A multicenter study of [-2]pro-prostate specific antigen combined with prostate specific antigen and free prostate specific antigen for prostate cancer detection in the 2.0 to 10.0 ng/ml prostate specific antigen range

William J. Catalona, Alan W. Partin, Martin G. Sanda, John T. Wei, George G. Klee, Chris H. Bangma, Kevin M. Slawin, Leonard S. Marks, Stacy Loeb, Dennis L. Broyles, Sanghyuk S. Shin, Amabelle B. Cruz, Daniel W. Chan, Lori J. Sokoll, William L. Roberts, Ron H N Van Schaik, Isaac A. Mizrahi

Research output: Contribution to journalArticle

238 Citations (Scopus)

Abstract

Purpose: Prostate specific antigen and free prostate specific antigen have limited specificity to detect clinically significant, curable prostate cancer, leading to unnecessary biopsy, and detection and treatment of some indolent tumors. Specificity to detect clinically significant prostate cancer may be improved by [-2]pro-prostate specific antigen. We evaluated [-2]pro-prostate specific antigen, free prostate specific antigen and prostate specific antigen using the formula, ([-2]pro-prostate specific antigen/free prostate specific antigen × prostate specific antigen1/2) to enhance specificity to detect overall and high grade prostate cancer. Materials and Methods: We enrolled 892 men with no history of prostate cancer, normal rectal examination, prostate specific antigen 2 to 10 ng/ml and 6-core or greater prostate biopsy in a prospective multi-institutional trial. We examined the relationship of serum prostate specific antigen, free-to-total prostate specific antigen and the prostate health index with biopsy results. Primary end points were specificity and AUC using the prostate health index to detect overall and Gleason 7 or greater prostate cancer on biopsy compared with those of free-to-total prostate specific antigen. Results: In the 2 to 10 ng/ml prostate specific antigen range at 80% to 95% sensitivity the specificity and AUC (0.703) of the prostate health index exceeded those of prostate specific antigen and free-to-total prostate specific antigen. An increasing prostate health index was associated with a 4.7-fold increased risk of prostate cancer and a 1.61-fold increased risk of Gleason score greater than or equal to 4 + 3 = 7 disease on biopsy. The AUC of the index exceeded that of free-to-total prostate specific antigen (0.724 vs 0.670) to discriminate prostate cancer with Gleason 4 or greater + 3 from lower grade disease or negative biopsy. Prostate health index results were not associated with age and prostate volume. Conclusions: The prostate health index may be useful in prostate cancer screening to decrease unnecessary biopsy in men 50 years old or older with prostate specific antigen 2 to 10 ng/ml and negative digital rectal examination with minimal loss in sensitivity.

Original languageEnglish (US)
Pages (from-to)1650-1655
Number of pages6
JournalJournal of Urology
Volume185
Issue number5
DOIs
StatePublished - May 2011

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Prostate-Specific Antigen
Multicenter Studies
Prostatic Neoplasms
Prostate
Biopsy
Health
Area Under Curve
Digital Rectal Examination
Neoplasm Grading
Early Detection of Cancer

Keywords

  • diagnosis
  • mass screening
  • prostate
  • prostate specific antigen
  • prostatic neoplasms

ASJC Scopus subject areas

  • Urology

Cite this

A multicenter study of [-2]pro-prostate specific antigen combined with prostate specific antigen and free prostate specific antigen for prostate cancer detection in the 2.0 to 10.0 ng/ml prostate specific antigen range. / Catalona, William J.; Partin, Alan W.; Sanda, Martin G.; Wei, John T.; Klee, George G.; Bangma, Chris H.; Slawin, Kevin M.; Marks, Leonard S.; Loeb, Stacy; Broyles, Dennis L.; Shin, Sanghyuk S.; Cruz, Amabelle B.; Chan, Daniel W.; Sokoll, Lori J.; Roberts, William L.; Van Schaik, Ron H N; Mizrahi, Isaac A.

In: Journal of Urology, Vol. 185, No. 5, 05.2011, p. 1650-1655.

