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
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 doubl...
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| Published in: | Urology (Ridgewood, N.J.) Vol. 52; no. 2; pp. 195 - 202 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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Elsevier Inc
01-08-1998
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| 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. |
|---|---|
| AbstractList | 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 | Hudson, P. Patterson, L. Epstein, J.I. Romas, N.A. Andriole, G.L. Guess, H.A. Kadmon, D. Crawford, E.D. Wise, H. Cook, T.J. Jackson, C.L. Waldstreicher, J. |
| Author_xml | – sequence: 1 givenname: G.L. surname: Andriole fullname: Andriole, G.L. organization: Division of Urology, Washington University School of Medicine, St. Louis, Missouri, USA – sequence: 2 givenname: H.A. surname: Guess fullname: Guess, H.A. organization: Merck, Inc., Rahway, New Jersey, USA – sequence: 3 givenname: J.I. surname: Epstein fullname: Epstein, J.I. organization: Department of Pathology, Johns Hopkins Hospital, Baltimore, Maryland, USA – sequence: 4 givenname: H. surname: Wise fullname: Wise, H. organization: Ohio Urology, Columbus, Ohio, USA – sequence: 5 givenname: D. surname: Kadmon fullname: Kadmon, D. organization: Baylor College of Medicine, Houston, Texas, USA – sequence: 6 givenname: E.D. surname: Crawford fullname: Crawford, E.D. organization: University of Colorado, Denver, Colorado, USA – sequence: 7 givenname: P. surname: Hudson fullname: Hudson, P. organization: Department of Veterans Affairs Medical Center, Bay Pines, Florida, USA – sequence: 8 givenname: C.L. surname: Jackson fullname: Jackson, C.L. organization: Cleveland Clinic Foundation, Ft. Lauderdale, Florida, USA – sequence: 9 givenname: N.A. surname: Romas fullname: Romas, N.A. organization: St. Luke’s Roosevelt Hospital, New York, New York, USA – sequence: 10 givenname: L. surname: Patterson fullname: Patterson, L. organization: University of Tennessee, Memphis, Tennessee, USA – sequence: 11 givenname: T.J. surname: Cook fullname: Cook, T.J. organization: Merck, Inc., Rahway, New Jersey, USA – sequence: 12 givenname: J. surname: Waldstreicher fullname: Waldstreicher, J. organization: Merck, Inc., Rahway, New Jersey, USA |
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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 |
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