Comparison of Digital Rectal Examination and Serum Prostate Specific Antigen in the Early Detection of Prostate Cancer

Results of a Multicenter Clinical Trial of 6,630 Men

William J. Catalona, Jerome P. Richie, Frederick R. Ahmann, M'Liss A. Hudson, Peter T. Scardino, Robert C. Flanigan, Jean B. DeKernion, Timothy L. Ratliff, Louis R. Kavoussi, Bruce L. Dalkin, W Waters, Michael T. MacFarlane, Paula C. Southwick

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)S200-S207
JournalJournal of Urology
Volume197
Issue number2
DOIs
StatePublished - Feb 1 2017

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Digital Rectal Examination
Prostate-Specific Antigen
Early Detection of Cancer
Multicenter Studies
Prostatic Neoplasms
Clinical Trials
Serum
Neoplasms
Biopsy
Ultrasonography
Prostatectomy
Volunteers

All Science Journal Classification (ASJC) codes

  • Urology

Cite this

Comparison of Digital Rectal Examination and Serum Prostate Specific Antigen in the Early Detection of Prostate Cancer : Results of a Multicenter Clinical Trial of 6,630 Men. / 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; MacFarlane, Michael T.; Southwick, Paula C.

In: Journal of Urology, Vol. 197, No. 2, 01.02.2017, p. S200-S207.

Research output: Contribution to journalArticle

Catalona, WJ, Richie, JP, Ahmann, FR, Hudson, MLA, Scardino, PT, Flanigan, RC, DeKernion, JB, Ratliff, TL, Kavoussi, LR, Dalkin, BL, Waters, W, MacFarlane, MT & Southwick, PC 2017, 'Comparison of Digital Rectal Examination and Serum Prostate Specific Antigen in the Early Detection of Prostate Cancer: Results of a Multicenter Clinical Trial of 6,630 Men', Journal of Urology, vol. 197, no. 2, pp. S200-S207. https://doi.org/10.1016/j.juro.2016.10.073
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 ; MacFarlane, Michael T. ; Southwick, Paula C. / Comparison of Digital Rectal Examination and Serum Prostate Specific Antigen in the Early Detection of Prostate Cancer : Results of a Multicenter Clinical Trial of 6,630 Men. In: Journal of Urology. 2017 ; Vol. 197, No. 2. pp. S200-S207.
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author = "Catalona, {William J.} and Richie, {Jerome P.} and Ahmann, {Frederick R.} and Hudson, {M'Liss A.} and Scardino, {Peter T.} and Flanigan, {Robert C.} and DeKernion, {Jean B.} and Ratliff, {Timothy L.} and Kavoussi, {Louis R.} and Dalkin, {Bruce L.} and W Waters and MacFarlane, {Michael T.} and Southwick, {Paula C.}",
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