Research output: Contribution to journalArticle

Catalona, WJ, Partin, AW, Sanda, MG, Wei, JT, Klee, GG, Bangma, CH, Slawin, KM, Marks, LS, Loeb, S, Broyles, DL, Shin, SS, Cruz, AB, Chan, DW, Sokoll, LJ, Roberts, WL, Van Schaik, RHN & Mizrahi, IA 2011, 'A multicenter study of [-2]pro-prostate specific antigen combined with prostate specific antigen and free prostate specific antigen for prostate cancer detection in the 2.0 to 10.0 ng/ml prostate specific antigen range', Journal of Urology, vol. 185, no. 5, pp. 1650-1655. https://doi.org/10.1016/j.juro.2010.12.032
Catalona, William J. ; Partin, Alan W. ; Sanda, Martin G. ; Wei, John T. ; Klee, George G. ; Bangma, Chris H. ; Slawin, Kevin M. ; Marks, Leonard S. ; Loeb, Stacy ; Broyles, Dennis L. ; Shin, Sanghyuk S. ; Cruz, Amabelle B. ; Chan, Daniel W. ; Sokoll, Lori J. ; Roberts, William L. ; Van Schaik, Ron H N ; Mizrahi, Isaac A. / A multicenter study of [-2]pro-prostate specific antigen combined with prostate specific antigen and free prostate specific antigen for prostate cancer detection in the 2.0 to 10.0 ng/ml prostate specific antigen range. In: Journal of Urology. 2011 ; Vol. 185, No. 5. pp. 1650-1655.
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abstract = "Purpose: Prostate specific antigen and free prostate specific antigen have limited specificity to detect clinically significant, curable prostate cancer, leading to unnecessary biopsy, and detection and treatment of some indolent tumors. Specificity to detect clinically significant prostate cancer may be improved by [-2]pro-prostate specific antigen. We evaluated [-2]pro-prostate specific antigen, free prostate specific antigen and prostate specific antigen using the formula, ([-2]pro-prostate specific antigen/free prostate specific antigen × prostate specific antigen1/2) to enhance specificity to detect overall and high grade prostate cancer. Materials and Methods: We enrolled 892 men with no history of prostate cancer, normal rectal examination, prostate specific antigen 2 to 10 ng/ml and 6-core or greater prostate biopsy in a prospective multi-institutional trial. We examined the relationship of serum prostate specific antigen, free-to-total prostate specific antigen and the prostate health index with biopsy results. Primary end points were specificity and AUC using the prostate health index to detect overall and Gleason 7 or greater prostate cancer on biopsy compared with those of free-to-total prostate specific antigen. Results: In the 2 to 10 ng/ml prostate specific antigen range at 80{\%} to 95{\%} sensitivity the specificity and AUC (0.703) of the prostate health index exceeded those of prostate specific antigen and free-to-total prostate specific antigen. An increasing prostate health index was associated with a 4.7-fold increased risk of prostate cancer and a 1.61-fold increased risk of Gleason score greater than or equal to 4 + 3 = 7 disease on biopsy. The AUC of the index exceeded that of free-to-total prostate specific antigen (0.724 vs 0.670) to discriminate prostate cancer with Gleason 4 or greater + 3 from lower grade disease or negative biopsy. Prostate health index results were not associated with age and prostate volume. Conclusions: The prostate health index may be useful in prostate cancer screening to decrease unnecessary biopsy in men 50 years old or older with prostate specific antigen 2 to 10 ng/ml and negative digital rectal examination with minimal loss in sensitivity.",
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T1 - A multicenter study of [-2]pro-prostate specific antigen combined with prostate specific antigen and free prostate specific antigen for prostate cancer detection in the 2.0 to 10.0 ng/ml prostate specific antigen range

AU - Catalona, William J.

AU - Partin, Alan W.

AU - Sanda, Martin G.

AU - Wei, John T.

AU - Klee, George G.

AU - Bangma, Chris H.

AU - Slawin, Kevin M.

AU - Marks, Leonard S.

AU - Loeb, Stacy

AU - Broyles, Dennis L.

AU - Shin, Sanghyuk S.

AU - Cruz, Amabelle B.

AU - Chan, Daniel W.

AU - Sokoll, Lori J.

