Division of Urologic Surgery, Washington University School of Medicine, St. Louis, Missouri; Division of Urologic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Divisions of Urology and Hematology-Oncology, University of Arizona College of Medicine and Tucson Veterans Affairs Medical Center, Tucson, Arizona; Scott Department of Urology, Baylor College of Medicine, Houston, Texas; Department of Urology, Loyola University Medical Center, Chicago, Illinois; Division of Urology, UCLA School of Medicine, Los Angeles and Department of Clinical Research, Hybritech Incorporated, San Diego, California.
J Urol. 2017 Feb;197(2S):S200-S207. doi: 10.1016/j.juro.2016.10.073. Epub 2016 Dec 22.
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 Tandom-E or Tandem-R assays) and digital rectal examination. Quadrant biopsies were performed if the PSA level was greater than 4 μg./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 μg./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 μg./l. or digital rectal examination is suspicious for cancer, even in the absence of abnormal transrectal ultrasonography findings.
为了比较直肠指检和血清前列腺特异抗原（PSA）在前列腺癌早期诊断中的疗效，我们在 6 个大学中心进行了一项前瞻性临床试验，共有 6630 名 50 岁以上的男性志愿者接受了 PSA 测定（Hybritech Tandom-E 或 Tandem-R 检测）和直肠指检。如果 PSA 水平大于 4μg/L 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 4μg/L，15%直肠指检可疑，26%的男性两项或其中一项检查可疑。在进行的 1167 例活检中，发现 264 例癌症。PSA 检测到的肿瘤明显多于直肠指检（82%，216/264 例与 55%，146/264 例，p=0.001）。直肠指检的癌症检出率为 3.2%，PSA 为 4.6%，两者联合为 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%）为器官局限型癌症：PSA 检测到 85 例（75%），直肠指检检测到 64 例（56%，p=0.003）。联合使用这两种方法比单独使用直肠指检可增加 78%（50/64 例）的器官局限型疾病检出率。如果需要进行可疑的经直肠超声检查，几乎会错过 40%的肿瘤。我们的结论是，PSA 联合直肠指检可提高早期前列腺癌的检出率。如果 PSA 水平大于 4μg/L 或直肠指检怀疑癌症，即使经直肠超声检查无异常，也应考虑进行前列腺活检。
