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• W2116372022 abstract "No AccessJournal of UrologyAdult Urology1 Nov 2012Contrast Enhanced Transrectal Ultrasound for the Detection of Prostate Cancer: A Randomized, Double-Blind Trial of Dutasteride Pretreatment Ethan J. Halpern, Leonard G. Gomella, Flemming Forsberg, Peter A. McCue, and Edouard J. Trabulsi Ethan J. HalpernEthan J. Halpern Department of Radiology, Jefferson Prostate Diagnostic Center and Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania Nothing to disclose. More articles by this author , Leonard G. GomellaLeonard G. Gomella Department of Urology, Jefferson Prostate Diagnostic Center and Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania Financial interest and/or other relationship with Astellas, Dendreon, Janssen, Bayer, Amgen, McGraw Hill, LWW, The Canadian Journal of Urology, COBI and Sanofi Aventis. More articles by this author , Flemming ForsbergFlemming Forsberg Department of Radiology, Jefferson Prostate Diagnostic Center and Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania Financial interest and/or other relationship with the Journal of Ultrasound in Medicine/American Institute of Ultrasound in Medicine, Toshiba, Siemens, Kirkland & Ellis LLP (Expert Witness) and Dewey & LeBoeuf LLP (Expert Witness). More articles by this author , Peter A. McCuePeter A. McCue Department of Pathology, Jefferson Prostate Diagnostic Center and Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania Nothing to disclose. More articles by this author , and Edouard J. TrabulsiEdouard J. Trabulsi Department of Urology, Jefferson Prostate Diagnostic Center and Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania Financial interest and/or other relationship with Lantheus Medical Imaging, Centocor, Amgen and Dendreon. More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.07.021AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: The identification of clinically significant disease is crucial for optimal treatment of prostate cancer. Selective detection of prostate cancer with increased microvessel density is possible with contrast enhanced ultrasound. Preliminary studies suggest that pretreatment with a 5α-reductase inhibitor may improve the efficiency of contrast enhanced ultrasound targeted biopsy. This study was designed to quantify prostate cancer detection with contrast enhanced ultrasound with or without short-term pretreatment with dutasteride. Materials and Methods: In this randomized, double-blind, placebo controlled trial of oral dutasteride pretreatment, contrast enhanced ultrasound findings were graded and used to direct targeted biopsy (up to 6 cores per prostate). A blinded 12-core systematic biopsy was subsequently performed on every subject based on standard medial and lateral sampling of each sextant. Results: Of 311 subjects who underwent randomization, 272 completed participation. Positive biopsies were obtained in 276 of 3,264 (8.5%) systematic cores and 203 of 1,237 (16.4%) targeted cores (OR 2.1, 95% CI 1.7–2.6, p <0.001). ROC analysis for the detection of all prostate cancers demonstrated an increase in diagnostic accuracy from pre-contrast imaging to contrast enhanced ultrasound (Az 0.60 vs 0.64, p = 0.005). For the detection of high grade cancer (Gleason score 7 or greater) ROC analysis demonstrated improved accuracy for pre-contrast imaging (Az 0.74) and contrast enhanced ultrasound (Az 0.80, p = 0.0005). For the detection of high grade cancer with greater than 50% biopsy core involvement, excellent accuracy was demonstrated with pre-contrast and contrast enhanced ultrasound, Az 0.83 and 0.90, respectively (p = 0.001). Pretreatment with dutasteride had no significant impact on the detection of prostate cancer (p = 0.97). Conclusions: Contrast enhanced ultrasound targeted biopsy provides a significant benefit for the detection of high grade/high volume prostate cancer. References 1 : Random systematic versus directed ultrasound guided transrectal core biopsies of the prostate. J Urol1989; 142: 71. Link, Google Scholar 2 : Clinical and pathologic tumor characteristics of prostate cancer as a function of the number of biopsy cores: a retrospective study. Urology1998; 52: 808. Crossref, Medline, Google Scholar 3 : Increasing prostate biopsy cores based on volume vs the sextant biopsy: a prospective randomized controlled clinical study on cancer detection rates and morbidity. 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Google Scholar 21 : Contrast-enhanced colour Doppler-targeted prostate biopsy: correlation of a subjective blood-flow rating scale with the histopathological outcome of the biopsy. BJU Int2010; 106: 1315. Google Scholar 22 : Comparing areas under receiver operating characteristic curves from two or more probit or logit models. Stata J2002; 2: 301. Google Scholar 23 : Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics1988; 44: 837. Google Scholar 24 : A prospective randomized trial comparing contrast-enhanced targeted versus systematic ultrasound guided biopsies: impact on prostate cancer detection. Prostate2007; 67: 1537. Google Scholar 25 : Contrast-enhanced colour Doppler-targeted vs a 10-core systematic repeat biopsy strategy in patients with previous high-grade prostatic intraepithelial neoplasia. BJU Int2010; 105: 1660. 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Google Scholar © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byPloussard G (2012) How Much Should We Pursue an Elevated Prostate Specific Antigen?Journal of Urology, VOL. 188, NO. 5, (1658-1659), Online publication date: 1-Nov-2012.Steers W (2012) This Month in Adult UrologyJournal of Urology, VOL. 188, NO. 5, (1649-1650), Online publication date: 1-Nov-2012. Volume 188Issue 5November 2012Page: 1739-1745 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.Keywordsbiopsymicrovesselsultrasonographyprostatic neoplasmscontrast mediaAcknowledgmentsThe contrast material for this trial (DEFINITY) was supplied by Lantheus Medical Imaging, North Billerica, Massachusetts. The dutasteride and placebo were supplied by GlaxoSmithKline, Research Triangle Park, North Carolina. The Aplio ultrasound system was supplied by Toshiba America Medical Systems, Tustin, California.Donna George cared for all patients during the biopsy procedure. Study coordinators Colleen Dascenzo, Nancy Pedano, Andrea Frangos, Christine Hubert, Kelly Coggins and Karen Milsip managed patient recruitment, scheduling and data collection. The urology residents at Thomas Jefferson University assisted with data collection and biopsy procedures, including Drs. Eric Nelson, Paul Gittens, Robert Linden, Mark Pe, Jitesh Patel, James Johannes, Steve Dong, Joseph (JR) Zola, Adeep Thumar, Daniel Sackett, Chandan Kundavaram, Xiaolong (Shawn) Liu and Francisco Gelpi-Hammerschmidt. Prof. Mario Cleves provided assistance with the logistic model to perform ROC analysis in Stata.MetricsAuthor Information Ethan J. Halpern Department of Radiology, Jefferson Prostate Diagnostic Center and Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania Nothing to disclose. More articles by this author Leonard G. Gomella Department of Urology, Jefferson Prostate Diagnostic Center and Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania Financial interest and/or other relationship with Astellas, Dendreon, Janssen, Bayer, Amgen, McGraw Hill, LWW, The Canadian Journal of Urology, COBI and Sanofi Aventis. More articles by this author Flemming Forsberg Department of Radiology, Jefferson Prostate Diagnostic Center and Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania Financial interest and/or other relationship with the Journal of Ultrasound in Medicine/American Institute of Ultrasound in Medicine, Toshiba, Siemens, Kirkland & Ellis LLP (Expert Witness) and Dewey & LeBoeuf LLP (Expert Witness). More articles by this author Peter A. McCue Department of Pathology, Jefferson Prostate Diagnostic Center and Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania Nothing to disclose. More articles by this author Edouard J. Trabulsi Department of Urology, Jefferson Prostate Diagnostic Center and Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania Financial interest and/or other relationship with Lantheus Medical Imaging, Centocor, Amgen and Dendreon. More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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