AU - Roberts, William L.

AU - Van Schaik, Ron H N

AU - Mizrahi, Isaac A.

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N2 - Purpose: Prostate specific antigen and free prostate specific antigen have limited specificity to detect clinically significant, curable prostate cancer, leading to unnecessary biopsy, and detection and treatment of some indolent tumors. Specificity to detect clinically significant prostate cancer may be improved by [-2]pro-prostate specific antigen. We evaluated [-2]pro-prostate specific antigen, free prostate specific antigen and prostate specific antigen using the formula, ([-2]pro-prostate specific antigen/free prostate specific antigen × prostate specific antigen1/2) to enhance specificity to detect overall and high grade prostate cancer. Materials and Methods: We enrolled 892 men with no history of prostate cancer, normal rectal examination, prostate specific antigen 2 to 10 ng/ml and 6-core or greater prostate biopsy in a prospective multi-institutional trial. We examined the relationship of serum prostate specific antigen, free-to-total prostate specific antigen and the prostate health index with biopsy results. Primary end points were specificity and AUC using the prostate health index to detect overall and Gleason 7 or greater prostate cancer on biopsy compared with those of free-to-total prostate specific antigen. Results: In the 2 to 10 ng/ml prostate specific antigen range at 80% to 95% sensitivity the specificity and AUC (0.703) of the prostate health index exceeded those of prostate specific antigen and free-to-total prostate specific antigen. An increasing prostate health index was associated with a 4.7-fold increased risk of prostate cancer and a 1.61-fold increased risk of Gleason score greater than or equal to 4 + 3 = 7 disease on biopsy. The AUC of the index exceeded that of free-to-total prostate specific antigen (0.724 vs 0.670) to discriminate prostate cancer with Gleason 4 or greater + 3 from lower grade disease or negative biopsy. Prostate health index results were not associated with age and prostate volume. Conclusions: The prostate health index may be useful in prostate cancer screening to decrease unnecessary biopsy in men 50 years old or older with prostate specific antigen 2 to 10 ng/ml and negative digital rectal examination with minimal loss in sensitivity.

AB - Purpose: Prostate specific antigen and free prostate specific antigen have limited specificity to detect clinically significant, curable prostate cancer, leading to unnecessary biopsy, and detection and treatment of some indolent tumors. Specificity to detect clinically significant prostate cancer may be improved by [-2]pro-prostate specific antigen. We evaluated [-2]pro-prostate specific antigen, free prostate specific antigen and prostate specific antigen using the formula, ([-2]pro-prostate specific antigen/free prostate specific antigen × prostate specific antigen1/2) to enhance specificity to detect overall and high grade prostate cancer. Materials and Methods: We enrolled 892 men with no history of prostate cancer, normal rectal examination, prostate specific antigen 2 to 10 ng/ml and 6-core or greater prostate biopsy in a prospective multi-institutional trial. We examined the relationship of serum prostate specific antigen, free-to-total prostate specific antigen and the prostate health index with biopsy results. Primary end points were specificity and AUC using the prostate health index to detect overall and Gleason 7 or greater prostate cancer on biopsy compared with those of free-to-total prostate specific antigen. Results: In the 2 to 10 ng/ml prostate specific antigen range at 80% to 95% sensitivity the specificity and AUC (0.703) of the prostate health index exceeded those of prostate specific antigen and free-to-total prostate specific antigen. An increasing prostate health index was associated with a 4.7-fold increased risk of prostate cancer and a 1.61-fold increased risk of Gleason score greater than or equal to 4 + 3 = 7 disease on biopsy. The AUC of the index exceeded that of free-to-total prostate specific antigen (0.724 vs 0.670) to discriminate prostate cancer with Gleason 4 or greater + 3 from lower grade disease or negative biopsy. Prostate health index results were not associated with age and prostate volume. Conclusions: The prostate health index may be useful in prostate cancer screening to decrease unnecessary biopsy in men 50 years old or older with prostate specific antigen 2 to 10 ng/ml and negative digital rectal examination with minimal loss in sensitivity.

KW - diagnosis

KW - mass screening

KW - prostate

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KW - prostatic neoplasms

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