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• W2072040384 abstract "No AccessJournal of UrologyAdult Urology: Oncology: Prostate/Testis/Penis/Urethra1 Mar 2005A RANDOMIZED, PHASE II TRIAL OF KETOCONAZOLE PLUS ALENDRONATE VERSUS KETOCONAZOLE ALONE IN PATIENTS WITH ANDROGEN INDEPENDENT PROSTATE CANCER AND BONE METASTASES WILLIAM D. FIGG, YINONG LIU, PHILIP ARLEN, JAMES GULLEY, SETH M. STEINBERG, DAVID J. LIEWEHR, MICHAEL C. COX, SUOPING ZHAI, SERGE CREMERS, ALLYSON PARR, XIAOWEI YANG, CLARA C. CHEN, ELIZABETH JONES, and WILLIAM L. DAHUT WILLIAM D. FIGGWILLIAM D. FIGG More articles by this author , YINONG LIUYINONG LIU More articles by this author , PHILIP ARLENPHILIP ARLEN More articles by this author , JAMES GULLEYJAMES GULLEY More articles by this author , SETH M. STEINBERGSETH M. STEINBERG More articles by this author , DAVID J. LIEWEHRDAVID J. LIEWEHR More articles by this author , MICHAEL C. COXMICHAEL C. COX More articles by this author , SUOPING ZHAISUOPING ZHAI More articles by this author , SERGE CREMERSSERGE CREMERS More articles by this author , ALLYSON PARRALLYSON PARR More articles by this author , XIAOWEI YANGXIAOWEI YANG More articles by this author , CLARA C. CHENCLARA C. CHEN More articles by this author , ELIZABETH JONESELIZABETH JONES More articles by this author , and WILLIAM L. DAHUTWILLIAM L. DAHUT More articles by this author View All Author Informationhttps://doi.org/10.1097/01.ju.0000147013.09157.8eAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Alendronate (AL), a potent oral bisphosphonate, blocks the secretion of matrix metalloproteinase-2 and the establishment of bone metastases in animal models. Ketoconazole (KT) has demonstrated activity in androgen independent prostate cancer (AIPC). In this study we determined whether KT plus AL produced acceptable disease responses compared with KT alone. As the experimental design, 72 patients with progressive AIPC metastatic to bone were randomized to receive KT (1,200 mg daily) plus hydrocortisone (H) (30 mg daily) with or without AL (40 mg daily). Prostate specific antigen (PSA) consensus criteria and radiographic scans were used to determine the proportion of patients with a PSA decrease, time to progression and response duration. The pharmacokinetics of KT and AL were characterized and changes in circulating angiogenic factors were assessed. Results: At a median potential followup of 23.9 months the proportion of patients with a greater than 50% decrease in PSA was similar in the KT/H/AL and KT/H, groups (50% and 47%, respectively). The median duration of response was 8.9 and 6.3 months in the KT/H/AL and KT/H groups, respectively (p = 0.125). Median progression-free survival was not significantly prolonged in the KT/H/AL group (4.6 vs 3.8 months, p = 0.27). There was no significant difference in overall survival between the 2 treatment arms but there was a trend toward improved survival in the KT/H arm (p = 0.074). Toxicity in the 2 groups was mild and there were no clear associations between changes in circulating angiogenic factor levels and clinical outcomes in either treatment arm. Conclusions: There were no statistically significant differences in response rate, progression-free survival or overall survival between KT/H alone and KT/H plus AL treatment in patients with AIPC. The addition of AL to KT/H may increase the response duration with an acceptable safety profile compared with treatment with KT/H alone. However, the addition of AL offers no survival benefit in patients with AIPC. References 1 : Cancer statistics, 2003. CA Cancer J Clin2003; 53: 5. 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Google Scholar From the Center for Cancer Research, National Cancer Institute (WDF, YL, PA, JG, SMS, DJL, MCC, SZ, AP, XY, WLD) and Departments of Nuclear Medicine (CCC) and Diagnostic Radiology (EJ), Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland, and Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center (SC), Leiden, The Netherlands© 2005 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byAssimos D (2018) Re: Persistence of 1,25D-Induced Hypercalciuria in Alendronate Treated Genetic Hypercalciuric Stone-Forming Rats Fed a Low Calcium DietJournal of Urology, VOL. 192, NO. 2, (615-615), Online publication date: 1-Aug-2014.Molina A and Belldegrun A (2018) Novel Therapeutic Strategies for Castration Resistant Prostate Cancer: Inhibition of Persistent Androgen Production and Androgen Receptor Mediated SignalingJournal of Urology, VOL. 185, NO. 3, (787-794), Online publication date: 1-Mar-2011.Figg W, Woo S, Zhu W, Chen X, Ajiboye A, Steinberg S, Price D, Wright J, Parnes H, Arlen P, Gulley J and Dahut W (2018) A Phase I Clinical Study of High Dose Ketoconazole Plus Weekly Docetaxel for Metastatic Castration Resistant Prostate CancerJournal of Urology, VOL. 183, NO. 6, (2219-2226), Online publication date: 1-Jun-2010.Ryan C and Beer T (2007) Prostate Specific Antigen Only Androgen Independent Prostate Cancer: Natural History, Challenges in Management and Clinical Trial DesignJournal of Urology, VOL. 178, NO. 3S, (S25-S29), Online publication date: 1-Sep-2007.Small E and Ryan C (2018) The Case for Secondary Hormonal Therapies in the Chemotherapy AgeJournal of Urology, VOL. 176, NO. 6S, (S66-S71), Online publication date: 1-Dec-2006. Volume 173Issue 3March 2005Page: 790-796 Advertisement Copyright & Permissions© 2005 by American Urological Association, Inc.Keywordsalendronateketoconazolepharmacokineticsprostatic neoplasmsprostateMetricsAuthor Information WILLIAM D. FIGG More articles by this author YINONG LIU More articles by this author PHILIP ARLEN More articles by this author JAMES GULLEY More articles by this author SETH M. STEINBERG More articles by this author DAVID J. LIEWEHR More articles by this author MICHAEL C. COX More articles by this author SUOPING ZHAI More articles by this author SERGE CREMERS More articles by this author ALLYSON PARR More articles by this author XIAOWEI YANG More articles by this author CLARA C. CHEN More articles by this author ELIZABETH JONES More articles by this author WILLIAM L. DAHUT More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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