Treatment with finasteride preserves usefulness of Prostate-Specific Antigen in the detection of prostate cancer: Results of a randomized, double- blind, placebo-controlled clinical trial

Gerald L. Andriole, H. A. Guess, Jonathan Ira Epstein, H. Wise, D. Kadmon, E. D. Crawford, P. Hudson, C. L. Jackson, N. A. Romas, L. Patterson, T. J. Cook, J. Waldstreicher

Research output: Contribution to journalArticle

Abstract

Objectives. To evaluate prostate cancer detection and prostate-specific antigen (PSA) among men with benign prostatic hyperplasia treated with finasteride. Methods. Three thousand forty men 45 to 78 years of age with PSA less than 10 ng/mL and no history of prostate cancer were randomized in a double-blind, placebo-controlled trial to finasteride (n = 1524) or placebo (n = 1516) for up to 4 years. A prerandomization biopsy negative for prostate cancer was obtained in 98% of patients with a screening PSA of 4.0 ng/mL or more, and an end-of-study biopsy was requested of all such patients without a recent second negative biopsy or a prostate cancer diagnosis. Results. Overall, 644 patients (21%) underwent biopsy and 201 (6.6%) underwent transurethral resection of the prostate. Prostate cancer was diagnosed in 4.7% of men on finasteride and 5.1% on placebo (P = 0.7). Elevated PSA prompted diagnosis in 35% of cases on finasteride and 34% on placebo. The area under the receiver operating characteristic curve for last PSA was 0.84 on finasteride and 0.79 on placebo (P = 0.07). Use of an upper limit of normal for last PSA of 2.0 ng/mL for finasteride and 4.0 ng/mL for placebo yielded similar sensitivity (66% versus 70%, P = 0.6), higher specificity (82% versus 74%, P <0.0001), and a higher likelihood ratio (3.6 versus 2.7, P <0.05) for finasteride than for placebo. Conclusions. In men treated with finasteride, multiplying PSA by 2 and using normal ranges for untreated men preserves the usefulness of PSA for prostate cancer detection.

Original languageEnglish (US)
Pages (from-to)195-202
Number of pages8
JournalUrology
Volume52
Issue number2
DOIs
StatePublished - Aug 1998
Externally publishedYes

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Finasteride
Controlled Clinical Trials
Prostate-Specific Antigen
Prostatic Neoplasms
Placebos
Biopsy
Therapeutics
Transurethral Resection of Prostate
Prostatic Hyperplasia
ROC Curve
Reference Values

ASJC Scopus subject areas

  • Urology

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Treatment with finasteride preserves usefulness of Prostate-Specific Antigen in the detection of prostate cancer : Results of a randomized, double- blind, placebo-controlled clinical trial. / Andriole, Gerald L.; Guess, H. A.; Epstein, Jonathan Ira; Wise, H.; Kadmon, D.; Crawford, E. D.; Hudson, P.; Jackson, C. L.; Romas, N. A.; Patterson, L.; Cook, T. J.; Waldstreicher, J.

In: Urology, Vol. 52, No. 2, 08.1998, p. 195-202.

Research output: Contribution to journalArticle

Andriole, GL, Guess, HA, Epstein, JI, Wise, H, Kadmon, D, Crawford, ED, Hudson, P, Jackson, CL, Romas, NA, Patterson, L, Cook, TJ & Waldstreicher, J 1998, 'Treatment with finasteride preserves usefulness of Prostate-Specific Antigen in the detection of prostate cancer: Results of a randomized, double- blind, placebo-controlled clinical trial', Urology, vol. 52, no. 2, pp. 195-202. https://doi.org/10.1016/S0090-4295(98)00184-8
Andriole, Gerald L. ; Guess, H. A. ; Epstein, Jonathan Ira ; Wise, H. ; Kadmon, D. ; Crawford, E. D. ; Hudson, P. ; Jackson, C. L. ; Romas, N. A. ; Patterson, L. ; Cook, T. J. ; Waldstreicher, J. / Treatment with finasteride preserves usefulness of Prostate-Specific Antigen in the detection of prostate cancer : Results of a randomized, double- blind, placebo-controlled clinical trial. In: Urology. 1998 ; Vol. 52, No. 2. pp. 195-202.
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title = "Treatment with finasteride preserves usefulness of Prostate-Specific Antigen in the detection of prostate cancer: Results of a randomized, double- blind, placebo-controlled clinical trial",
abstract = "Objectives. To evaluate prostate cancer detection and prostate-specific antigen (PSA) among men with benign prostatic hyperplasia treated with finasteride. Methods. Three thousand forty men 45 to 78 years of age with PSA less than 10 ng/mL and no history of prostate cancer were randomized in a double-blind, placebo-controlled trial to finasteride (n = 1524) or placebo (n = 1516) for up to 4 years. A prerandomization biopsy negative for prostate cancer was obtained in 98{\%} of patients with a screening PSA of 4.0 ng/mL or more, and an end-of-study biopsy was requested of all such patients without a recent second negative biopsy or a prostate cancer diagnosis. Results. Overall, 644 patients (21{\%}) underwent biopsy and 201 (6.6{\%}) underwent transurethral resection of the prostate. Prostate cancer was diagnosed in 4.7{\%} of men on finasteride and 5.1{\%} on placebo (P = 0.7). Elevated PSA prompted diagnosis in 35{\%} of cases on finasteride and 34{\%} on placebo. The area under the receiver operating characteristic curve for last PSA was 0.84 on finasteride and 0.79 on placebo (P = 0.07). Use of an upper limit of normal for last PSA of 2.0 ng/mL for finasteride and 4.0 ng/mL for placebo yielded similar sensitivity (66{\%} versus 70{\%}, P = 0.6), higher specificity (82{\%} versus 74{\%}, P <0.0001), and a higher likelihood ratio (3.6 versus 2.7, P <0.05) for finasteride than for placebo. Conclusions. In men treated with finasteride, multiplying PSA by 2 and using normal ranges for untreated men preserves the usefulness of PSA for prostate cancer detection.",
author = "Andriole, {Gerald L.} and Guess, {H. A.} and Epstein, {Jonathan Ira} and H. Wise and D. Kadmon and Crawford, {E. D.} and P. Hudson and Jackson, {C. L.} and Romas, {N. A.} and L. Patterson and Cook, {T. J.} and J. Waldstreicher",
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T1 - Treatment with finasteride preserves usefulness of Prostate-Specific Antigen in the detection of prostate cancer

