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Table of Contents
Vol. 35, No. 5-6, 1999
Issue release date: May–June 1999
Section title: Clinical Trial Designs for Chemoprevention of Prostate Cancer
Eur Urol 1999;35:544–547
(DOI:10.1159/000019895)

Prostate Cancer Prevention Trial (PCPT) Update

Thompson, Jr. I.M. · Feigl P.
aSouthwest Oncology Group; bBrooke Army Medical Center, San Antonio, Tex., and cFred Hutchinson Cancer Research Center, Seattle, Wash., USA

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Article / Publication Details

First-Page Preview
Abstract of Clinical Trial Designs for Chemoprevention of Prostate Cancer

Published online: 4/16/2012

Number of Print Pages: 4
Number of Figures: 0
Number of Tables: 6

ISSN: 0302-2838 (Print)
eISSN: 1421-993X (Online)

For additional information: http://www.karger.com/EUR

Abstract

The Prostate Cancer Prevention Trial is an intergroup effort in the USA managed by the Southwest Oncology Group (SWOG) in collaboration with the Eastern Cooperative Oncology Group (ECOG) and the Cancer and Leukemia Group B (CALGB). This 10-year study began approximately 5 years ago and will achieve its primary endpoint in October 2004. At the start of the study, 18,882 men, aged over 55 years, and with normal digital rectal examination (DRE) and serum prostate-specific antigen (PSA) levels of ≤3.0 ng/ml were randomized to take finasteride (5 mg/day) or placebo (1 tablet/day). DRE and PSA have been determined yearly (PSA in a central laboratory). When DRE is abnormal or PSA rises to >4.0 ng/ml, a biopsy is recommended. Because of the effect finasteride has on PSA, the PSA value has been indexed to equalize the number of biopsies in both arms. At 7 years all survivors will undergo a sextant biopsy to determine the period prevalence of prostate cancer. The critical assumptions are: (1) finasteride-induced PSA changes result in a simple downward shift; (2) the assessment of adherence is sensitive enough to detect nonadherence affecting PSA level interpretation: (3) factors affecting biopsy loss will be equal in both arms; (4) finasteride does not affect the sensitivity or specificity of DRE on transrectal ultrasound nor the sensitivity of biopsy; (5) bias resulting from transurethral resection of the prostate in benign prostate hyperplasia cases will be negligible.


Article / Publication Details

First-Page Preview
Abstract of Clinical Trial Designs for Chemoprevention of Prostate Cancer

Published online: 4/16/2012

Number of Print Pages: 4
Number of Figures: 0
Number of Tables: 6

ISSN: 0302-2838 (Print)
eISSN: 1421-993X (Online)

For additional information: http://www.karger.com/EUR


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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