Derivation and application of upper limits for prostate specific antigen in men aged 50–74 years with no clinical evidence of prostatic carcinoma

B. L. DALKIN, F. R. AHMANN, J. B. KOPP, W. J. CATALONA, T. L. RATLIFF, M. A. HUDSON, J. P. RICHIE, P. T. SCARDINO, R. C. FLANIGAN, J. B. DEKERNION, W Waters, L. R. KAVOUSSI, M. T. MACFARLANE

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Abstract

Objective To derive age‐specific upper limits for prostate specific antigen (PSA) level in men 50–74 years of age with no clinical evidence of prostatic carcinoma, and to test the sensitivity and specificity for cancer detection of these upper limits. Subjects and methods A total of 6166 men were recruited for a multicentre study of prostate cancer detection and underwent a serum PSA determination and digital rectal examination (DRE). Men considered to be clinically free of prostatic carcinoma were those with a normal DRE and a PSA level ≤ 4.0 ng/mL, and men with an abnormality in either parameter who underwent ultrasonography‐guided prostate biopsy that revealed no evidence of carcinoma. By these criteria, 5469 men had no evidence of prostatic carcinoma. Dividing the population into 5‐year age increments, three statistical methods were assessed to derive upper limits for serum PSA level by age; the mean +2 sd, the 99th percentile, and a 97.5% prediction interval based on linear regression. Results Newly‐derived upper limits calculated by each method in the 50–54 and the 70–74 age group were 3.9 ng/mL and 7.6 ng/mL (mean + 2 sd), 5.2 ng/mL and 14.0 ng/mL (99th percentile), and 4.7 ng/mL and 8.2 ng/mL (97.5% prediction interval). The sensitivity of the newly‐derived upper limits was tested using receiver operating characteristic curves derived from men with no suspicious findings on DRE and a serum PSA concentration > 4.0 ng/mL. Although the specificity of the test increased with increasing PSA upper limits, no upper limits derived from these three methods yielded adequate sensitivity to detect cancer; sensitivities by age range were from 53 to 94%, using mean + 2 sd, from 25 to 50% with the 99th percentile, and from 47 to 64% with the 97.5% prediction interval. Conclusion We do not recommend age‐referenced adjustments in upper limits for serum PSA concentration, but recommend that an upper limit of 4.0 ng/mL be used in all men 50–74 years of age.

Original languageEnglish (US)
Pages (from-to)346-350
Number of pages5
JournalBritish Journal of Urology
Volume76
Issue number3
DOIs
StatePublished - Jan 1 1995
Externally publishedYes

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Prostate-Specific Antigen
Carcinoma
Digital Rectal Examination
Serum
ROC Curve
Multicenter Studies
Limit of Detection
Prostate
Linear Models
Neoplasms
Prostatic Neoplasms
Age Groups
Biopsy
Sensitivity and Specificity
Population

All Science Journal Classification (ASJC) codes

  • Urology

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Derivation and application of upper limits for prostate specific antigen in men aged 50–74 years with no clinical evidence of prostatic carcinoma. / DALKIN, B. L.; AHMANN, F. R.; KOPP, J. B.; CATALONA, W. J.; RATLIFF, T. L.; HUDSON, M. A.; RICHIE, J. P.; SCARDINO, P. T.; FLANIGAN, R. C.; DEKERNION, J. B.; Waters, W; KAVOUSSI, L. R.; MACFARLANE, M. T.

In: British Journal of Urology, Vol. 76, No. 3, 01.01.1995, p. 346-350.

Research output: Contribution to journalArticle

DALKIN, BL, AHMANN, FR, KOPP, JB, CATALONA, WJ, RATLIFF, TL, HUDSON, MA, RICHIE, JP, SCARDINO, PT, FLANIGAN, RC, DEKERNION, JB, Waters, W, KAVOUSSI, LR & MACFARLANE, MT 1995, 'Derivation and application of upper limits for prostate specific antigen in men aged 50–74 years with no clinical evidence of prostatic carcinoma', British Journal of Urology, vol. 76, no. 3, pp. 346-350. https://doi.org/10.1111/j.1464-410X.1995.tb07712.x
DALKIN, B. L. ; AHMANN, F. R. ; KOPP, J. B. ; CATALONA, W. J. ; RATLIFF, T. L. ; HUDSON, M. A. ; RICHIE, J. P. ; SCARDINO, P. T. ; FLANIGAN, R. C. ; DEKERNION, J. B. ; Waters, W ; KAVOUSSI, L. R. ; MACFARLANE, M. T. / Derivation and application of upper limits for prostate specific antigen in men aged 50–74 years with no clinical evidence of prostatic carcinoma. In: British Journal of Urology. 1995 ; Vol. 76, No. 3. pp. 346-350.
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abstract = "Objective To derive age‐specific upper limits for prostate specific antigen (PSA) level in men 50–74 years of age with no clinical evidence of prostatic carcinoma, and to test the sensitivity and specificity for cancer detection of these upper limits. Subjects and methods A total of 6166 men were recruited for a multicentre study of prostate cancer detection and underwent a serum PSA determination and digital rectal examination (DRE). Men considered to be clinically free of prostatic carcinoma were those with a normal DRE and a PSA level ≤ 4.0 ng/mL, and men with an abnormality in either parameter who underwent ultrasonography‐guided prostate biopsy that revealed no evidence of carcinoma. By these criteria, 5469 men had no evidence of prostatic carcinoma. Dividing the population into 5‐year age increments, three statistical methods were assessed to derive upper limits for serum PSA level by age; the mean +2 sd, the 99th percentile, and a 97.5{\%} prediction interval based on linear regression. Results Newly‐derived upper limits calculated by each method in the 50–54 and the 70–74 age group were 3.9 ng/mL and 7.6 ng/mL (mean + 2 sd), 5.2 ng/mL and 14.0 ng/mL (99th percentile), and 4.7 ng/mL and 8.2 ng/mL (97.5{\%} prediction interval). The sensitivity of the newly‐derived upper limits was tested using receiver operating characteristic curves derived from men with no suspicious findings on DRE and a serum PSA concentration > 4.0 ng/mL. Although the specificity of the test increased with increasing PSA upper limits, no upper limits derived from these three methods yielded adequate sensitivity to detect cancer; sensitivities by age range were from 53 to 94{\%}, using mean + 2 sd, from 25 to 50{\%} with the 99th percentile, and from 47 to 64{\%} with the 97.5{\%} prediction interval. Conclusion We do not recommend age‐referenced adjustments in upper limits for serum PSA concentration, but recommend that an upper limit of 4.0 ng/mL be used in all men 50–74 years of age.",
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T1 - Derivation and application of upper limits for prostate specific antigen in men aged 50–74 years with no clinical evidence of prostatic carcinoma