T2 - Results of a randomized, double- blind, placebo-controlled clinical trial

AU - Andriole, Gerald L.

AU - Guess, H. A.

AU - Epstein, Jonathan Ira

AU - Wise, H.

AU - Kadmon, D.

AU - Crawford, E. D.

AU - Hudson, P.

AU - Jackson, C. L.

AU - Romas, N. A.

AU - Patterson, L.

AU - Cook, T. J.

AU - Waldstreicher, J.

PY - 1998/8

Y1 - 1998/8

N2 - Objectives. To evaluate prostate cancer detection and prostate-specific antigen (PSA) among men with benign prostatic hyperplasia treated with finasteride. Methods. Three thousand forty men 45 to 78 years of age with PSA less than 10 ng/mL and no history of prostate cancer were randomized in a double-blind, placebo-controlled trial to finasteride (n = 1524) or placebo (n = 1516) for up to 4 years. A prerandomization biopsy negative for prostate cancer was obtained in 98% of patients with a screening PSA of 4.0 ng/mL or more, and an end-of-study biopsy was requested of all such patients without a recent second negative biopsy or a prostate cancer diagnosis. Results. Overall, 644 patients (21%) underwent biopsy and 201 (6.6%) underwent transurethral resection of the prostate. Prostate cancer was diagnosed in 4.7% of men on finasteride and 5.1% on placebo (P = 0.7). Elevated PSA prompted diagnosis in 35% of cases on finasteride and 34% on placebo. The area under the receiver operating characteristic curve for last PSA was 0.84 on finasteride and 0.79 on placebo (P = 0.07). Use of an upper limit of normal for last PSA of 2.0 ng/mL for finasteride and 4.0 ng/mL for placebo yielded similar sensitivity (66% versus 70%, P = 0.6), higher specificity (82% versus 74%, P <0.0001), and a higher likelihood ratio (3.6 versus 2.7, P <0.05) for finasteride than for placebo. Conclusions. In men treated with finasteride, multiplying PSA by 2 and using normal ranges for untreated men preserves the usefulness of PSA for prostate cancer detection.

AB - Objectives. To evaluate prostate cancer detection and prostate-specific antigen (PSA) among men with benign prostatic hyperplasia treated with finasteride. Methods. Three thousand forty men 45 to 78 years of age with PSA less than 10 ng/mL and no history of prostate cancer were randomized in a double-blind, placebo-controlled trial to finasteride (n = 1524) or placebo (n = 1516) for up to 4 years. A prerandomization biopsy negative for prostate cancer was obtained in 98% of patients with a screening PSA of 4.0 ng/mL or more, and an end-of-study biopsy was requested of all such patients without a recent second negative biopsy or a prostate cancer diagnosis. Results. Overall, 644 patients (21%) underwent biopsy and 201 (6.6%) underwent transurethral resection of the prostate. Prostate cancer was diagnosed in 4.7% of men on finasteride and 5.1% on placebo (P = 0.7). Elevated PSA prompted diagnosis in 35% of cases on finasteride and 34% on placebo. The area under the receiver operating characteristic curve for last PSA was 0.84 on finasteride and 0.79 on placebo (P = 0.07). Use of an upper limit of normal for last PSA of 2.0 ng/mL for finasteride and 4.0 ng/mL for placebo yielded similar sensitivity (66% versus 70%, P = 0.6), higher specificity (82% versus 74%, P <0.0001), and a higher likelihood ratio (3.6 versus 2.7, P <0.05) for finasteride than for placebo. Conclusions. In men treated with finasteride, multiplying PSA by 2 and using normal ranges for untreated men preserves the usefulness of PSA for prostate cancer detection.

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