经直肠超声检查未发现可疑癌症区域，也进行象限活检。结果显示，15%的男性PSA水平大于4微克/升，15%的男性直肠指检可疑，26%的男性在一项或两项检查中有可疑结果。在进行的1167次活检中，发现了264例癌症。PSA检测出的肿瘤显著多于直肠指检（82%，264例癌症中的216例对55%，264例中的146例，p = 0.001）。直肠指检的癌症检出率为3.2%，PSA为4.6%，两种方法联合为5.8%。PSA的阳性预测值为32%，直肠指检为21%。在160例行根治性前列腺切除术和病理分期的患者中，114例（71%）有器官局限性癌症：PSA检测出85例（75%），直肠指检检测出64例（56%，p = 0.003）。两种方法联合使用比单独直肠指检增加了78%（64例中的50例）的器官局限性疾病检测率。如果活检需要经直肠超声检查有可疑结果，将近40%的肿瘤会被漏诊。我们得出结论，PSA与直肠指检联合使用可提高前列腺癌的早期检测率。如果PSA水平大于4微克/升或直肠指检可疑有癌症，即使经直肠超声检查无异常结果，也应考虑进行前列腺活检。