AU - DALKIN, B. L.

AU - AHMANN, F. R.

AU - KOPP, J. B.

AU - CATALONA, W. J.

AU - RATLIFF, T. L.

AU - HUDSON, M. A.

AU - RICHIE, J. P.

AU - SCARDINO, P. T.

AU - FLANIGAN, R. C.

AU - DEKERNION, J. B.

AU - Waters, W

AU - KAVOUSSI, L. R.

AU - MACFARLANE, M. T.

PY - 1995/1/1

Y1 - 1995/1/1

N2 - Objective To derive age‐specific upper limits for prostate specific antigen (PSA) level in men 50–74 years of age with no clinical evidence of prostatic carcinoma, and to test the sensitivity and specificity for cancer detection of these upper limits. Subjects and methods A total of 6166 men were recruited for a multicentre study of prostate cancer detection and underwent a serum PSA determination and digital rectal examination (DRE). Men considered to be clinically free of prostatic carcinoma were those with a normal DRE and a PSA level ≤ 4.0 ng/mL, and men with an abnormality in either parameter who underwent ultrasonography‐guided prostate biopsy that revealed no evidence of carcinoma. By these criteria, 5469 men had no evidence of prostatic carcinoma. Dividing the population into 5‐year age increments, three statistical methods were assessed to derive upper limits for serum PSA level by age; the mean +2 sd, the 99th percentile, and a 97.5% prediction interval based on linear regression. Results Newly‐derived upper limits calculated by each method in the 50–54 and the 70–74 age group were 3.9 ng/mL and 7.6 ng/mL (mean + 2 sd), 5.2 ng/mL and 14.0 ng/mL (99th percentile), and 4.7 ng/mL and 8.2 ng/mL (97.5% prediction interval). The sensitivity of the newly‐derived upper limits was tested using receiver operating characteristic curves derived from men with no suspicious findings on DRE and a serum PSA concentration > 4.0 ng/mL. Although the specificity of the test increased with increasing PSA upper limits, no upper limits derived from these three methods yielded adequate sensitivity to detect cancer; sensitivities by age range were from 53 to 94%, using mean + 2 sd, from 25 to 50% with the 99th percentile, and from 47 to 64% with the 97.5% prediction interval. Conclusion We do not recommend age‐referenced adjustments in upper limits for serum PSA concentration, but recommend that an upper limit of 4.0 ng/mL be used in all men 50–74 years of age.

AB - Objective To derive age‐specific upper limits for prostate specific antigen (PSA) level in men 50–74 years of age with no clinical evidence of prostatic carcinoma, and to test the sensitivity and specificity for cancer detection of these upper limits. Subjects and methods A total of 6166 men were recruited for a multicentre study of prostate cancer detection and underwent a serum PSA determination and digital rectal examination (DRE). Men considered to be clinically free of prostatic carcinoma were those with a normal DRE and a PSA level ≤ 4.0 ng/mL, and men with an abnormality in either parameter who underwent ultrasonography‐guided prostate biopsy that revealed no evidence of carcinoma. By these criteria, 5469 men had no evidence of prostatic carcinoma. Dividing the population into 5‐year age increments, three statistical methods were assessed to derive upper limits for serum PSA level by age; the mean +2 sd, the 99th percentile, and a 97.5% prediction interval based on linear regression. Results Newly‐derived upper limits calculated by each method in the 50–54 and the 70–74 age group were 3.9 ng/mL and 7.6 ng/mL (mean + 2 sd), 5.2 ng/mL and 14.0 ng/mL (99th percentile), and 4.7 ng/mL and 8.2 ng/mL (97.5% prediction interval). The sensitivity of the newly‐derived upper limits was tested using receiver operating characteristic curves derived from men with no suspicious findings on DRE and a serum PSA concentration > 4.0 ng/mL. Although the specificity of the test increased with increasing PSA upper limits, no upper limits derived from these three methods yielded adequate sensitivity to detect cancer; sensitivities by age range were from 53 to 94%, using mean + 2 sd, from 25 to 50% with the 99th percentile, and from 47 to 64% with the 97.5% prediction interval. Conclusion We do not recommend age‐referenced adjustments in upper limits for serum PSA concentration, but recommend that an upper limit of 4.0 ng/mL be used in all men 50–74 years of age.

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